June 2011

SGS To Open Mumbai Facility

Posted on June 1, 2011 @ 09:47 am

SGS plans to open its second Life Science Services facility in Mumbai, India, which is expected to be fully operational by mid-2012. This investment will establish a dedicated GMP lab to provide a range of analytical development and quality control testing services. It includes a lab for new or expanded services in stability testing, extractables and leachables, analytical chemistry, and microbiology. SGS will also invest in the latest generation of mass spectrometers and stability chambers to increase testing and sample storage capacities. The 15,000-sq.-ft. facility will initially employ 20 staff and as many as 90 additional positions in the next five years.

“This investment is part of the three-year growth plan for SGS India and the Life Science Services division,” said Anne Hays, executive vice president for SGS Life Science Services “With the growth of the pharmaceutical market in India, and specifically Mumbai, SGS takes this initiative to be in physically closer to our customers, while maintaining the quality we deliver, building our service offerings, and expanding our global network of laboratories.”

Evotec Acquires Galapagos Unit

Posted on June 1, 2011 @ 09:45 am

Evotec AG has acquired Galapagos NV’s Compound Focus, Inc., the compound management business of the Galapagos company BioFocus, for $14.7 million in cash, with an additional $3.2 million in potential milestones.

Compound Focus, Inc. is based in South San Francisco and is a leader in small molecule compound management services. The company’s technologies are focused on automated storage and custom design solutions for small molecule drugs. This acquisition augments Evotec’s early drug discovery services, adds to its existing compound management offering, and adds revenues.

Dr. Werner Lanthaler, chief executive officer of Evotec, said, “This acquisition will substantially improve our ability to support our alliance partners in developing and managing their compound libraries. The link to our industry leading screening platform further strengthens our hit identification capabilities. In addition, the profitable revenues shown by Compound Focus over the last years will further enhance our earnings profile going forward.”

Onno van de Stolpe, chief executive officer of Galapagos, said, “This transaction enables us to concentrate on what we do best in BioFocus and Argenta, providing top-class drug discovery solutions needed to deliver molecules for our customers. Compound management is not strategic to our offering. We are pleased to have found a good home for Compound Focus and wish them continued success as part of Evotec.”

LabCorp To Acquire Clearstone Central Labs

Posted on June 1, 2011 @ 09:43 am

Laboratory Corporation of America Holdings (LabCorp) has entered into a definitive agreement to acquire Clearstone Central Laboratories, a global provider of central lab services for late-stage clinical trials. The transaction, subject to customary closing conditions, is expected to close 2Q11. Terms of the agreement were not disclosed.

The acquisition provides LabCorp with a global network of central labs and Clearstone’s clinical trials management system, APOLLO CLPM, which provides realtime access to global data, chain of custody, automated sample stability monitoring, and consistency across all lab sites. The combined company will have the largest available biomarker assay portfolio with globally harmonized and testing platforms in areas such as pharmacogenomics, microbiology, immunohistochemistry, allergy testing, cytogenetics and flow cytometry.

“This acquisition fully combines the complementary strengths of the Clearstone and LabCorp clinical trials businesses to support drug development,” said David P. King, chairman and chief executive officer of LabCorp. “This transaction is an important milestone as it extends our global footprint and service capabilities in key geographies such as Asia Pacific, and advances the company’s companion diagnostics and personalized medicine strategy.”
Executive Moves: Jubilant HollisterStier

Posted on June 1, 2011 @ 09:41 am

David A. Linn has been named director of business intelligence and business development for Jubilant HollisterStier’s Contract Manufacturing & Services Division.

Mr. Linn joins the company from DSM Pharmaceuticals, where he served in various marketing and sales positions during the past 10 years. Most recently, he was senior director of marketing and business development responsible for advertising, promotion and market intelligence activities for DSM’s Finished Dosage Form business. He also has more than seven years of experience at DSM in account management, and was the global project manager for two corporate-level teams focused on business process improvement and CRM implementation. Prior to DSM, Mr. Linn was a project manager at Bausch & Lomb Pharmaceuticals.

“I am excited to have David join our team and look forward using his insight and industry experience to help us expand Jubilant HollisterStier’s contract manufacturing reach,” said Curtis Gingles, vice president of marketing and sales, Jubilant HollisterStier.
PPD Awarded U.S. Army Contract

Posted on June 1, 2011 @ 09:40 am

PPD, Inc. has been awarded the U.S. Army Medical Research Acquisition Activity: Regulatory Affairs & Compliance Support contract to provide global regulatory and biostatistic services for a range of U.S. Army funded clinical development programs. The multi-year, indefinite delivery, indefinite quantity (IDIQ) contract has maximum value of $45.5 million for a five-year period.

PPD will provide regulatory and consulting services to aid the U.S. Army in preparing and filing clinical trial submissions to the FDA and other regulatory authorities worldwide. PPD will support the Army’s biodefense, biopreparedness and vaccine development initiatives aimed at protecting military personnel. PPD will also provide statistical consulting, study design and statistical analysis support.

“This contract enables us to deliver on our breadth of global regulatory and biostatistics services and assist the U.S. Army in advancing clinical programs that improve the health of men and women serving in our armed forces,” said Henrietta Ukwu, M.D., senior vice president of global regulatory affairs for PPD. “We are pleased to partner with the U.S. Army in this effort and to continue to extend our long history of partnering with the U.S. Government on clinical research and development.”
PharmaNet, CITN In Cancer Therapy Pact

Posted on June 1, 2011 @ 09:38 am

PharmaNet Development Group is collaborating with the Cancer Immunotherapy Trials Network (CITN) to help identify trials with immunotherapy agents prioritized by CITN as having high potential for cancer therapy. PharmaNet will focus its expertise in the development of immunotherapies and cancer vaccines to support this initiative.

“We are thrilled to collaborate with the CITN multi-investigator team,” said PharmaNet’s Dr. Anthony Maida, vice president, Clinical Research and general manager, Oncology. “The association allows us to identify oncology centers of excellence and thought leaders to collaborate on the development of cutting-edge therapeutics.”

May 2011

AZ, Heptares in GPCR Pact

Posted on May 31, 2011 @ 08:05 am

AstraZeneca and Heptares Therapeutics have entered a four-year collaboration focused on the potential discovery and development of new medicines targeting G-protein coupled receptors (GPCRs).

GPCRs are among the largest and most important family of proteins found in the human body, yet they become highly unstable when removed from their natural membrane-bound environments. This instability has prevented pharmaceutical researchers from understanding GPCR structures and hampered efforts to design medicines that work on GPCR targets.

This collaboration brings together Heptares' GPCR discovery expertise and proprietary technologies, including its StaR technology, which engineers stabilized receptors allowing GPCRs to be investigated, with AZ's discovery, development and commercial capabilities. Research conducted under the collaboration will focus on a number of specific GPCR targets linked to CNS/pain, CV/metabolic and inflammatory disorders from projects in AZ's small and large molecule portfolio, including projects from its biologics unit, MedImmune. This research will act as the starting point for drug discovery by producing the first-ever stabilized forms of GPCRs in their natural pharmacological conformation.

As part of a joint discovery effort, Heptares and AstraZeneca will engage their respective discovery teams, compound libraries, and other discovery technologies for the purposes of initial screening and lead identification. Results will be combined into a common pool and the best leads will be further optimised collaboratively. AstraZeneca will then select preclinical, small and large molecule candidates and will be solely responsible for preclinical and clinical development.

AstraZeneca has worldwide commercial rights to product candidates emerging from the collaboration. Heptares will receive an upfront $6.25 million cash payment fee, as well as committed research funding. Heptares also qualifies for significant future payments depending on delivery of agreed milestones. Heptares will receive royalties on sales of all products discovered through the joint research.
Radiant Adds Consumer Testing Division

Posted on May 31, 2011 @ 08:01 am

Radiant Research, Inc. has established a new division devoted to consumer trial conduct to expand its consumer products testing capabilities. The company has hired, Charles Folk, a 40-year veteran in the consumer product testing industry, to head up the development of this division. Radiant has also recently added a number of experts to the organization for the evaluation of cumulative irritation and sensitization, malodor and oral care. Radiant is in the process of cross-training and certifying additional personnel to be able to meet the staffing requirements for these types of trials.

“Radiant has a Quality Assurance process that is designed for the rigors of clinical trial conduct. This level of quality has increasingly become a necessity in consumer trials,” said Mr. Folk. “Because Radiant follows the same stringent processes when conducting consumer trials, clients can be assured that their consumer product testing, whether safety or efficacy, will be conducted under the highest standards. Additionally, Radiant has the ideal infrastructure and support services to meet the demands of conducting consumer trials”

According to a company statement, "Radiant has 20 centers throughout the U.S., enabling testing under any climatic conditions required. Radiant’s recruitment infrastructure, consisting of a central Call Center and Media group, can address the very tight recruitment timelines of consumer trials. Radiant will be able to utilize its subject database of over 1 million subjects to meet these timelines. Radiant will leverage the expertise of its product development consulting division, Radiant Development, in the areas of protocol development, data management and report writing."

Asked why Radiant is focusing in this area, chief executive officer Julie McHugh commented, “In addition to consumer and nutritional companies looking to enhance and expand their product portfolios through well-established safety and efficacy claims, Radiant is working with Big Pharma companies who are increasingly looking at consumer products to replace diminishing portfolios due to impending patent cliffs. The Pfizer/Wyeth and Merck/Schering-Plough mega mergers, as well as the purchase of Chattem by Sanofi, and the joint venture between Procter & Gamble and Teva, all provide opportunities for these companies to claim a larger stake in the consumer products market. Rigorous scientific testing is essential in generating advertising claims. These claims can greatly enhance the market potential associated with consumer products.”
Executive Moves: Selcia

Posted on May 31, 2011 @ 07:54 am

Simon Bury has been named business development director of the Discovery division of Selcia Ltd. Mr. Bury will lead expansion plans in the company's drug discovery offering.

Mr. Bury has more than 30 years of commercial experience within the life sciences industry, with a strong mix of technical, strategic and business development expertise. He was most recently chief commercial officer for Cyprotex Discovery Ltd., where he was responsible for the company’s global sales and marketing activities. Prior to Cyprotex, Mr. Bury held senior business development roles at Shanghai ChemPartner, Scottish Biomedical, Pharmacopeia, Hewlett-Packard and Zymark.

Simon Saxby, chief executive officer of Selcia, said, “We are delighted to welcome Simon Bury to Selcia Discovery’s rapidly expanding team. We look forward to Simon helping us develop our integrated drug Discovery division, and accelerate our growth into this strategic area, complementing our other world leading contract research services.”

On joining Selcia, Mr. Bury commented, “Selcia Discovery has established a fabulous reputation for delivering high quality integrated drug discovery services to the global pharmaceutical and biotechnology industry. I am very much looking forward to using my experience to further advance this business.”
Evotec Receives Boehringer Milestone

Posted on May 31, 2011 @ 07:50 am

Evotec AG has received a milestone payment of $2.8 million from Boehringer Ingelheim after a back-up compound in their strategic alliance advanced into a Phase I trial. The compound, which was discovered and optimized within the alliance, is being developed as a novel treatment for neuropathic pain.

The alliance has involved working on multiple high priority targets across key therapeutic areas. So far it has resulted in 13 milestone payments from multiple programs. Dr Werner Lanthaler, chief executive officer of Evotec, remarked, "New more effective treatments against pain are urgently needed. We continue to enjoy a rewarding partnership at both scientific and commercial levels with Boehringer Ingelheim."

The companies began their collaboration In 2004, to jointly identify and develop preclinical development candidates for the treatment of various disease areas including CNS, inflammation, cardiometabolic and respiratory diseases. In 2009, the collaboration was extended for an additional four years and the scope expanded to include oncology targets. BI has full ownership and global responsibility for clinical development, manufacturing and commercialization of the compounds identified. In return, Evotec receives ongoing research payments and preclinical milestones. The contract also provides substantial long-term upside for Evotec through potential payments for successful milestone achievements during clinical development and royalties when new drugs reach the market.
Amarin Builds Global Supply Network for AMR101

Posted on May 31, 2011 @ 07:45 am

Amarin Corp. has expanded its supply network for AMR101 through the addition of two API suppliers and two encapsulators. Equateq Ltd. and Chemport Inc. have agreed to provide Amarin with API, while Catalent Pharma Solutions and Banner Pharmacaps Europe will provide soft-gel encapsulation services. These agreements expand Amarin's entire supply chain and provide the company with significantly greater global capacity and diversification in preparation for the commercial launch of AMR101.

AMR101 is a prescription-grade omega-3 fatty acid that Amarin is developing as a potentially best-in-class prescription medicine for the treatment of patients with very high triglyceride levels (>500 mg/dL) and as a potentially first-in-class therapy for patients with high triglyceride levels (>200 and <500mg/dL) who are also on statin therapy for elevated LDL-cholesterol levels.

Joseph Zakrzewski, Amarin's executive chairman and chief executive officer, stated, "A primary 2011 goal for Amarin is to expand our global supply chain to support expected product demand, diversify our supply base and ensure cost-efficient supply. Positive clinical trial results heightened the timing and urgency of achieving that goal. We believe that the addition of these suppliers position us, subject to regulatory approval, for an aggressive launch of AMR101."

Equateq, based in Scotland, and Chemport, based in South Korea, are companies with substantial expertise in manufacturing polyunsaturated fatty acids for use in both pharmaceutical and nutraceutical products. Amarin has used Banner for encapsulation services for many years, including encapsulation for all of AMR101's clinical trials.

Amarin's current plan, subject to 3Q11 submission and subsequent approval of an NDA, is to launch AMR101 based on product produced by its existing API supplier. The company has created a protocol, with feedback from regulatory authorities, for the qualification of additional API suppliers. The company's aim is for Equateq and Chemport to complete all necessary qualification steps needed to facilitate the submission of a supplemental NDA promptly upon any approval of the NDA.

As part of the API agreements, Amarin is obligated to make minimum annual purchases from Equateq ranging from approximately $10 to $20 million. In addition, Amarin has agreed payEquateq a one-time commitment payment of $1.0, development fees up as much as $0.5 million, as payment as high as $5.0 million for purchasing initial raw materials to be credited against future API purchases. The company is obligated to make minimum annual purchases from Chemport ranging from approximately $7.5 to $15 million. Amarin agreed to make a minority share equity investment in Chemport of up to $3.3 million.

No lump-sum or minimum dollar amount payments are required in the terms with which the company has agreed with Catalent and Banner.
BioStorage Opens New Biorepository

Posted on May 27, 2011 @ 08:46 am

BioStorage Technologies has opened its new 60,000-sq.-ft. biorepository facility in Indianapolis, IN. The facility is dedicated to the preparation, storage and cold-chain transport of human biological samples for a variety of customers, including academic centers, CROs, donor programs and biotechnology companies.

“BioStorage Technologies is committed to its investment in comprehensive sample management solutions, and this new facility provides the company with the infrastructure needed to support our continued growth and expanded services,” said Greg Swanberg, chief executive officer of BioStorage Technologies.

The expansion allows BioStorage to offer sample preparation services, including automated liquid handling technology for high-throughput DNA and RNA extraction and verification. Once samples are processed, aliquots of blood and/or DNA products can be retrieved and scheduled for transport to research testing sites using the company’s tracking and inventory management system, ISISS.

Storage options available at the facility include: automated carousel controlled-room temperature storage at 15ºC to 27ºC, bulk sample storage at 15ºC to 27ºC, walk-in cold sample storage -20ºC to 5ºC, ultra-low temperature storage -70°C to -80°C, and -190ºC vapor phase liquid nitrogen. BioStorage Technologies maintains FDA 21 CFR Part 11 validated technology systems and adheres to FDA regulations, as well as U.S. Department of Transportation and International Air Transport Association guidelines.
SCM To Manufacture Onco-Drug for SEP

Posted on May 27, 2011 @ 08:44 am

Speciality European Pharma (SEP) and SCM Pharma have entered a manufacturing development agreement for the development and validation of the manufacturing and product testing processes at SCM’s UK-based facility. SEP initiated the transfer of the commercial supply of its oncology product Plenaxis to SCM Pharma. Once the development is complete, SCM is expected to be the exclusive production partner for the vial filling of SEP’s hormonal product for the treatment of advanced and metastatic prostate cancer. SCM will then supply the licensed product in Germany and across Europe. The product is a highly potent dry powder substance that will be filled in a highly contained environment and presented in terminally sterilized vial.

Tim Record, vice president of operations at Speciality European Pharma, said, “SCM Pharma has an excellent reputation in the industry and high quality standards, which makes them an ideal partner for a specialist pharma company such as SEP. We feel SCM has the right facilities, expertise and approach to meet our current and forecasted product supply needs and we look forward to building a long-term relationship with them.”

Dianne Sharp, managing director at SCM Pharma, commented, “The project with SEP is a real milestone for our business in that it should lead to the securing of another long-term commercial contract and also further reinforces our position of assisting pharmaceutical companies developing or requiring supply of cancer products.”
Pharmascience Acquires Aegera

Posted on May 27, 2011 @ 08:42 am

Pharmascience, a generic pharmaceutical company basin in Quebec, has acquired Aegera Therapeutics, a Montreal-based clinical-stage biotechnology company focused on developing therapeutics to address unmet medical needs, primarily in oncology. Aegera’s 20 employees will join Pharmascience.

“The acquisition of Aegera will enable Pharmascience to increase and diversify its research and development activities through the continuance of Aegera’s programs,” said David Goodman, chief executive officer of Pharmascience. This acquisition will strengthen Pharmascience’s position as a pharmaceutical leader, and will solidify our organization’s diversification and expansion strategy.”
Executive Moves: SARmont

Posted on May 27, 2011 @ 08:38 am

Dr. John Talley has been appointed chief scientific officer of SARmont, a provider of medicinal chemistry services. Dr. Talley will oversee all drug design and optimization projects for clients to identify high quality and proprietary investigational new drug (IND) lead candidates. Randy Weiss will serve as SARmont’s first president and chief executive officer.

“SARmont partners with pharmaceutical companies, venture capital firms and research institutions to help bring promising new drugs to the market,” said Dr. Talley. “By helping our clients overcome obstacles of preclinical pharmaceutical research, we increase the probability of success.”

SARmont provides drug design and lead optimization services to help clients streamline and accelerate the drug design process. SARmont’s management team also includes Dr. Eduardo Martinez, director of operations, and Dr. Rick Ryan, president of business development.

“SARmont is a trusted strategic partner that provides medicinal chemistry design and lead optimization services that put the focus on efficient and cost-effective success,” said Dr. Ryan. “In an increasingly competitive market, our unique partnership approach ensures that SARmont clients own any intellectual property that’s generated to help them institutionalize that knowledge, and we help develop the IP strategy.”

Pfizer Selects PAREXEL, ICON As Strategic Partners

Posted on May 26, 2011 @ 09:36 am

Pfizer has selected PAREXEL International and ICON plc as preferred providers for clinical trial services. PAREXEL will work with Pfizer under a five-year agreement to provide clinical development services and expertise on a global basis combined with its eClinical technology platform.

Under the partnership agreement with ICON, Pfizer will leverage ICON’s expertise in the areas of program initiation and management, site and country feasibility, data management and reporting set-up, program study drug logistics, scientific and medical communications, and quality assurance. Pfizer will retain scientific ownership of the clinical development process, and maintain oversight and quality standards relating to patient safety and regulatory compliance. Both partnership models will be implemented over an 18-24 month period beginning in June 2011.

“This new strategic partnership model is part of a comprehensive program to sharpen our research focus at Pfizer, and creates a more flexible cost base through outsourcing of certain R&D services. We are creating partnerships for activities that can be performed most effectively and efficiently outside of the company, and have selected PAREXEL because it is a leader in providing combined technology and clinical capabilities,” said John Hubbard, senior vice president, Worldwide Development, Pfizer.

“We look forward to providing innovative solutions and expertise to help Pfizer accelerate clinical trials and accomplish its development goals. PAREXEL is proud to be selected as a strategic partner and will work collaboratively with Pfizer to create significant value,” said Josef von Rickenbach, chairman and chief executive officer, PAREXEL. “We are focused on applying best-practice operational models, supported by a combination of our eClinical solutions and clinical processes, to help Pfizer reduce the time and cost of development. Leveraging our global resources and worldwide technology infrastructure, we can enable more effective information flow and improve data access, which results in greater visibility into trials — and ultimately in better decision making.”

Peter Gray, chief executive officer at ICON, said, “This announcement is another significant indicator of ICON’s ability to partner with major companies in helping them transform their drug development model and validates the investments that we are making to capitalize on the changing market environment. We look forward to working with Pfizer to help realize their development pipeline and expect that over time our partnership will have a significant positive impact on ICON’s future growth.”

Johnson & Johnson Highlights Growth Strategy

Posted on May 26, 2011 @ 09:33 am

Johnson & Johnson will review growth strategies for its Pharmaceuticals business and address therapeutic area strategy, advancing key compounds in its pipeline, and leveraging global market strategies to grow market share and expand geographic presence. J&J plans to continue to address and build on five therapeutic areas: neuroscience, cardiovascular and metabolism, immunology, oncology and infectious diseases/vaccines.

"Our people focus every day on addressing the world's major unmet medical needs with superior science," said vice chairman, executive committee, Sheri McCoy. "Since our last Pharmaceuticals Business Review with analysts in 2009, we have built a highly productive pharmaceuticals pipeline, with six key new products launching and another two pending regulatory review, some in multiple geographies. Our disciplined approach to R&D, rigorous investment prioritization, and internal and external sources of innovation, have enabled us to be well-positioned for long-term growth.Our revitalized portfolio and launch capabilities have led to market leadership in key categories."

The company’s four strategies to grow its pharmaceuticals business include:
  • focusing on differentiated medicines by expanding in immunology, oncology and vaccines,
  • prioritizing investments in internal R&D, strategic licensing, partnerships and select acquisitions to build a robust pipeline for the long-term,
  • strengthening its geographic presence and increase investments in emerging markets, as well as remain focused on key developed markets, particularly Japan,
  • investing in talent and organizational capabilities locally, regionally and globally, building R&D capabilities in new technology areas and emerging markets.
J&J's pharmaceuticals business invested approximately $4.4 billion in R&D programs last year. Paul Stoffels, M.D., worldwide chairman, Pharmaceuticals, said, "Innovation and sustained R&D productivity are key to our long-term future. The future drivers for success in pharmaceuticals will depend on matching the medical need with the best science and operational excellence. Our development programs incorporate an outcomes-based approach, embedding customer, physician, and patient insights, while our broad-based expertise and global development operations allow us to deliver competitive products globally, with enhanced productivity and accelerated timelines."
PharmaNet, HMR in Renal PK Pact

Posted on May 26, 2011 @ 09:32 am

PharmaNet Development Group’s subsidiary, PharmaNet Canada, Inc. and Maisonneuve-Rosemont Hospital (HMR) and its Research Center, have agreed to collaborate in the conduct of pharmacokinetic studies in patients with impaired renal function.

PharmaNet's clinical pharmacology unit in Canada evaluates new drugs in Phase I studies for its clients. Under the current FDA draft guidance, certain studies require the evaluation of drug products in study participants that have impaired renal function. The collaboration with HMR will provide PharmaNet with enhanced access to potential study participants with mild, moderate, or severe impaired renal function.

"We are very pleased to partner with HMR," said Riaz Bandali, president, Early Stage Development. "Demand for the conduct of pharmacokinetic studies in patients with impaired renal function is increasing. By partnering with HMR, a leading nephrology center and specialized hospital, we can efficiently conduct trials in patients with various levels of renal impairment, while assuring the patients' safety and well-being.”

"By partnering with PharmaNet, our renal impaired patients have the opportunity to contribute to the evaluation of innovative, potentially life-saving therapeutics in a safe environment with their own physicians," said Dr. Vincent Pichette, Nephrologist-Pharmacologist and Director of the Nephrology Research, Maisonneuve-Rosemont Hospital.
Labtec Opens GMP Facility in Germany

Posted on May 26, 2011 @ 09:30 am

Labtec GmbH, a subsidiary of tesa SE, has opened its new GMP manufacturing facility for transdermal drug delivery systems (TDS) and oral dispersible films (ODF) employing its RapidFilm technology. The facility is located within tesa’s largest manufacturing site, tesa Werk Hamburg GmbH, south of Hamburg, Germany. The production facility provides for industrial mass production and includes coating and drying lines with variable coating widths. The facility has modern slitting machinery and high-precision, flexible converting and packaging equipment dedicated to TDS and ODF. The plant operates with a clean-room environment and is GMP compliant.

Ingo Lehrke, managing director at Labtec said, “It took only one and a half years from the initial planning phase until completion of construction and start of operation of the unit. This quick implementation is the result of an extremely close and dedicated cooperation between experts from tesa, Beiersdorf and Labtec. We are now able to combine Labtec’s pharmaceutical know-how with tesa’s extensive manufacturing expertise to supply our customers with innovative drug delivery products.”
Executive Moves: Marken

Posted on May 25, 2011 @ 08:38 am

Wesley P. Wheeler, MBA has been named chief executive officer of Marken. He succeeds Gerard Barba, who will remain the chairman of the board.

"As the nature of biopharmaceutical R&D changes, well controlled clinical supply chains will be a significant factor in the success of key life science companies and the industries that support them. The Board and I feel that Wes can bring his experience from the drug manufacturing, biotechnology and traditional pharmaceutical industries to augment an already strong management team and continue Marken's growth," said Mr. Barba.

Prior to joining Marken, Mr. Wheeler was president and chief executive officer of Patheon. He was also a former president of Valeant Pharmaceuticals International, and previously held senior executive roles of increasing responsibility in manufacturing, marketing and engineering at GlaxoSmithKline. Preceding his 22-year career in pharmaceuticals, Mr. Wheeler had a successful 12-year career at ExxonMobil. Mr. Wheeler has also contributed several columns and articles to Contract Pharma and is a member of the Contracting & Outsourcing Conference Advisory Board.

Mr. Khawar Mann, managing partner at APAX LLP., which owns Marken, said, "We are delighted that Wes has agreed to join us at Marken. His operations background and successful track record in the pharmaceutical industry will give us the tools we need to continue building Marken's portfolio of services and geographies, and thus realize our greatest potential as a leading logistics services provider."
AMRI Gains Phase II Milestone from BMS

Posted on May 25, 2011 @ 07:54 am

AMRI will receive a $3 million milestone payment from Bristol-Myers Squibb resulting from a recently initiated Phase II clinical trial of an AMRI compound exclusively licensed to BMS.

This is the sixth milestone payment originating from a 2005 agreement in which AMRI licensed to BMS its technology around CNS triple reuptake transporter inhibitors as potential improved treatments for depression and CNS diseases. This payment brings the total milestone and licensing fees earned by AMRI related to the license agreement to $22.75 million. AMRI has also received $10 million in research collaboration fees under the agreement. In addition to the compound entering Phase II clinical evaluation, BMS is continuing to evaluate other collaboration compounds for depression and other indications.

AMRI is eligible to receive as much as $66 million in development and regulatory milestone payments per compound for the first two compounds and payments of as much as $22 million per compound on subsequent compounds. AMRI also will receive royalties on worldwide sales of any commercialized compounds.
SCHOTT Launches Packaging Site in Russia

Posted on May 25, 2011 @ 05:52 am

SCHOTT has inaugurated a primary pharmaceutical packaging production site in Zavolzhe, near the Russian city of Nizhny Novgorod. The new production site will employ approximately 60 employees initially and will produce premium quality ampoules and vials.

“We are the first international group which manufactures primary pharmaceutical packaging made of glass to open a production facility in Russia,” said Professor Dr. Udo Ungeheuer, chairman of SCHOTT AG, at the plant inauguration. “With this new plant, we are further expanding our position as the leading supplier to the pharmaceutical industry in Russia.”

SCHOTT Pharmaceutical Systems supplies glass tubing and primary packaging for the pharmaceutical industry. The company has been selling ampoules, vials, cartridges and syringes to the Russian market already since the beginning of the 1990s. Until now, Russian customers have been mainly supplied from SCHOTT's existing pharmaceutical packaging site in Hungary.

“With our new facility in Zavolzhe, we are able to satisfy local demands even better than before,” said Dr. Juergen Sackhoff, executive vice president of SCHOTT Pharmaceutical Systems.

The new plant for primary pharmaceutical packaging is the company's second production site in Russia. The company already runs a flat glass processing plant in Bor, near the city of Nizhny Novgorod, that supplies the household appliance industry. SCHOTT established a delegate office in Moscow, the Russian capital, in 1995.
PsychoGenics, Evotec To Work on CNS Drugs

Posted on May 25, 2011 @ 05:47 am

PsychoGenics and Evotec AG have entered into a strategic alliance to provide integrated CNS drug discovery solutions to pharmaceutical and biotech companies. The two companies will work together to provide existing and new clients access to their complementary drug discovery platforms for the identification and development of new therapeutics to treat CNS disorders.

PsychoGenics' proprietary behavioral testing platforms are used for the characterization of drugs, the phenotyping of disease models and the multi-dimensional testing of drugs in disease models. Evotec offers an advanced technology platform, a broad range of integrated capabilities and therapeutic area expertise in metabolic disease, CNS, pain, inflammation and oncology.

Dr. Mario Polywka, Evotec's chief operating officer, said “By bringing together the industry-leading CNS drug discovery platforms of Evotec and PsychoGenics, our clients and partners will benefit through an increased probability of success and faster and more informed decision making in their drug discovery efforts with the goal of delivering preclinical candidates in the most time and cost efficient manner.”

Dr Emer Leahy, PsychoGenics' president and chief executive officer, added, “We are delighted to enter into this collaboration with Evotec, an innovative leader in drug discovery. PsychoGenics and Evotec each have a long-standing history of successful partnerships in which they share discovery risk with pharmaceutical companies, and have delivered several pre-clinical candidates. Now, by combining forces, partners have the opportunity to avail themselves of fully-integrated and proprietary capabilities to drive and transform their CNS discovery programs and lower their overall risk."
Avecia Launches Process Development Program

Posted on May 25, 2011 @ 05:41 am

Avecia Biotechnology has launched of its OliGO- Faster, Smarter, BetterSM development program. The program "formalizes Avecia’s extensive process knowledge into an easily accessible parameter library," according to a company statement.

OliGO is pre-designed to provide a streamlined path from development to cGMP manufacturing; the program aligns small scale models with production capabilities to minimize risk and increase cost efficiencies. Combined with Avecia’s small and intermediate pre-clinical production capabilities, OliGO offers a cost effective and well tested route to quickly deliver non-cGMP material, said the company. The OliGO parameters can also be used as an advanced starting point for development activities, providing clients with the opportunity to bypass initial development work, and move directly to fine tuning a process for optimal purity and yield.

According to a company statement, "Avecia maintains the world’s largest library of oligo process and manufacturing data at scale, drawing from nearly 20 years of experience. Teams of engineers, development chemists, and manufacturing experts have worked together to identify the very best of the process parameters for all our oligo classes, and to formalize them into our OliGO advanced development program."

Dr. Emma Wright, Avecia's senior director Process Development, remarked, “Avecia’s process development team is pleased to offer OliGO in conjunction with their extensive service portfolio, including the tech transfer of sequences at all phases of development- from pre-clinical to approved commercial oligonucleotide therapeutics.”
Proteostasis, Elan in Discovery Pact

Posted on May 25, 2011 @ 05:27 am

Proteostasis Therapeutics and Elan Corp. have formed a strategic business relationship to advance Proteostasis’ platform for the discovery and development of disease-modifying, small molecule drugs and diagnostics for the treatment of neurodegenerative disorders such as Parkinson’s, Huntington’s, multiple sclerosis and amyotrophic lateral sclerosis (ALS), and a broad array of dementia-related diseases including Alzheimer’s. This innovative initiative will combine Proteostasis’ discovery technology, novel targets and compounds that modulate key Proteostasis Network pathways with Elan’s strength in proprietary animal models, biology, medicinal chemistry and clinical development.

Elan has invested $20 million into equity capital of Proteostasis and will have an opportunity to provide an additional $30 million in collaboration funding over five years. As part of the agreement, Elan will become an approximate 24% shareholder in Proteostasis, has obtained a right of first negotiation to exclusively license compounds emerging from the combined initiative, and will have the right to a seat on the Proteostasis board of directors as well as its scientific advisory board. By mutual agreement, this innovative relationship can be extended for a further five years.

Peter Reinhart, Ph.D., president and chief scientific officer of Proteostasis, commented, “We are excited to announce this promising collaboration with Elan, a proven leader in innovative neurodegenerative disease drug development. This alliance recognizes our progress to date and provides an opportunity to further advance Proteostasis’ novel drug discovery platform. Elan’s proprietary disease models and development expertise will enable us to accelerate our programs, each of which has the potential for developing therapeutics to treat multiple neurodegenerative diseases.”

Kelly Martin, Elan's chief executive officer, added, “This initiative with Proteostasis reinforces our commitment and strategic business objective of being an exceptionally high-caliber, science-driven company and provides a multitude of opportunities for Elan to advance its position as a world leader in the broad field of neuroscience. Importantly, and given the construct of the deal as a capital investment, this transaction is being consummated in a manner that will have a minimal near-term financial impact on our income statement and enable shareholders to realize the benefits of the operating leverage, embedded into our business, that combines expected double-digit revenue growth with a stable and well defined overall cost structure.”
Lilly Forms Critical Care Company

Posted on May 24, 2011 @ 09:22 am

Eli Lilly and Co. has signed agreements with private investors Care Capital and NovaQuest Capital to establish BioCritica, Inc., a new, privately held biotechnology company. Based in central Indiana, BioCritica will initially focus on the continued U.S. development and commercialization of Lilly's severe sepsis drug Xigris, with plans to build a portfolio of hospital-based critical care medicines.

BioCritica will acquire rights to Xigris the U.S. and will receive the rights to potentially acquire several of Lilly’s critical care compounds in preclinical development. The collaboration also includes a supply and services agreement, as well as an option for BioCritica to potentially acquire the rights to Xigris outside the U.S. Lilly will receive royalties on future U.S. sales of Xigris and will also receive an equity stake in BioCritica. Financial terms were not disclosed.

"We are pleased to announce the formation of a new life sciences company in Central Indiana, BioCritica. The collaboration between Lilly and BioCritica will benefit both companies, as well as the patients we serve and the Indianapolis community in which we operate," said John C. Lechleiter, Ph.D., Lilly president, chairman and chief executive officer. "We are confident that BioCritica will help realize the full potential for Xigris, while working to develop new critical care medicines. We look forward to working with BioCritica to help ensure its success."

"For severe sepsis patients, Xigris is an important life-saving drug," said David Broecker, chief executive officer of BioCritica. "Each year more than 200,000 people die from severe sepsis in the U.S. We look forward to building a company dedicated to saving lives. We also appreciate the support of Lilly, the IEDC, and BioCrossroads in helping us get established here in Indiana."

ICON Central Labs Launches Cytometry Services

Posted on May 24, 2011 @ 09:20 am

ICON has launched cytometry services from its Central Laboratories business unit to support the testing requirements and development phase ofcompounds. Global flow cytometry services will be offered from ICON Central Labs in New York, Dublin, Bangalore and Singapore.

ICON Cytometry Services allow clients to collaborate with ICON at the early stages of development to create compound-specific assays and to work with ICON Central Labs’ R&D team to develop flow cytometry methodology, customized SOPs and other special requirements, including reporting. The customized flow cytometry panels can then be used throughout the compound development. Clients will also be able to choose from a wide range of validated assays, often suited to large-scale, high-volume requirements of later phase global trials.

Tom O’Leary, president, ICON Central Laboratories, said, “Flow Cytometry has become a preferred testing method for many of our clients, particularly those with autoimmune, oncology and immunodeficiency compounds that require more specialized testing. Our new Cytometry Services offering provides clients with a better range of options, all of which are supported by a team of highly experienced scientists, robust instrumentation and rigorous quality control systems.”
Xcellerex, Gallus In Biomanufacturing Pact

Posted on May 24, 2011 @ 09:16 am

Xcellerex, Inc. and Gallus BioPharmaceuticals, LLC have entered into a collaboration to provide Gallus with expanded cGMP biomanufacturing capacity using Xcellerex’s FlexFactory GMP manufacturing platform suite. The collaboration provides Gallus with scalable manufacturing and lab technology to expand its contract manufacturing business. This partnership will also provide Xcellerex customers with access to Gallus’ commercial, FDA-approved, biomanufacturing facility in St. Louis, MO.

Under the agreement, Gallus is acquiring several Xcellerex bioproduction systems for new suites and labs at its existing manufacturing facility. Gallus is also acquiring small-scale 10L bioreactors and a FlexFactory cGMP manufacturing line with XDR single-use bioreactors as large as 2000 liter scale for clinical supply. The two companies will provide their customers with access to Gallus’ biomanufacturing expertise and facility.

“Gallus has a unique contract manufacturing business model that enables us to respond to clients’ changing capacity needs quickly, and achieve rapid, high quality production at a competitive price,” said Mark Bamforth, president and chief executive officer of Gallus. “The partnership with Xcellerex allows us to leverage their single-use biomanufacturing platform. This is a strategic investment that rapidly provides us with additional manufacturing capacity and scale-up capabilities to deliver development, clinical and commercial products and services”

Xcellerex chief executive officer Guy Broadbent, said, “Gallus is capitalizing on the extraordinary flexibility afforded by the FlexFactory, along with the extensive manufacturing experience of its team, to provide innovative solutions for established as well as development-stage biopharmaceutical companies. The agreement provides us with an important path to offer full-scale commercial manufacturing to our customers.”
Biologics Process Development Doubles Lab Size

Posted on May 24, 2011 @ 09:13 am

Biologics Process Development, Inc. (BPD), a wholly-owned subsidiary of Viropro, will double the size of its existing bioprocess and scale-up lab in Poway, CA. The expansion will enable the company to provide larger processing volumes. BPD provides contract lab services for the biopharmaceutical industry and specializes in molecular biology, recombinant protein expression, cell culture, bacterial fermentation, protein separation and purification, and frozen cell/material storage.

The company has also appointed Dr. Howard Levine and Dr. Pete M. Fernandes to its Scientific Advisory Board. Dr. Levine has over 30 years of experience in successful product companies and as founder of BioProcess Technology Consultants, Inc. He also served as vice president of manufacturing operations at Repligen Corp. and director of Pilot Plant Operations at Xoma Corp.

Dr. Fernandes has more than 30 years of experience in technical and strategic management of both early and late stage drug development of both recombinant-derived biologicals and of small molecules. Dr. Fernandes recently served as vice president, Pharmaceutical Development, US/EU Operations for Santen, Inc. and vice president and director of Process Development and Strategy at Chiron Corp.
Executive Moves: Harmony Labs

Posted on May 24, 2011 @ 09:11 am

John Simonick has been appointed vice president of quality at Harmony Labs. Mr. Simonick will lead the quality organization including quality control, quality systems and quality engineering. Most recently he served as executive director of quality operations at Watson Pharmaceuticals, where he was responsible for all quality and risk based decisions. He also served as vice president of quality systems for Mission Pharmacal and DPT Laboratories. He has 30 years of experience serving in progressive leadership roles assuming the responsibility for quality assurance, systems, validation, and quality control functions.
Executive Moves: Quintiles

Posted on May 23, 2011 @ 09:53 am

Frederic “Rick” Sax has been named senior vice president and global head of the Integrated Clinical Services division at Quintiles. He is responsible for the business lines that comprise Integrated Clinical Services, including Central Laboratory, Cardiac Safety, Biostatistics, Regulatory Affairs, Medical Writing and Lifecycle Safety Services.

“Rick’s deep and broad experience in biopharma gives him a solid understanding of the challenges that our customers face in the New Health,” said Paula Brown Stafford, president of Quintiles Clinical Development. “He will help our customers navigate challenges and seize opportunities through the delivery of integrated clinical trial services that help customers reduce overall study costs, proactively manage quality, simplify trial management and accelerate development.”

Dr. Sax has nearly 20 years of experience in the biopharmaceutical industry. Most recently he served as vice president of Clinical Design Strategies for AstraZeneca, leading the design of solutions to enhance the quality of program and trial design while driving efficiencies in cost, time and process. He has held executive-level positions at both AstraZeneca and Merck Research Laboratories, where he managed the successful development and registration of new therapies. Prior to joining the biopharmaceutical industry, Dr. Sax served as an academic cardiologist.
Par To Acquire Edict

Posted on May 23, 2011 @ 09:18 am

Par Pharmaceutical Companies will acquire Edict Pharmaceuticals, a generics company based in India, for as much as $37.6 million in cash and the repayment of certain additional debt. The acquisition, subject to customary closing conditions, is expected to be complete by the end of the year.

Edict Pharmaceuticals develops and manufactures solid oral dosage generic pharmaceuticals. The company currently has seven ANDAs filed with the FDA and one ANDA filed in the name of a development partner, and an additional 14 products in development.

Paul V. Campanelli, president of Par Pharmaceutical, said, “This transaction enhances Par’s already successful research and development infrastructure and demonstrates Par’s intention to continue to build out our product development platform. Also, Edict’s facility adds significant operational capacity and provides business continuity protection for our Spring Valley, NY facility.”

Advion Opens Midwest Center of Excellence

Posted on May 23, 2011 @ 09:17 am

Advion BioServices, a subsidiary of Advion BioSciences, Inc., has opened its new 22,000-sq.-ft. Drug Discovery and Metabolism bioanalytical lab in Indianapolis, IN. This expansion was in response to increased demand for metabolism, ADME screening and other early-stage bioanalytical services, as well as to build upon local partnership in the Indianapolis area.

The new facility will focus on the earlier stage, drug discovery and metabolism bioanalytical services required for the preparation of a molecule’s entry into clinical testing. The site is located in the Purdue Research Park of Indianapolis’ technology center at the Ameriplex Business Park, and has approximately 50 employees.

“For our existing clients, the additional services offer a broader and more comprehensive approach to utilize early-access scientific knowledge and transfer this to later stage analysis,” said David B. Patteson, Advion’s president and chief executive officer. “This should allow us to offer what the clients want, when they need it, while ensuring the scientific integrity and quality are maintained at Advion’s high standards.”
Almac Opens North American Headquarters

Posted on May 23, 2011 @ 09:16 am

The Almac Group opened its new North American Headquarters in Souderton, PA. The $120 million, 240,000-sq.-ft. headquarters has more than 800 employees and has brought approximately 300 new hires to the greater Philadelphia area.

The new headquarters includes a three-story office and administration building, as well as a building for the production, analysis and distribution of clinical trial supplies. It was designed by Francis Cauffman Architects of Philadelphia and built by Skanska USA. The design aims to maintain sustainability with low greenhouse gas emissions and a full water reclamation program.

Alan Armstrong, Almac’s chief executive officer, said, “Sir Allen McClay once said, ‘If you’re going to launch a big ship, you have to go where the water is deep.’ He loved growth, development, success and quality and we’ll see all of that in this building.”
Executive Moves: Aesica Pharmaceuticals

Posted on May 23, 2011 @ 09:12 am

Joe Zou, currently chief representative of Aesica Pharmaceuticals’ Shanghai office, has been promoted to manage regional sales across Asia. Mr. Zou will contribute to Aesica’s strategy to become a leader in the supply of APIs and Formulated Products. He will work closely with the team at the head office in the UK to increase Aesica’s presence in Asia, particularly in China.

Mr. Zou joined the company in 2008, based in the company’s Shanghai office. Previously he worked for Whytes Chemicals Ltd. as manager of its China office for nine years.

Dr. Alan Raymond, Aesica’s sales and marketing director, said, “We have made no secret of the fact that we wish to expand into Asia and this strategic promotion for Joe Zou will help us to achieve a greater presence in China and beyond. Joe has worked in China for many years, speaks the language, knows the culture and has very strong relationships with a number of contacts across the region. Joe is in a position to forge important relationships for Aesica.”
Executive Moves: Astellas Pharma US, Inc.

Posted on May 20, 2011 @ 09:02 am

Mark Reisenauer has been appointed vice president of sales and marketing, oncology, at Astellas Pharma US, Inc. Mr. Reisenauer will be responsible for all U.S. commercial activities supporting marketed products, the company’s oncology co-promotion partners and will lead commercial planning for early stage development compounds. He reports to Patrick Shea, senior vice president of marketing and sales.

“Astellas has made significant progress over the last year toward becoming a global category leader in oncology with the integration of OSI oncology and further development of the pipeline. Mark’s breadth of product experience, along with his proven leadership capabilities, will be instrumental in Astellas’ future success in oncology,” said Mr. Shea. “We are excited to add Mark to our management team.”

Mr. Reisenauer has more than 20 years of experience having held sales and marketing positions at Abbott, Pharmacia, Bristol-Myers Squibb and Zeneca. Most recently, he served as senior vice president and chief commercial officer of Micromet, Inc., where he was involved in investor and public relations, clinical strategy, business development, and commercial launch planning.
Executive Moves: EMD Serono

Posted on May 20, 2011 @ 09:02 am

Fereydoun Firouz has resigned from his position as president and chief executive officer of EMD Serono, Inc., an affiliate of Merck KGaA. Mr. Firouz has decided to pursue other professional opportunities. James Hoyes, who is currently chief commercial officer at EMD Serono, will serve as acting head an interim basis.

Mr. Firouz began his career with Serono in 1989 as a Government Affairs Associate in the company’s Washington, DC office, progressing into positions of increasing responsibility before taking the role of president and chief executive officer of U.S. operations in March 2003. During his tenure Mr. Firouz tripled the revenues and capabilities of the U.S. organization.

“We would like to thank Fereydoun for his leadership and contributions to the company over the last two decades,” said Stefan Oschmann, president of Merck Serono and a member of the executive board of Merck KGaA. “Fereydoun’s vision has been instrumental in helping us to build a solid U.S. organization, which is well positioned to continue its successful growth in the future.”

Mr. Hoyes has been with the organization for seven years, previously serving as executive vice president of Neurology before moving into his current role. He has more than 25 years of pharmaceutical industry experience, holding senior positions at Elan, Sanofi-Synthelabo, Sanofi, and Sterling Drug.
BioAegis Licenses Protein for Development

Posted on May 20, 2011 @ 09:00 am

BioAegis Therapeutics has entered into an exclusive option agreement with Brigham and Women’s Hospital granting BioAegis a worldwide license for therapeutic and diagnostic use of Brigham’s technology for human and animal applications. The technology is based on the research of founding scientist Dr. Thomas Stossel, director, Translational Medicine at Brigham and Women’s Hospital, and collaborators at Massachusetts General Hospital, University of Pennsylvania, Beth Israel Deaconess Medical Center and BloodCenter of Wisconsin.

Dr. Stossel said, “Plasma gelsolin is just beginning to reveal its fundamental role in immune function and inflammation. BioAegis is committed to a broad set of translational objectives which promise to deliver high value therapeutics to patients.”

Plasma gelsolin is the fourth most prevalent protein in human blood and levels in humans and in animal models are known to be depleted in several acute and chronic diseases. In humans, depletion of pGSN correlates with severity of disease and the relative risk of adverse outcomes. Replacement of depleted pGSN has been shown to prevent adverse outcomes in animal models.
Accovion Expands in UK

Posted on May 20, 2011 @ 08:59 am

Accovion has expanded with a new subsidiary in the UK and has appointed Carl Naraynassamy as managing director. The expansion is part of Accovion’s strategic plan to formalize activities in several European countries by establishing additional subsidiaries and to offer its clients a broader spectrum of country-specific clinical research expertise.

Ivana Waller, Accovion’s chief operating officer, said, “The UK has always represented a key strategic territory for Accovion. In addition, with our increasing regulatory portfolio, our growing involvement in device pharmacovigilance and health economics, it had become imperative for us to be firmly implanted in London. Our new subsidiary consolidates our presence in Europe and affords us a sure platform to access the considerable local clinical research talent and respond even better to our clients’ growing needs.”

“We are very pleased to bring on board an experienced Mr. Naraynassamy, who is well respected for his contributions to the fields of clinical research and pharmaceutical medicine education globally. I am confident that with his vision, business acumen and clinical research expertise, Accovion’s operations in the UK will continue to prosper,” added Ms. Waller.

Accovion supports local and global projects for the pharmaceutical, biotechnology and medical device industries, including project planning and management, clinical trial execution, clinical monitoring, data management, adverse event management including post-marketing surveillance, biostatistics and statistical programming, medical writing and electronic publishing.
Takeda to Acquire Nycomed

Posted on May 19, 2011 @ 09:05 am

Takeda Pharmaceutical Co. Ltd. has reached an agreement to acquire Nycomed for $13.7 billion on a cash-free, debt-free basis. The transaction, subject to antitrust clearance, is expected to be completed within 90 to 120 days, making it a wholly owned subsidiary of Takeda. The purchase would exclude Nycomed's U.S. dermatology business.

Nycomed, headquartered in Zurich, Switzerland, has a diversified product portfolio of both established prescription and OTC products. Its significant business infrastructure in Europe and high-growth emerging markets are expected to enhance Takeda's regulatory development expertise and commercialization capability. The acquisition includes the roflumilast franchise (Daxas in Europe), a treatment for chronic obstructive pulmonary disease (COPD), which is expected to be a major source of revenue growth for Takeda. Takeda will also have an immediate and stable increase in cash flow with Nycomed's more than 2.8 billion Euro in annual revenue.

"Takeda is committed to transforming our organization through the acquisition of Nycomed. Nycomed enables Takeda to maximize the value of our portfolio and gives us an immediate strong presence in the high-growth emerging markets while doubling Takeda's European sales," said Yasuchika Hasegawa, president and chief executive officer of Takeda. "Nycomed's strength in a geographically wide range of markets and its diverse talent base will be a strong driver to helping us realize our important mission of striving toward better health for patients worldwide through leading innovation in medicine."

"The combination of Takeda's successful track record of innovation with Nycomed's efficient commercialization and manufacturing infrastructure will create a global player with a phenomenal ability to bring medicines to patients and healthcare providers around the world," said Hakan Bjorklund, chief executive officer of Nycomed.

Lonza Expands Production Capacity

Posted on May 19, 2011 @ 09:04 am

Lonza is expanding its viral-based therapeutics business with the construction of a new, cGMP clean room at its Houston, TX operations. Construction and validation of the expansion is expected to be complete in early 2012.

The clean room will offer large-scale capacity to support late-stage viral vaccine and gene therapy projects. It will use disposable process systems to support production and fill/finish operations of as many as 2,000 liters. The expansion is part of an effort to reduce clients’ wait times for clean room capacity with the ability to run multiple cGMP operations simultaneously.

“We are very pleased with the growing number of opportunities we are seeing in the viral vaccine and viral vector sector,” said David Enloe, Head of Lonza’s viral-based therapeutics unit. “This investment only furthers our commitment to a leadership position in this exciting space of new therapeutics and vaccines.”
Thermo Fisher to Acquire Phadia

Posted on May 19, 2011 @ 09:03 am

Thermo Fisher Scientific, Inc. has signed a definitive agreement to acquire Phadia, a global allergy and autoimmunity diagnostics firm, from European private equity firm Cinven, for approximately $3.5 billion in cash. The transaction is expected to be completed in 4Q11.

Based in Uppsala, Sweden, Phadia develops, manufactures and markets complete blood-test systems to support the clinical diagnosis and monitoring of allergy and autoimmune diseases. Phadia operates through two leading brands: ImmunoCAP for allergy tests and EliA for autoimmunity tests. The company had 2010 total sales of approximately $525 million and employs 1,500 people globally. Phadia will be part of Thermo Fisher’s Specialty Diagnostics business within its Analytical Technologies Segment.

“The acquisition of Phadia is a major step forward in our strategy to enhance Thermo Fisher’s global presence in specialty diagnostics, one of our key growth platforms,” said Marc N. Casper, president and chief executive officer of Thermo Fisher. “This transaction will provide Thermo Fisher with leading allergy and autoimmunity diagnostic testing technologies that expand our specialty diagnostics offerings. Phadia has significant growth opportunities in the large, under-penetrated U.S. market, and can leverage our strong presence in emerging geographies to further accelerate growth.”

“Thermo Fisher brings Phadia a significant opportunity to grow as part of the world leader in serving science,” said Magnus Lundberg, Phadia’s chief executive officer. “We share a culture of innovation and a strong focus on customers, and I am confident that this is a winning combination for our employees and customers around the world.”
Vyteris Restructures as Specialty CRO

Posted on May 19, 2011 @ 09:00 am

Vyteris, Inc. is realigning the company in an effort to become a diversified specialty CRO. This decision follows on the company’s merger with CRO, MediSync BioServices, Inc. Vyteris will now focus all its efforts on consolidating specialty businesses in the CRO, site management organization (SMO) and related services industry. The company is discontinuing its drug delivery business and plans to sell its active transdermal drug-delivery assets.

Vyteris aims to bring together established and profitable privately held CROs, SMOs and related consulting firms to build a cluster of businesses with complementary specialized services and is pursuing multiple acquisition targets expected to close in 2011 and 2012.

"We are excited to be transforming Vyteris into a leading niche player in the specialty CRO industry by executing our strategy for consolidation, growth and potential profitability in an established industry with exciting growth potential,” said Haro Hartounian, Ph.D., chief executive officer at Vyteris. “Our plan is to acquire small, private CROs with successful track records that lack the capital raising power, business development resources and scale to compete with large CROs. With our entrepreneurial leadership and industry experience, we are confident this strategy will provide Vyteris and its shareholders a significant growth opportunity and value proposition.”
Ravensburg-Area Vetter Facility Takes Shape

Posted on May 19, 2011 @ 08:56 am

Vetter has completed the structural work for its new German facility Ravensburg Vetter West. The structural work on its center for visual inspection and high-bay warehouse for cold-storage and room-temperature products is complete. Interior work and the construction of a power supply system will be finished by late 2011, when operations will begin. The facility will employ more than 230 staff.

The new center for visual inspection and logistics will offer optimized quality control processes and material supply, capable of product delivery around the world. The center will offer advanced-design stability chambers with expanded capacity for long-term stability testing under a range of temperatures. Geothermal energy will be used to regulate temperatures in the high-bay warehouse.

"Our new facility in Erlen reinforces Vetter's position in international markets," says Thomas Otto, Vetter Managing Director. "It combines efficiency and sustainability, and its advanced processes support a high level of product and delivery security. Our investment both in the facility and in renewable energy testifies to our commitment to the region. In Erlen, we are laying important groundwork for Vetter's continuing growth and success on the world market."

Thermo Fisher Acquires Sterilin

Posted on May 18, 2011 @ 08:43 am

Thermo Fisher Scientific, Inc. has acquired Sterilin, Ltd., a provider of single-use plastic products for the microbiology, life sciences and clinical markets. Sterilin, headquartered in South Wales, U.K., has 270 employees and had approximately $35 million in revenues in 2010.

“This acquisition broadens the range of innovative specialty laboratory products we can offer our customers,” said Marc N. Casper, president and chief executive officer of Thermo Fisher Scientific. “It is also consistent with our strategy to leverage our global sales and support organization to give our customers across Europe, Asia-Pacific and North America greater access to these products.”

Sterilin’s portfolio includes quality disposable plastic products used in sample collection, preservation and processing, including a line of tissue culture plastics. The business will be integrated into Thermo Fisher’s Laboratory Products and Services Segment.
Ropack Launches Stickpack Facility

Posted on May 18, 2011 @ 08:42 am

Ropack began stickpack production at its new 15,000-sq.-ft dedicated manufacturing suite. The $9 million facility provides uni-dose packaging of solid oral dosage in four Class 100000 clean rooms, each with low relative humidity (20%), controlled temperature and controlled residual oxygen to 4%.

To ensure product integrity, mechanical rooms are positioned so that there is no interference from outside elements. Also, according to the company, flow of product and personnel assures cleanliness and efficiency and strict procedures and documentation are followed to maintain the highest standards.

“We have taken every step to ensure that our new dedicated suite far exceeds what is available elsewhere to our clients,” said Yves Massicotte, Ropack's president and chief executive officer. “It is our goal to be the top North American facility for stickpack production and packaging of all humidity- and temperature-sensitive products.”

“Stickpacks are a convenient and highly marketable packaging option, so we are enthusiastic about spearheading efforts in North America,” added Paul Dupont, director of business development. “I believe we can provide the pharmaceutical and consumer health-care industries the highest level of quality and efficiency in stickpack packaging.”
Goodwin Biotech, Rafagen In Cell Line Pact

Posted on May 18, 2011 @ 08:40 am

Goodwin Biotechnology, Inc. (GBI) and Rafagen, Inc. have entered a collaboration agreement for cell line engineering and biological contract manufacturing. Terms of the agreement were not disclosed.

"We seek to address unmet needs of patients with inherited and acquired diseases," said Sung Ho Hahm, Ph.D., co-founder, president and chief executive officer of Rafagen. "With Rafagen's proprietary technology platforms, the highest producing cell lines will be established at a fraction of the time currently required. This translates the promise of science into tangible therapies that restore health and save lives."

"By collaborating with Rafagen for cell line engineering, we at GBI can expand our capabilities as a biological contract manufacturing organization and offer one-stop shopping," noted SooYoung Lee, Ph.D., senior vice president at GBI. "This enables our clients to overcome challenging projects by working from their cDNA to develop more robust and high productivity cell lines that will not only scale up with greater efficiency, but by identifying cell lines with the highest level of efficacy, the end product will hopefully optimize patient outcomes."
Executive Moves: Premier Research Group

Posted on May 18, 2011 @ 08:37 am

Ronald Kershner, Ph.D. has been appointed vice president, Biostatistics and Data Operations, North America for Premier Research Group Ltd. Dr. Kershner joins the company from Novella Clinical, and has held positions at AAIPharma, inVentiv Clinical Solutions and Omnicare Research.

Dr. Kershner has a strong background in biostatistics and data management with more than 25 years of experience in all operational aspects of clinical trial planning, execution and delivery. He has worked on more than 24 NDAs in various therapeutic areas and has served on more than 20 Data Monitoring Committees.

“We are very pleased to welcome Ron to Premier Research to manage these key operational groups. He has a significant track record with developing efficient and productive teams producing high-quality, on-time deliverables for sponsors as well as providing strategic consulting services for biostatistical study design and guidance for all phases of clinical trials,” said Krista Armstrong, Ph.D., vice president, North America. “His extensive experience leading biometrics teams makes him a natural fit for our company.”
inVentiv Buys PharmaNet

Posted on May 17, 2011 @ 09:23 am

inVentiv Health, Inc. has signed an agreement to acquire PharmaNet Development Group, Inc. from private equity owner JLL Partners. The transaction is expected to close by June 30, 2011. Financial terms were not disclosed. JLL bought PharmaNet in 2009.

In January 2011, PharmaNet acquired i3, another CRO. After both of those deals close, inVentiv will have 13,000 employees across three divisions: Clinical, Commercial and Consulting. More than 6,000 employees will be in clinical research worldwide, and inVentiv will have presence in nearly 40 countries. The Clinical business will account for approximately $900 million of inVentiv's pro forma $1.7 billion in annual revenues.

"One of our key strategic objectives is to be recognized as the leader in every segment where we serve our clients," said Paul Meister, chief executive officer of inVentiv Health. "The acquisition of PharmaNet positions us among the top global CROs, increasing our capabilities, adding new expertise in every phase of clinical development, and strengthening our impressive client base and strong management team."

An inVentiv spokesman toldContract Pharmathat the core value of the trasnaction is to achieve greater scale, thus only limited redundancies are expected after PharmaNet is integrated.

Jeffrey P. McMullen, president and chief executive officer of PharmaNet, said, "Our team is fully committed to continuing to grow our business and executing on the future opportunities that this combined offering provides to both our customers and employees." Mr. McMullen will lead inVentiv's CRO businesses. He noted that he chose to work with inVentiv because "the organizations share the same client-centric approach and strong therapeutic expertise in oncology, rheumatology and neuroscience, as well as in clinical technologies."

Ramsey A. Frank, a partner of JLL, said, "We are very proud of the significant accomplishments that PharmaNet has achieved. We have worked in close partnership with the company's management team to drive operational efficiencies, outstanding new business momentum and the highest EBITDA levels in the company's history."
Tekmira, BMS Expand LNP Collaboration

Posted on May 17, 2011 @ 09:07 am

Tekmira Pharmaceuticals has expanded its multi-year collaboration with Bristol-Myers Squibb to include newly developed Tekmira proprietary lipid nanoparticle (LNP) formulations for delivery to tumors and other tissues outside the liver. The two companies are also expanding ongoing target validation work.

Under the original agreement, BMS is using small interfering RNA (siRNA) molecules formulated by Tekmira in LNPs to silence target genes of interest. BMS is conducting the preclinical work to validate the function of certain genes and is sharing the data with Tekmira. BMS will have a first right to negotiate a licensing agreement on certain RNAi products developed by Tekmira that result from gene targets validated by BMS. Tekmira received $3.0 million under the agreement signed last year.

“We have been successfully collaborating with Bristol-Myers Squibb for several years. We are now expanding that work to include further evaluation of Tekmira’s proprietary LNP technology to identify formulations capable of targeting tumors and certain tissues outside of the liver. The new work also includes additional cellular targets that were beyond the scope of the original agreement. Bristol-Myers Squibb will continue to share the data from this research with Tekmira,” said Dr. Mark J. Murray, Tekmira’s president and chief executive officer.

Pfizer Files Crizotinib Applications in U.S., Japan

Posted on May 17, 2011 @ 09:06 am

Pfizer’s NDA for crizotinib, an oral first-in-class anaplastic lymphoma kinase (ALK) inhibitor for the treatment of ALK-positive advanced non-small cell lung cancer (NSCLC), has been accepted for filing and granted Priority Review status by the FDA. An application has also been filed with the Japanese Ministry of Health, Labour and Welfare (MHLW).

“Our ability to file applications for regulatory review in the U.S. and Japan simultaneously only three years after beginning worldwide clinical trials in patients with ALK-positive lung cancer is a testament to the hard work of the crizotinib team and the productive discussions that we have had with the respective regulatory agencies. Given the clinical trial results seen to date, we believe that crizotinib, if approved, may change the treatment paradigm for patients with ALK-positive advanced NSCLC,” said Garry Nicholson, president and general manager, Pfizer Oncology Business Unit.

Crizotinib is an investigational compound that inhibits the anaplastic lymphoma kinase, or ALK. By inhibiting ALK, crizotinib blocks signaling in a number of cell pathways that are believed to be critical for the growth and survival of tumor cells. The compound received orphan drug designation from the FDA in September 2010 and Fast Track status in December 2010.
Dalton, Zafgen Enter Manufacturing Pact

Posted on May 17, 2011 @ 09:06 am

Dalton Pharma Services has entered into a manufacturing services agreement with Zafgen, Inc. to provide cGMP aseptic fill/finish services and analytical support for Zafgen’s lead obesity treatment.

“Adding Zafgen to our growing list of strategic relationships with innovative pharmaceutical clients is an important milestone for Dalton,” said Peter Pekos, Dalton Pharma’s president and chief executive officer. “We are thrilled to be working with the Zafgen team and look forward to a successful collaboration as we advance this breakthrough obesity therapy through clinical development.”

Thomas Hughes, chief executive officer of Zafgen, said, “The alliance with Dalton is a key part of our success in quickly advancing our first-in-class therapy for severe obesity into the next phase of clinical development. As a virtual company, Zafgen benefits tremendously from having the facilities and technical expertise found at Dalton. The opportunity to partner with a company that provides all aspects of manufacturing including the drug product and analytical services fits perfectly with Zafgen’s capital-efficient business model.”
Executive Moves: BASi

Posted on May 17, 2011 @ 09:04 am

Michael Zhou, Ph.D. has been appointed senior director of research and development at Bioanalytical Systems Inc. (BASi). Dr. Zhou will guide the method development program and will lead the company’s discovery bioanalytical support group.

Dr. Zhou joins the company from Synta Pharmaceuticals Corp., where he served as director of bioanalytical chemistry/DMPK. He has expertise in analytical/bioanalytical operations and regulatory compliance, including GLP, cGMP, GCP regulations and ICH, GCLP, BMV guidelines. He has authored more than 50 research articles.

“Michael’s experience will consolidate our already strong reputation for developing the more challenging bioanalytical methods. In his R&D role, Michael will evaluate and implement new cost effective approaches to our bioanalytical process that will accelerate our growth and profitability,” said president and chief executive officer Anthony S. Chilton, Ph.D. “We will increase our international exposure as Michael represents us in industry conferences, meetings and workshops.”
Executive Moves: Novella Clinical

Posted on May 17, 2011 @ 08:58 am

Nick Dyer has been named executive vice president of global business development at Novella Clinical, Inc. Mr. Dyer will be responsible for business development, growth and diversification strategies for the company and will be based in Novella’s Wilmington, NC office.

Mr. Dyer joins the company from Quintiles, where he served as vice president of drug development partnerships, and oversaw a joint venture with a top 10 pharmaceutical company. Previously he led the global contracts and proposals group at PPD.

“Nick’s leadership skills and deep business development experience will help Novella as we expand our business and develop new ways to partner with clients within the biopharma, oncology and medical device arena,” said Novella president and chief executive officer, Richard Staub.
Executive Moves: Aphena Pharma Solutions

Posted on May 16, 2011 @ 09:05 am

Mary G. Foster, PharmD has been appointed corporate vice president of Quality and Regulatory Affairs at Aphena Pharma Solutions, effective June 1st. In this role, Ms. Foster will help Aphena to shape and plan long-term goals for the company, and further enhance adherence to the highest quality and regulatory standards.

Ms. Foster has more than 25 years of experience, and joins the company from Catalent Pharma Solutions, where she served as vice president of quality. In that role, she was responsible for creating a global cGMP program and for training and developing connections within the industry and worldwide regulatory bodies to ensure continuous understanding and improvement of quality processes.

“We’re so pleased to have Mary join the company. It is our intent to employ the industry’s best and brightest, Mary certainly fits that category,” said Aphena president and chief executive officer, Renard Jackson. “She shares our company’s values, our focus on client expectations, and our vision for the future as a single-source industry leader.”

Teva To Acquire Taiyo

Posted on May 16, 2011 @ 09:03 am

Teva Pharmaceutical Industries Ltd. has signed a definitive agreement to acquire 57% of the shares in Taiyo Pharmaceutical Industry Co. Ltd. for $460 million in cash. Teva will also extend an offer to purchase all remaining shares of Taiyo. The total transaction is valued at $1.3 billion.

Taiyo is the third largest generic pharmaceutical company in Japan with sales of $530 million in 2010. The company has a generic product portfolio with more than 550 generic drugs in a variety of therapeutic areas and dosage forms. Taiyo has production capabilities in a range of technologies, including sterile manufacturing in two facilities, as well as a strong R&D team and local regulatory expertise.

Shlomo Yanai, Teva’s president and chief executive officer, said, “This acquisition will enable Teva to deliver on our strategic objective of becoming a leading player in the fast-growing Japanese generics market. In fact, we now expect to reach our 2015 target of $1 billion in sales in Japan ahead of schedule. Taiyo’s strong market reach, cutting-edge production facilities, and impressively large product portfolio, combined with Teva’s scale and capabilities as the world’s largest generics company, will enable us to offer a much wider range of high quality, affordable generics to a much larger segment of the Japanese market.”

Teva expects to complete the transaction by the end of the third quarter. The acquisition is subject to customary closing conditions.
Quintiles, PGT in Genomic Testing Pact

Posted on May 16, 2011 @ 09:01 am

Quintiles and Population Genetics Technologies Ltd. (PGT) have entered a commercial collaboration to bring genomic testing into mainstream drug development in an effort to produce safer, more effective medicines.

The two companies will jointly identify opportunities to apply large-scale genomic analyses — using samples from hundreds to thousands of individuals — to test clinical hypotheses and correlate biomarkers of disease prognosis and drug responsiveness. This approach is aimed at the rapid identification of rare and common genes that collectively account for significant variation in treatment responses. The collaboration will use PGT’s technology, which can process hundreds of genomes simultaneously, in a single sequencing assay, while still retaining the ability to identify each individual genome during post-sequencing data analysis.

“PGT’s technology combined with Quintiles’ global presence can bring the benefits of large-scale sequencing and analysis to virtually all biopharmaceutical companies,” said M. King Jolly, Pharm.D., senior vice president of Quintiles Innovation. “The combination of Quintiles and PGT’s capabilities can, we believe, increase the probability of success in clinical trials, reduce trial enrollment required to achieve statistical significance, and diminish the costs and/or time required to bring a product to market — all while improving product differentiation.”

PGT chief commercial officer Frank Massam, Ph.D., said, “Our first project with Quintiles is a renal cancer clinical trial to identify genetic markers predictive of both adverse events and efficacy, but our workflows are appropriate to all therapeutic areas. We are currently running programs in breast cancer, leukemia and Alzheimer’s disease. We are proud to be associated with the work that Quintiles is leading to deliver real patient benefits from cutting-edge genomic research.”

Executive Moves: ICON

Posted on May 16, 2011 @ 08:59 am

Elizabeth Thomas has been appointed vice president and general manager of ICON’s Bioanalytical Operations in Manchester, UK. Ms. Thomas has more than 30 years of experience in bioanalysis. She joins the company from AstraZeneca, where she was global discipline leader, Bioanalysis. In this role she led the global Bioanalysis group and the company’s bioanalytical and biomarker lab in Manchester, UK. Prior to AstraZeneca, Ms. Thomas managed the bioanalytical groups at both Quintiles and Covance.

Brian O’Dwyer, vice president Bioanalytical Development, ICON Development Solutions, said, “We are pleased to welcome Liz and the significant commercial, operational and strategic experience she brings to our bioanalytical sciences business. While Liz’s principal focus and responsibility will be the general management of our UK laboratory operations, she will also play a major role in harmonizing and expanding our bioanalytical capabilities globally.”

Additionally, ICON has appointed of Dr. Tony Upton associate director of Immunoassay Services, EU. Dr. Upton joins the company from Emergent Ltd., where he managed the company’s internal live and protein based vaccine lab and oversaw external contract laboratories supporting Emergent’s development programs.
AZ, Intomics in Discovery Pact

Posted on May 16, 2011 @ 08:50 am

AstraZeneca and Intomics have signed an agreement to accelerate AZ's drug discovery programs. Intomics will assist in drug discovery projects by providing data, methods, and tools for integrating and analyzing highly complex proprietary clinical, biological and chemical data. The collaboration spans a range of research projects. The financial terms of the agreement were not disclosed.

“We are delighted to assist AstraZeneca with their very exciting research projects. We see a great synergy in combining our data analysis expertise with AstraZeneca’s profound knowledge in some very important disease areas. The collaboration will help facilitate efficient drug discovery projects with shorter turnaround time and improved results,” said Thomas S. Jensen, chief executive officer of Intomics.
Phlexglobal Expands in U.S.

Posted on May 13, 2011 @ 09:00 am

Phlexglobal has expanded in the U.S. with the opening of an office in Philadelphia, PA. The new office will provide Phlexglobal’s trial master file (TMF) services including the PhlexEview eTMF solution, and will initially employ 20 staff, with plans to grow to 50 within the first year. The office will also house a new records center to store live TMF documents for Phlexglobal clients across the U.S.

The opening of the Philadelphia office follows the company’s management buy out (MBO) of the UK private equity firm Inflexion, which will allow Phlexglobal to further expand its provision of clinical trial support for the recent launch of version 3 of its PhlexEview eTMF solution.

Stella Donoghue, Phlexglobal’s managing director, said, “This is an exciting time for Phlexglobal — the launch of a second U.S. office coupled with the recent MBO will provide a valuable platform for the company to move into new markets including Asia-Pacific, while still maintaining a strong presence in the UK and North America.”

Phlexglobal provides clinical research support solutions through its five core services of resourcing, task force, clinical support services, eTMF & document solutions and training.
Paladin, Elan In New Pain Product
 Pact

Posted on May 13, 2011 @ 09:00 am

Paladin Labs has entered into a licensing and distribution agreement with Elan Corp. under which Paladin has exclusive Canadian rights to market and sell (upon regulatory approval) Elan’s controlled release hydrocodone product for the treatment of moderate to severe pain. Elan will receive an undisclosed upfront payment for the product, milestones and manufacturing fees and royalties based on sales.

Currently, there is no single-entity, controlled-release formulation of hydrocodone in Canada. The product, which incorporates Elan’s proprietary SODAS technology, offers a controlled-release profile, which uses both immediate release and extended release properties designed to enable twice daily dosing. The product is currently in two Phase III trials in the U.S. and is expected to be submitted for Health Canada approval in 1H12.

“We are excited to add a further treatment option for Canadian pain sufferers and their physicians,” said Jonathan Ross Goodman, president and chief executive officer of Paladin Labs, Inc. “This product, if approved, will complement our dynamic and growing promoted pain portfolio, which already includes Tridural, Metadol, and Abstral and will provide us an additional pillar upon which to strengthen our pain franchise.”
Executive Moves: Ockham

Posted on May 13, 2011 @ 08:59 am

Harman Dubé has been appointed vice president of the Preclinical and Regulatory Affairs group within OckhamCRO. Dr. Dubé has 14 years of experience in developing and directing a variety of drug and device development programs, supporting pharma and biopharma organizations with development efforts. Her areas of experience include consultation on, and management of, non-clinical studies, CMC activities and U.S. and International regulatory filings, technical writing and project management.

Prior to joining the company, Dr. Dubé headed the drug development program at Thrasos Innovation in Canada, managing all aspects of planning and execution of non-clinical studies, regulatory filings and Phase I study operations. Dr. Dubé also led the drug development efforts for PainCeptor Pharma (Canada), managing the clinical, regulatory, and CMC activities for two pain programs. Prior to that, she spent 10 years at Abbott Laboratories in the U.S., where she held positions of increasing management responsibility in the areas of project management, pre-clinical, applied research, and strategic marketing programs.

Ockham’s chief executive officer, James Baker, said, “We are pleased to have such an experienced leader enhance Ockham’s service offerings in Product Development and Regulatory. We see a tremendous need for this service as we try and work with our sponsors to get needed products to market faster, in order to enhance our quality of life.”
Financial Report: Dr. Reddy’s 4Q10

Posted on May 13, 2011 @ 08:57 am

Dr. Reddy’s 4Q10

4Q Revenues: $453.0 million (+23%)

4Q Earnings: $75.0 million (+101%)

FY Revenues:
$1.7 billion (+6%)

FY Earnings: $248.0 million (earnings were $24.0 million FY10)

Comments: North America revenue growth was 18% for the year, with 11 new product launches. Russia had revenue growth of 29% with volume growth and OTC initiatives. India had revenue growth of 15%, with continued growth of key brands and new products. Germany revenue was down 17% in Euro terms, but had improved profitability. Global Generics revenue was $1.2 billion for the year (+10%), led by performance in North America and Emerging Markets.
Cambridge Major Sites Inspected, Launches API

Posted on May 12, 2011 @ 08:41 am

The Germantown, WI facility of Cambridge Major Laboratories (CML) has undergone its first FDA inspection and commercial launch of an API. The company’s manufacturing facilities were the subject of a FDA inspection, which included a pre-approval inspection (PAI) and a general quality systems inspection of both sites.

The FDA inspection represents the first for CML's newest, large-scale API manufacturing facility and the company's seventh inspection in the past nine years. CML currently manufactures more than a dozen commercial products including innovative new drugs, generic substances, and medical imaging agents.

“The inspection and subsequent commercial launch is a major milestone for CML, which is the first for our new, state-of-the-art, large-scale API facility,” said Brian Scanlan, CML's president and chief executive officer. “Our objective, as always, is to ensure that our systems are in compliance with FDA requirements. I am very pleased with the outcome of the inspection which demonstrates the full devotion of the management and employees.”

Within two months of the successful PAI, the FDA announced approval of the product, which represents the first commercial product produced in CML's new facility. “The NDA approval is a significant milestone for our newest facility and a clear sign that we are open for business at the facility,” said Mr. Scanlan.
Executive Moves: Catalent Pharma Solutions

Posted on May 12, 2011 @ 08:33 am

Harry Jeffreys has been appointed vice president of Quality Management Systems and Compliance at Catalent Pharma Solutions. He will be responsible for leading the Quality Management System (QMS) and Compliance team and driving excellence in these areas across the company. Mr. Jeffreys will be partnering across Catalent and with customers to ensure a quality experience through the implementation of a robust, agile and sustained QMS that meets all customer and regulatory agency requirements and expectations. He will be based at Catalent’s corporate headquarters in Somerset, NJ.

Mr. Jeffreys joins the company from the Medical Diagnostics Division at GE Healthcare, where he held various leadership roles in Quality. Most recently, he was the Quality Assurance Executive and a member of the executive leadership team, where he was responsible for quality compliance of the supply chain, R&D, clinical and post-market/patient safety organizations.

“I am delighted to bring Harry’s experience to Catalent and am looking forward to his leadership and direction as we accelerate new levels of quality excellence across our business,” said Sharon Johnson, senior vice president of Catalent’s Global Quality.
Oncolytics Biotech, SAFC In Supply Pact

Posted on May 12, 2011 @ 08:32 am

Oncolytics Biotech has entered into a commercial supply agreement with SAFC, a division of Sigma-Aldrich Corp., for the commercial manufacture of Oncolytics’ reovirus, Reolysin. SAFC will perform process validation, continue to supply clinical requirements, and will supply commercial material upon approval.

“As a leading global provider of high-quality and reliable biologics manufacturing services we are eager to work with companies focused on bringing novel products to market,” said Gilles Cottier, president of SAFC. “SAFC has worked closely with Oncolytics to develop, scale-up, and optimize manufacturing of REOLYSIN, advancing it to the commercial level.”

“This agreement represents a significant step forward in the drive to commercialize Reolysin as we prepare to produce expanded clinical supplies and build inventory for potential commercial sales,” said Dr. Matt Coffey, chief operating officer of Oncolytics. “Having worked with a recognized world leader on the efficient manufacture of Reolysin for several years now, we feel we are well positioned with this element of our overall plan to commercialize Reolysin.”
Executive Moves: Irvine Pharmaceutical Services

Posted on May 12, 2011 @ 08:31 am

Dr. Dorla Mirejovsky has been appointed senior director of Formulation Development at Irvine Pharmaceutical Services. Dr. Mirejovsky has more than 25 years of experience in pharmaceutical development, drug delivery, and manufacturing of injectable drugs.

Dr. Mirejovsky most recently was responsible for the development and manufacture of several drug candidates at Spectrum Pharmaceuticals, where she authored CMC submissions for one NDA and several INDs. Previously, she spent nine years at Sicor Pharmaceuticals developing numerous injectable products including Propofol Injectable Emulsion. Dr. Mirejovsky has had similar roles at ISIS Pharmaceuticals and Allergan.
Astellas, BioFocus Sign Target Discovery Pact

Posted on May 12, 2011 @ 08:10 am

BioFocus has signed a collaboration agreement with Astellas Pharma focused on discovering novel targets in the field of CNS disorders. BioFocus will utilize its SilenceSelect target discovery platform to deliver validated targets to enhance the Astellas neurology pipeline and will receive research funding and success payments based on the progress of the collaboration. Financial terms were not disclosed.

“We are delighted to support Astellas Pharma in its research,” said Dr. Chris Newton, senior vice president Galapagos Services and managing director BioFocus. “Our target discovery offering allows clients to access a unique platform providing rapid identification of novel targets through a proven technology.”
Financial Reports: Bioanalytical Systems, Inc. 2Q11

Posted on May 12, 2011 @ 08:03 am

BASi

2Q Revenues: $8.4 million (+21%)

2Q Earnings: $483,000 (loss of $1.2 million in 2Q10)

YTD Revenues: $16.5 million (+24%)

YTD Earnings: $793,000 (loss of $2.7 million YTD10)

Comments: For the quarter, Service revenue rose 23% to $6.4 million while Products revenues were up 17% to $2.0 million. For YTD, Service is up 25% to $12.6 million and Products are up 21% to $3.9 million. BASi president and chief executive officer Anthony Chilton remarked, "The increase in revenue reflects the success of our efforts to build business with existing clients and expand our client base, as we leverage BASi's well-established reputation for providing innovative, high quality services and products that increase efficiency and reduce the cost of taking a new drug to market. Start-ups, biotechs, generics and other new sectors of the drug development industry are especially attractive targets for our services."
Executive Moves: Patheon

Posted on May 11, 2011 @ 09:13 am

Michael E. Lytton has been appointed Patheon’s executive vice president of Corporate Development and Strategy and general counsel. Mr. Lytton most recently served as executive vice president, Corporate and Business Development at Biogen Idec, where he reported to Jim Mullen, previously chief executive officer of Biogen Idec and now Patheon’s chief executive officer.

Mr. Lytton has 28 years of experience in the pharmaceutical and biotech industry. Most recently, he led Biogen’s corporate development team that executed its corporate partnership strategy, including the in-licensing of several late-stage molecules. Prior to joining Biogen, Mr. Lytton was a general partner with Oxford Bioscience Partners, a venture capital firm investing in therapeutic, diagnostic, and life science tool companies. Prior to Oxford, Mr. Lytton practiced law for 17 years and specialized in representing biomedical companies. Mr. Lytton is currently chairman of the board of Santhera Pharmaceuticals AG.

Mr. Mullen said, “I am so pleased that Michael has agreed to join us. He is an accomplished leader, strategist and negotiator who will bring a deep and broad understanding of the industry and proven skills to help Patheon reach its full potential. I expect that Michael will assist us in building strategic alliances with our pharmaceutical and biotechnology customers as well as emerging companies and their investors, and that he will enable us to add a range of proprietary capabilities and technologies to better serve our customers.”
Halozyme, ViroPharma to Develop Subcutaneous Cinryze

Posted on May 11, 2011 @ 09:12 am

Halozyme Therapeutics and ViroPharma have signed a worldwide exclusive licensing agreement for the use of rHuPH20 (recombinant human hyaluronidase) for the development of a subcutaneous formulation of Cinryze (C1 esterase inhibitor [human]). Halozyme may receive as much as $83 million, with $9 million upfront and potential future milestone payments of $74 million based on clinical and regulatory targets, plus a 10% royalty on future sales. ViroPharma will have exclusivity to C1 esterase inhibition and to the hereditary angioedema (HAE) indication, along with three additional orphan indications. ViroPharma will fund all development and commercialization expenses for the program.

Cinryze received FDA approval for intravenous administration for routine prophylaxis against angioedema attacks in adolescent and adult patients with hereditary angioedema. A combination formulation of Cinryze with rHuPH20 for subcutaneous administration is expected to enter clinical trials by the end of the year.

“Halozyme’s rHuPH20 enzyme may facilitate the subcutaneous administration and absorption of a broad range of pharmaceuticals and biologics, including plasma-derived proteins such as Cinryze,” stated Gregory I. Frost, Ph.D., Halozyme’s president and chief executive officer. “The commercial success of Cinryze is notable, and we look forward to working with ViroPharma to simplify the self-administration of this important biologic that may ultimately provide a more convenient product for as many people as possible with HAE worldwide.”
ICON, Boston Research Institute in Strategic Alliance

Posted on May 11, 2011 @ 09:10 am

ICON has entered a strategic alliance with Boston Clinical Research Institute (BCRI), an Academic Research Organization. The alliance will combine BCRI’s leadership in clinical strategy, study planning and academic relationships with ICON’s experience in the execution of global clinical trials.

BCRI provides scientific consultancy in study design using expert clinicians and key opinion leaders from premier medical institutions, and also maintains a network of global investigators in all of the medical specialties and subspecialties.

“We are extremely pleased to announce the partnership with ICON,” said Dr. Michael Gibson, founder and senior consultant at BCRI. “We believe that the future of clinical research is collaboration between the ARO and the CRO. ICON clearly recognizes the incremental benefits of collaboration with the thought leaders in the medical community to optimize study planning, execution, and credibility.”

Peter Gray, chief executive officer at ICON, said, “We are delighted that Dr. Gibson and BCRI have aligned with ICON. The relationship provides ICON and its clients with access to a breadth of expertise in the key opinion leader community and to investigators worldwide, including national and international leaders. Anticipated benefits include enhanced planning, design, site selection and enrolment performance.”

EMD Millipore Opens New Shanghai Facility

Posted on May 11, 2011 @ 09:09 am

EMD Millipore, the Life Science division of Merck KGaA, has opened its Biopharmaceutical Technical and Training Center in Shanghai, China. The 28,000-sq.-ft. facility will provide support, training and validation services to EMD Millipore’s biopharma customers with operations in China.

“We are responding to China’s commitment to strengthen regulatory requirements designed to ensure drug safety,” said Jean-Paul Mangeolle, head of EMD Millipore’s Process Solutions business. “Our new Biopharmaceutical Technical Center is unique in that we can support and even train our pharmaceutical customers to meet the new Chinese and global regulations. Today we have taken a significant step not only expanding our 30 years of local offerings in China, but also to support the effort to produce safe, quality drugs in this important and fast growing region.”
Immunologix, DavosPharma In Antibody Pact

Posted on May 11, 2011 @ 09:08 am

Immunologix and DavosPharma have formed a strategic alliance under which DavosPharma will represent and market human antibodies produced by Immunologix. Immunologix specializes in transforming naïve B-cells to produce 100% human monoclonal antibodies that can target all antigens including, cancer, viruses, bacteria, toxins and autoimmune diseases like diabetes, lupus, rheumatoid arthritis and multiple sclerosis. DavosPharma evaluates, coordinates and delivers chemistry through strategic partners to provide breakthrough solutions for drug development.

“The relationship between Immunologix and DavosPharma has been building since initial discussions began in December of 2010. We are extremely excited to partner with DavosPharma since they bring an experienced team of experts to Immunologix. The partnership allows both parties to offer their clients a platform to 100% human monoclonal antibody ready for clinical trials. It will help in bringing our game-changing technology to the pharmaceutical marketplace,” said Dr. Ryan Fiorini, founder and chief operating officer, Immunologix.

Barry Robins, president of DavosPharma, said, “The Immunologix platform of technology offers a new paradigm for therapeutic antibody discovery, development, and manufacturing. Our customers will understand that the ability to identify and produce a 100% human monoclonal antibody in less than six months with less adverse side effects is an extremely significant differentiator. The technology that we now offer through this strategic alliance will have an immediate impact on shorter development times, costs, and reduction of adverse effects due to immunogenicity.”

Hovione Undergoes Six Successful GMP Inspections

Posted on May 11, 2011 @ 09:07 am

Hovione has recently undergone six successful GMP inspections by major government agencies in the past eight months. The Japanese PMDA inspected sites in China and Portugal. The FDA inspected sites in Loures twice and New Jersey once. Also, the Portuguese authorities performed an inspection in April. The FDA inspected both NJ and Loures sites simultaneously, and no Form 483 was issued. The PMDA inspections were also successful.

The inspections are the result of client submissions for innovator drugs, generics, and devices using Hovione APIs or technologies that focus on particle properties in high-performing formulations.

“Our clients are thrilled. Successful outcomes at inspections is not an unusual event at Hovione, but to continue with this kind of stellar record in the current climate is something that makes us all really proud,” said Guy Villax, Hovione’s chief executive officer.
SynCo To Make Acromegaly Drug for Syntaxin

Posted on May 11, 2011 @ 08:44 am

SynCo Bio Partners B.V. has signed an agreement to produce Syntaxin's novel drug candidate SXN101959. Syntaxin is developing SXN101959 for the therapeutic treatment of acromegaly as a primary indication. SynCo will assist Syntaxin in scale-up and manufacture of multiple batches of bulk drug substance and drug product of SXN101959 for non-clinical, Phase I and Phase II clinical trials.

In acromegaly, hypersecretion of growth hormone usually occurs from a benign pituitary tumour. Current first line therapy is the use of somatostatins, to reduce secretion; however, up to 60% of patients are refractory to this treatment so there is a significant unmet need for new products. Syntaxin's Targeted Secretion Inhibitors (TSI) mechanism of action provides a unique and potentially superior approach to the inhibition of growth hormone release.

Pierre Warffemius, chief executive officer of SynCo Bio Partners, remarked, "SynCo is pleased to be working with Syntaxin on the manufacture of SXN101959 for the treatment of acromegaly. We aim to establish a long-term relationship with Syntaxin to support its unique TSI platform and expanding product portfolio, by providing high quality manufacturing and filling services."

Dr, Melanie Lee, chief executive officer of Syntaxin, commented, "SynCo's manufacturing capability provides us with the means to rapidly move SXN101959 through to Phase I clinical trials in acromegaly."

Recently, Syntaxin's partnered molecule AGN-214868 entered Phase II clinical trials in post-herpetic neuralgia (PHN).
Financial Reports: WuXi PharmaTech 1Q11

Posted on May 11, 2011 @ 08:39 am

WuXi PharmaTech

1Q Revenues: $93.6 million (+16%)

1Q Earnings: $18.2 million (+17%)

Comments: Laboratory Services revenues grew 12% and Manufacturing Services were up 35% for the quarter. Manufacturing growth was driven by ramp-up of large-scale commercial manufacturing and increased demand for clinical trial materials. Gross margins in manufacturing rose from 19.9% to 26.7%, while Laboratory Services' gross margins dropped from 41.4% to 39.6% due to higher labor costs, Chinese currency appreciation against the dollar, and depreciation expenses from expansion investments. Exchange rates accounted for $1.2 million of the quarter's earnings.
PPD Expands Consulting Services

Posted on May 10, 2011 @ 11:03 am

PPD, Inc. has established four practice areas through PPD Consulting: biosimilars, adaptive trial design, China regulatory strategy and cardiovascular outcomes studies. These services were established to help clients meet unique product development challenges.

PPD Consulting offers clinical, regulatory and commercial program strategies to a range of development programs for small molecules, vaccines, biologics, biosimilars, diagnostics and devices. The team also works with biopharma and medical device companies to help address gaps in strategic resourcing and to gain strategic insight for long-term development and planning activities. PPD’s consulting services with biosimilar development aims to help clients to select appropriate endpoints, design more efficient clinical trials and develop effective regulatory strategies.

“PPD has a strong team of physicians, regulatory experts, scientists and biostatisticians with extensive experience in creating and implementing product development plans from preclinical through post-approval on global and local levels,” said Christine Dingivan, M.D., chief medical officer of PPD. “We have aligned our consulting practice to the areas where we continue to see a strong need for our services to help our clients address significant regulatory and market challenges.”
MedImmune Granted Access to Pfenex Technology

Posted on May 10, 2011 @ 11:02 am

Pfenex, Inc. has entered a three-year strategic collaboration with MedImmune, the global biologics business of AstraZeneca, granting MedImmune non-exclusive access to Pfenex Expression Technology and resources for the development of bioprocesses for therapeutic proteins and vaccines.

Pfenex, Inc. will engineer production strains and develop early production processes for MedImmune’s molecules. MedImmune will have access to the expression platform and process development team in an effort to enable faster preclinical and clinical development for these molecules. MedImmune will provide annual technology access fees, FTE resource funding and pre-agreed commercial license terms.

“This partnership with MedImmune will facilitate speed and reliability in the development of protein therapeutics and vaccines to serve unmet medical needs,” said Dr. Bertrand Liang, chief executive officer of Pfenex, Inc. “Integrating our efforts early will allow for the rapid progression of early stage candidate molecules through discovery and development.”

“We are very excited to initiate this collaboration with Pfenex,” said Dr. Gail Wasserman, senior vice president of Biopharmaceutical Development at MedImmune. “Their scientific approach to strain development and protein expression is robust and aligned with the way we work at MedImmune. Working collaboratively with Pfenex by harnessing their novel platform will play an important role in helping accelerate some of our early pipeline programs.”
Randox Pharma Adds Biomarker Discovery Service

Posted on May 10, 2011 @ 11:01 am

Randox, a supplier of biomarker discovery services for the development of new biomarker assays, companion diagnostics, and the manufacture of clinical diagnostic reagents, has recently developed QuantiPlasma Array, a monoclonal antibody microarray designed to assess the level of multiple proteins simultaneously in human plasma.

According to the company, each kit contains 300 unique monoclonal antibodies, making it possible to directly assess the plasma proteome dynamics of normal and disease state plasma samples for identification of novel biomarkers in conjunction with Randox’s Biochip Array Technology analyzer platform.
Onyx Scientific Wins Phase I API Contract

Posted on May 10, 2011 @ 11:00 am

Onyx Scientific has been award a contract from Cancer Research UK to develop the chemistry and perform the GMP synthesis of an API for use in a Phase I trial. The technical team at Onyx Scientific was able to improve the synthetic methodology as well as provide an alternative route for the API, which will potentially help make the project more efficient and cost effective in the long term.

Dr. Nigel Westwood, drug supply manager at Cancer Research UK, said, “Having had a very positive experience of using Onyx Scientific’s process development and GMP manufacturing services in the past, they seemed like a strong candidate for this important project.

Denise Bowser, commercial director at Onyx Scientific, said, “We are delighted to be working again with the team at Cancer Research UK on this major project as it clearly indicates confidence in our technical expertise, customer service and ability to deliver on time. The input we have had to date has been positive and has no doubt demonstrated our commitment to go the extra mile for clients by meeting their requirements as efficiently as possible.”

Quay Expands in New Facility, Passes MHRA

Posted on May 10, 2011 @ 09:51 am

Quay Pharma has begun investing and expanding in its recently opened Deeside, North Wales facility. The new site has also undergone a successful re-inspection by the MHRA, confirming Quay's GMP compliance.

The site's new equipment includes a state-of-the-art ion chromatography system, which the company added to support two new projects requiring specialist analytical capability. The first of the projects concerned is for a French biopharma that is developing products for severe neurological disorders. The system will be used with pulsed amperometry electrochemical detection to monitor extremely low levels of sugars in a combination drug product. The second project, for a new UK pharma, involves measurement of a cationic drug and its degradation products by conductivity detection.

Quay's formulation development department, which specializes in the development of solid dosages, creams, liquids and gels, has been expanded to include a new pilot facility alongside the laboratory. The pilot lab will offer the capability for early phase work in standard techniques such as tableting, coating and capsule filling, as well as more complex processes such as extrusion spheronization and semi-solid and liquid filling and banding of capsules. It will assist in scale up, as well as providing proof of concept studies and samples for pharmacokinetic (PK) studies.

In addition to these investments, Quay is also planning to introduce new GMP manufacturing suites, with work on these expected to commence 3Q11. Quay Pharma’s chief executive officer, Mike Rubinstein, remarked, “The move to the new premises has effectively quadrupled the available space for these important departments and will allow us to provide a greatly enhanced range of services to both existing and new customers.”
Executive Moves: Pfizer CentreSource

Posted on May 10, 2011 @ 08:28 am

Cristin B. Grove has been named director, Global Contract Manufacturing for Pfizer CentreSource (PCS), an operating unit within Pfizer Global Supply (PGS). With Pfizer since 1993, Ms. Grove most recently served as business development manager for PGS, responsible for increasing revenue by identifying, assessing and selecting opportunities for product enhancement and expansion through leveraging (Pfizer Kalamazoo) plant strengths across high barrier niches.

“Cristin brings an unbeatable combination of industry expertise, a keenly advanced skill set, and enthusiasm to her new role. She will be a competitive advantage to Pfizer CentreSource and to Pfizer moving forward,” said PCS president Michael Kosko.

Ms. Grove previously held the roles of senior manager/team leader, Non-sterile Liquids Operations (Pfizer Kalamazoo, MI), manager/team leader Manufacturing (Pfizer Holland, MI), and assistant production manager (Pfizer Little Island, Cork, Ireland). Prior to joining Pfizer, she worked for CentreSource predecessor-company Parke-Davis as an environmental engineer.
Alkermes to Merge With Elan Drug Technologies

Posted on May 9, 2011 @ 09:09 am

Alkermes, Inc. has entered a definitive agreement to merge with Elan Drug Technologies (EDT), the drug formulation and manufacturing business unit of Elan, for approximately $960 million in cash. The combined companies will be named Alkermes plc.

Alkermes plc will have revenue from 25 commercialized products, with future growth expected from products Risperdal Consta, Invega Sustenna, Ampyra, Vivitrol and Bydureon. The combined company is expected to have product, royalty and manufacturing revenues of more than $450 million annually and resources to invest in its pipeline.

“The merger will be financially transformative and create a profitable, global biopharmaceutical company with a diversified CNS product portfolio and a strong foundation for growth,” said Richard Pops, chief executive officer of Alkermes. “Both companies have a proven track record as innovators. This merger will bring the scale and resources for strategic and balanced investment across the whole product continuum, from R&D innovation to clinical development, to world-class manufacturing and commercial expansion. We’re looking forward to working with the EDT team to accelerate growth and to create value for our shareholders and the patients we serve.”

Kelly Martin, chief executive officer of Elan plc said, “Upon closing, this transaction aggressively advances a number of long-standing strategic and financial objectives for Elan. Namely, it enables us to reduce the debt on our balance sheet and further improve our capital structure, increases operating leverage, allows for additional focus and continued disciplined investment in a broad array of opportunities within the neurology space from a scientific, clinical and product point of view and lastly, provides Elan shareholders with the opportunity to realize further value – over time – from the equity position in Alkermes plc.”

Cook To Open New Plant

Posted on May 9, 2011 @ 09:07 am

Cook Polymer Technology, a raw materials manufacturer and part of Cook Group, will expand its operations by opening a new plant in Canton, IL. The new plant, called Cook Polymer Technology – Canton, will be a specialized manufacturing facility producing polytetrafluoroethylene (PTFE) tubing, which is widely used by Cook Medical’s business units. When fully operational, the plant will employ approximately 30 people. The company anticipates full production functionality in about two years.

“Cook is excited about building this new plant in the city of Canton,” said David Lessard, vice president and general manager of Cook Polymer Technology. “We will continue Cook’s commitment of creating jobs and economic development in the area, and are grateful to the state of Illinois, Mayor Meade, and the economic development team in Canton for their support and cooperation in these projects.”
Evotec Achieves Twelfth Boehringer Milestone

Posted on May 9, 2011 @ 09:06 am

Evotec AG has achieved a twelfth milestone in its research alliance with Boehringer Ingelheim, triggering a $2.9 million payment to Evotec. The milestone was for the transition of an oncology program into lead optimization.

Dr. Mario Polywka, chief operating officer of Evotec said, "This is the twelfth milestone achieved as part of this alliance with Boehringer Ingelheim and the third against an oncology target. We are now in our eighth year of this collaboration and this milestone again validates the strength of the joint Evotec / Boehringer research groups as they drive new drug candidates to the clinic."

The multi-target drug discovery alliance aims to jointly identify and develop preclinical development candidates for the treatment of various disease areas including CNS, inflammation, cardiometabolic, respiratory diseases, and cancer. Boehringer Ingelheim has full ownership and global responsibility for clinical development, manufacturing and commercialization of the compounds identified. In return, Evotec receives ongoing research payments and preclinical milestones.
Pfizer’s Prevnar 13 Meets Phase III Endpoints

Posted on May 9, 2011 @ 09:02 am

Pfizer met all study endpoints in two Phase III immunogenicity and safety trials of Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in adults aged 50 years and older. This data was used for the regulatory filings that have been submitted in the U.S., the EU and other countries.

Data from both studies showed that Prevnar 13 was as immunogenic as the currently licensed nonconjugated pneumococcal polysaccharide vaccine (PPSV) for the 12 serotypes common to both vaccines in the age groups studied who were either pneumococcal vaccine-naïve or previously immunized with PPSV. Also, the secondary endpoint data from both studies showed that Prevnar 13 had a statistically significant higher functional antibody response than PPSV against a majority of serotypes common to both vaccines and serotype 6A, a serotype not contained in PPSV.

“Prevnar 13 represents an important scientific achievement and we are excited about the potential to further define its clinical utility with the aim of broadening pneumococcal disease prevention efforts,” says Emilio Emini, Ph.D., chief scientific officer, Vaccine Research, Pfizer Inc. “Adults 50 years and older are a population at heightened risk for pneumococcal disease, which imposes a significant public health and economic burden worldwide.”
Myoderm Expands in European Market

Posted on May 6, 2011 @ 08:00 am

Myoderm has been granted a Wholesale Dealer License from the Medicines and Healthcare products Regulatory Agency (MHRA), expanding its position within the European pharmaceutical market. Myoderm has also established a new partnership with a European pharmaceutical logistics provider.

The MHRA license agreement allows Myoderm to buy, sell and distribute pharmaceuticals within the UK and facilitates more direct access to drug
manufacturers across Europe. Additionally, Myoderm’s new partnership will allow the company to offer receiving, inspection, warehousing and distribution of pharmaceutical products, providing complete control over materials obtained and distributed throughout Europe.

“Acquiring our Wholesale Dealer License and partnering with a leading European, Pharmaceutical logistics provider is critical to our continued effort to enhance our worldwide supply capabilities,” said Mike Cohen, Myoderm’s managing director.
Quotient Clinical Completes Expansion

Posted on May 6, 2011 @ 07:59 am

Quotient Clinical, a business unit of Quotient Bioresearch, has completed a major expansion of its clinical facilities in Nottingham, UK. The expansion includes a 50% increase in bed capacity and a dedicated sample processing lab for human ADME studies. The new facilities have been inspected and approved for use by the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA), and have been awarded Supplementary Accreditation.

The facilities will operate under Quotient’s Synthesis-to-Clinic platform in support of human ADME studies, reinforcing the company’s provision of 14C-enabled drug development services including Phase 0 microdose, ivMicrotracer, and human metabolism studies.

Mark Egerton, M.D. of Quotient Clinical, said,“In parallel with the recent expansion of our Pharmaceutical Sciences laboratory and GMP drug product manufacturing facility, the completion of this clinical expansion is another milestone in the development of our business. It underlines the strength of our Synthesis-to-Clinic platform and the benefits it brings to our global client base. Our expanded facilities will assist the continued development of our services, supporting our customers in taking new and innovative approaches in early drug development.”
Executive Moves: Penn Pharma

Posted on May 6, 2011 @ 07:56 am

Mark Dean-Netscher has been appointed chief operating officer of Penn Pharma, effective May 16th. Mr. Dean-Netscher will be responsible for overseeing operation of the company’s specials and global contract manufacturing and development services, including analytical services, formulation, clinical trial supplies, logistics and commercial manufacturing and packaging.

Mr. Dean-Netscher has more than 20 years of experience in the pharmaceutical manufacturing industry. He has held senior positions including heading up Reckitt Benckiser’s global healthcare operation and most recently, overseeing a significant portion of Catalent’s global production facilities as operations vice president International and Europe.

Penn’s chief executive officer, Richard Yarwood, said, “We are delighted to welcome Mark on board. I am confident that he will be able to work competently as part of our senior management team to further strengthen the business’s market presence and to ensure that Penn Pharma remains a well-known and well-respected name worldwide.”
Axcan Pharma, Eurand Renamed Aptalis Pharma

Posted on May 6, 2011 @ 07:53 am

Axcan Pharma Holding B.V. and Eurand N.V. have renamed of their combined companies to Aptalis Pharma. The two companies are working to develop therapies to treat cystic fibrosis and gastrointestinal disorders. Axcan completed its acquisition of Eurand N.V. in February 2011.

Aptalis Pharmaceutical Technologies, formerly known as Eurand Pharmaceutical Technologies, will continue to develop and manufacture products, as well as support the drug development efforts for Aptalis Pharma’s pipeline of products.

Aptalis has a portfolio of oral drug delivery technology platforms including customized drug release, bioavailability enhancement, and taste masking. Aptalis Pharma can now provide licensing, manufacturing, and R&D capabilities for customized drug formulation solutions across a range of dosage forms and therapies.
Executive Moves: Almac Clinical Technologies

Posted on May 6, 2011 @ 07:48 am

Todd Kole has been named vice president of Clinical Project Services (CPS) and a member of the Executive Leadership Team at Almac Clinical Technologies. Mr. Kole will oversee clinical project management and drug supply services globally and will report to the president of Almac Clinical Technologies.

Mr. Kole has extensive experience in the biopharmaceuticals industry, with specialized expertise in clinical technologies and clinical supplies management. He has served in a variety of roles involving the provision of Interactive Voice and Web Response Systems (IVR/IWR) technologies, clinical and technology personnel management, as well as global project and client account management.

Mr. Kole joins Almac after 12 years at Clinphone and Perceptive Informatics. At Clinphone Mr. Kole served as director of U.S. Operations before being promoted to vice president of Global Client Services. During his tenure as vice president of IVR Operations at Perceptive Informatics, Mr. Kole held P&L responsibilities and was a member of the Perceptive Executive Management Team.

Jim Murphy, president of Almac's Clinical Technologies business unit said, “We are very pleased that Todd Kole has joined Almac. He brings a tremendous amount of industry experience to our firm that will help Almac maintain high levels of operational excellence as we continue to grow. Further, given the depth of his drug supply expertise, Todd will be instrumental to the continuing advancement of Almac’s market leading total drug supply chain management service. We welcome Todd to Almac and know he will have a profound impact on the development of the team and our client relationships.”

INC Research To Acquire Kendle

Posted on May 5, 2011 @ 09:42 am

INC Research has entered a definitive merger agreement to acquire Kendle International for approximately $232 million in cash. Kendle is a top global CRO with Phase I-IV clinical development expertise and more than 3,000 associates in 31 countries. Kendle’s board unanimously approved the transaction, which is expected to close in the third quarter, subject to customary closing conditions. Company founder Candace Kendle announced she was stepping down from her roles as president and chief executive officer in February 2011. She became non-executive chairman of Kendle as of May 1.

“Joining forces with INC Research is the right decision for our customers and shareholders. Combining our highly complementary assets will provide the scale and scope for the combined company to deliver outstanding global teams, therapeutic expertise and operational excellence for clinical trials of all sizes,” said Kendle president and chief executive officer, Stephen Cutler, Ph.D. ”Because both companies are known for conducting high-quality clinical work and share a common culture based on excellent service delivery, we will be able to maintain a customer-centric focus on each individual project.”

“The combination of INC Research and Kendle will enable us to deliver broader capabilities and reach a critical mass for the emerging drug development outsourcing and alliance partnership models,” said James Ogle, chief executive officer of INC Research. ”Together, we bring complementary strengths and expand the breadth and depth of services and expertise that are most valuable to our customers.”
Financial Report: Covance 1Q11

Posted on May 5, 2011 @ 09:40 am

Covance

1Q Revenues: $502.0 million (+4%)

1Q Earnings: $32.7 million (-16%)

Comments: Early Development revenues were $224.0 million (+9%). Toxicology performance continued to improve in the quarter. Late-Stage Development revenues were flat at $278.0 million. Improved clinical development was partially offset by lower central lab revenues. The company’s backlog at March 31, 2011 grew 31% to $6.3 billion. Foreign exchange positively impacted backlog by approximately $127 million. Adjusted net orders (adjusted for dedicated capacity contracts) were $564 million in the quarter. Restructuring costs were $5.9 million in the quarter.

SCM Pharma Gets Aseptic Fill Project

Posted on May 5, 2011 @ 09:29 am

SCM Pharma has secured a sterile filling and packaging project with Molteni Therapeutics, a specialty pharmaceutical company based in Italy, for a new drug substance in development for the topical treatment of infected skin lesions using the PhotoDynamic Therapy (PDT) approach.

SCM will provide product supply of an aseptically manufactured gel for a Phase II trial. This follows a successful initial collaboration for Phase I trials. The production process involves the thermal sterilization of a bulk solution before being mixed with the API and aseptically filled using isolator technology into small volume vials. The product is then labeled, randomized, packed and released to the clinical trial sites from the SCM’s MHRA-licensed facility.

Giacomo Chiti, head of analysis and bioanalysis at Molteni Therapeutics, said, “SCM Pharma demonstrated strong technical knowledge during the development stage of our project and have since shown their expertise in production and packing this investigational medicinal product. Their introduction of in-house sterility testing along with the team’s flexible approach to help meet our needs made them the ideal choice to support our scaled-up Phase II clinical trial supply needs.”

Executive Moves: CMC Biologics

Posted on May 5, 2011 @ 09:27 am

Claes Glassell has been appointed chief executive officer of CMC Biologics. Mr. Glassell joins the company from Cerus Corp., where he served as chief executive officer. Prior to that he was president of Cambrex Corp. Mr. Glassell joined the CMC board of directors in 2005. Previously, he held senior positions with Akzo Nobel NV, Nobel Industries AB and Berol Kemi AB. His areas of expertise include 20 years of executive positions in publicly listed life sciences companies responsible for bioprocessing, active ingredients, registered therapeutic agents and various support services.

“We are thrilled that Claes has joined the CMC executive team,” said David Kauffmann, CMC’s chairman and managing director of European Equity Partners. “Claes has been on CMC’s board of directors for more than five years, and has during that time exhibited a broad range of experience and insight of our industry. Claes’ strong leadership qualities and seasoned business understanding makes him the ideal leader to take CMC Biologics to the next level as a leader in our fast-moving industry.”
Executive Moves: Catalent Pharma Solutions

Posted on May 4, 2011 @ 09:26 am

Rao Tatapudy, R. Ph., Ph.D. has been named vice president of Scientific Affairs, Innovation & Growth at Catalent Pharma Solutions. Dr. Tatapudy will be responsible for strategic programs in R&D and technology platforms with a focus on innovation and growth of current technology platforms and advances in bioavailability enhancement, taste masking, modified release and particle engineering. He will be located at Catalent’s corporate headquarters in Somerset, NJ.

Dr. Tatapudy joins Catalent from Pfizer, where he was New Product Leader and director of New Product and Process Development, with responsibility in Global Manufacturing services. Prior to Pfizer, he spent 21 years with Wyeth Pharmaceuticals in various departments including Brand, Toxicology, Generic, Life Cycle, Technical Operations and Product Supply (TO&PS) in various roles, including Project Management and Line Management. Prior to Wyeth he worked at Chelsea Labs (now Watson), Tata Pharma and GD Searle.

Kurt Nielsen, Catalent’s senior vice president, Innovation & Growth, said, “We are pleased to welcome Rao to Catalent. He brings with him extensive knowledge of life cycle management, brand and generic products, project management, new product and process development which will help him drive sustainable long-term growth for Catalent.”
Frontage, BSPC Get FDA Approval for Generic Norvasc

Posted on May 4, 2011 @ 09:14 am

Beijing Second Pharmaceutical Co., Ltd. (BSPC) has received FDA approval of its ANDA 090752 for Amlodipine Besylate, a generic form of Pfizer’s Norvasc. BSPC is a China-based generic pharmaceutical company focused on manufacturing ophthalmic dosage forms and oral solid dosages targeted for cardiovascular therapies at its EU and U.S. cGMP-compliant finished product and API facilities.

With this approval, BSPC will become the first Chinese-owned pharma firm to be able to launch an FDA-approved oral solid dose product on the U.S. market. A U.S.-based distribution partner will market the product.

Working with BSPC, Frontage Laboratories, Inc. developed the generic-equivalent formulation and analytical methodologies, provided GMP training and facilities commissioning services, performed technical transfer and scale-up of the developed formulation process, assisted in the execution of the submission batch manufacturing, executed the bioequivalence study, and compiled the electronic ANDA application on behalf of BSPC.

Frontage received approval from the Division of Bioequivalence for BSPC on April 15th, confirming that the Amlodipine Besylate Tablets USP developed by Frontage for BSPC is bioequivalent and therapeutically equivalent to the reference drug Norvasc.


Financial Reports: Charles River Laboratories 1Q11

Posted on May 4, 2011 @ 09:12 am

Charles River Laboratories

1Q Revenues:
$285.8 million (-2%)

1Q Earnings: $35.4 million (+80%)

Comments: Sales were down 7% in the Preclinical Services (PCS) segment to $112.5 million. Research Models and Services (RMS) segment sales were up 1% to $173.4 million. Earnings include an $11.1 million corporate tax benefit in continuing operations related to the disposition of the Phase I clinical business.
Financial Reports: AMRI 1Q11

Posted on May 4, 2011 @ 09:10 am

AMRI

1Q Revenues: $56.9 million (+15%)

1Q Loss: $1.5 million (earnings were $100,000 in 1Q10)

Comments:
Contract revenue in the quarter was $42.9 million, up 10%.
Discovery Services accounted for $10.6 million, down 15%, Development/Small Scale Manufacturing was $10.5 million, up 24%, and Large Scale Manufacturing brought in $21.8 million, up 22%. Recurring royalties in the quarter were up 34% to $14 million. Loss in the quarter includes $400,000 in costs related to the ongoing resolution of the FDA warning letter pertaining to the Burlington, MA parenteral dosage form operations and the impact of restructuring charges associated with a March 2011 reorganization of U.S. operations totaling $600,000.
Executive Moves: ERT

Posted on May 4, 2011 @ 08:58 am

Jeffrey S. Litwin, M.D. has been appointed president and chief executive officer of ERT and a member of the board. Dr. Litwin joined the company in 2000 as senior vice president and chief medical officer and was subsequently promoted in December 2005 to executive vice president and chief medical officer.

Dr. Joel Morganroth, who had served as interim president and chief executive officer, said, "After a thorough national search by Heidrick and Struggles, our board selected Dr. Litwin, an internal candidate, as the most qualified person to lead ERT. Jeff brings to ERT knowledge of the clinical research domain that is our core business, and also experience in the adjacent markets of Phase IV safety surveillance and healthcare in which ERT's assets will be employed. All of our employees look forward to continuing to work with Jeff to enhance ERT's operational successes and strategy."

Dr. Litwin oversaw ERT's global cardiac safety operations for seven years and was instrumental in implementing EXPERT, ERT's digital operating system. Dr. Litwin also serves on the DIA Annual Meeting planning committee, the Applied Clinical Trials Editorial Board, and the Board of Directors of the Metrics Champion Consortium.

The board also elected Elam M. Hitchner, III to succeed Dr. Morganroth as chairman. Mr. Hitchner has served since April 2010 as the lead independent director of the board.

Akorn To Acquire AVR

Posted on May 3, 2011 @ 09:24 am

Akorn, Inc. has entered into an agreement to acquire Advanced Vision Research, Inc. (AVR), an OTC ophthalmic company, for $26 million in cash. AVR develops and markets eye care products under the brands TheraTears and MacuTrition for dry eyes, eyelid hygiene, contact lens comfort and eye nutrition. Last year, AVR had sales of $20 million.

Akorn also plans to launch a new Consumer Health Division to enter the $1.2 billion OTC eye care market. Bruce Kutinsky, Pharm. D., will serve as president of the new division. Mr. Kutinsky joined Akorn as senior vice president of corporate strategy in 2010. Prior to joining Akorn, he served as vice president of strategic solutions at Walgreens. Mr. Kutinsky also held various senior management positions at Option Care, Inc., which was acquired by Walgreens in 2007.

Raj Rai, chief executive officer of Akorn, said, “AVR is a great strategic platform to expand into the OTC eye care market. We have had a positive relationship with AVR for several years as a primary contract manufacturer. With the acquisition, we can add value in future growth as we have an existing sales infrastructure that markets products to ophthalmologists, optometrists, and retailers nationwide complementing AVR’s sales initiatives.”
Financial Report: PAREXEL 3Q10

Posted on May 3, 2011 @ 09:23 am

PAREXEL 3Q10

3Q Revenues: $301.4 million (+4%)

3Q Earnings: $15.7 million (+23%)

YTD Revenues: $901.6 million (+8%)

YTD Earnings:
$50.4 million (+76%)

Comments: Consolidated service revenue for the quarter was $227.0 million in Clinical Research Services (CRS), $34.1 million in PAREXEL Consulting and Medical Communications Services (PCMS), and $40.3 million in Perceptive Informatics, Inc. Backlog at the end of March was approximately $3.2 billion, up 34%. Results in the quarter were adversely impacted by lower Early Phase revenue in the CRS unit, slower revenue conversion from backlog related to strategic partnerships, and client delays on some large projects. The company had a tax benefit in the quarter of approximately $900,000. Restructuring charges in 3Q10 included $0.5 million of facility-related costs and $3.6 million in severance costs and YTD included $0.4 million of depreciation on abandoned facilities, $5.8 million of facility-related costs and $7.2 million in severance costs.
Icagen, Pfizer Enter Research Pact With Yale

Posted on May 3, 2011 @ 09:21 am

Icagen and Pfizer have entered into a collaboration with the Yale School of Medicine to investigate potential new pain compounds identified by Icagen and Pfizer in their existing collaboration.

P. Kay Wagoner, Ph.D., chief executive officer of Icagen, said, “We are very pleased that Yale researchers Stephen Waxman, M.D. and Sulayman Dib-Hajj M.D. have agreed to work with us and our partner Pfizer in the study of Nav1.7 channels from inherited erythromelalgia (IEM) patients. Drs. Waxman and Dib-Hajj are among the world’s leading researchers in the role of sodium channels in pain. The studies we are jointly undertaking should help us better understand how modulating Nav1.7 channels in IEM patients may reduce the extreme pain experienced by these patients. This information may additionally assist our broader efforts to find novel sodium channel treatments for patients with various pain conditions.”
Althea, Biotest In Commercial Filling Pact

Posted on May 3, 2011 @ 09:20 am

Althea Technologies has entered into a commercial supply agreement with Biotest Pharmaceuticals under which Althea will fill commercial drug products to supply the U.S. market. The products will be filled in Althea’s new commercial manufacturing facility in San Diego, CA.

“We are very pleased to be selected by Biotest as their strategic partner and commercial filler,” said Rick Hancock, president, Althea Technologies. “We are looking forward to supporting Biotest as their commercial manufacturing partner.”
Financial Reports: Pfizer 1Q11

Posted on May 3, 2011 @ 06:20 am

Pfizer 1Q

1Q Revenues: $16.5 billion (flat)

1Q Earnings: $2.2 billion (+10%)

Comments: Revenue figures for 1Q11 include two months of King Pharma revenues (Feb. 1 to March 31, 2011), totaling $224 million. Primary care revenues dropped 7% to $5.4 billion, Speciality Care was up 12% to $3.9 billion, Established Products fell 15% to $2.4 billion, Emerging Markets grew 10% to $2.2 billion, and Oncology was down 14% to $311 million. Primary Care was affected by loss of Lipitor patent protection in Canada and Spain, and Aricept in the U.S. Established Markets was hurt by loss of patent protection for Effexor, Protonix and Zosyn. Lipitor sales dropped 13% to $2.4 billion in the quarter, Lyrica sales rose 14% to $826 million, Celebrex posted 4% growth to $591 million, and Enbrel gained 8% to $870 million. Effexor revenues dropped 72% to $204 million.
Teva to Acquire Cephalon

Posted on May 2, 2011 @ 09:14 am

Teva has agreed to acquire Cephalon for approximately $6.8 billion in cash. The transaction is expected to close in 3Q011. Last month, Valeant launched a hostile bid for Cephalon at $5.7 billion. Teva’s offer equates to $81 per share of Cephalon, while Valeant was offering $73 per share.

The combined company will have complementary commercial, R&D and operational capabilities and will provide a broad spectrum of specialty branded products in niche therapeutic areas including CNS, oncology, respiratory and pain management. The combined branded portfolio represents approximately $7 billion in sales, with a pipeline including more than 30 late-stage compounds.

“We are embarking today on a new and exciting future for Teva’s branded business, and we are delighted that we will be working together with the Cephalon team,” said Shlomo Yanai, president and chief executive officer of Teva. “This is transforming for Teva’s branded business, as it will help us to deliver on our strategic goal of creating a diversified, multi-faceted company. We have been following Cephalon for a long time and are very happy with the opportunity to join forces. Our significantly broader portfolio will permit marketing and sales synergies and enhance profitability. We look forward to welcoming our colleagues at Cephalon to the Teva family.”

“Cephalon’s merger with Teva is the result of a rigorous process that included a review of a wide-range of strategic options undertaken by Cephalon’s board of directors and management team to maximize value and deliver significant returns to shareholders,” said Kevin Buchi, chief executive officer of Cephalon. “By joining forces with Teva, we will benefit from their scale, worldwide reach and operational excellence, allowing us to further pursue our shared goals of delivering new, innovative therapies to help patients around the world. Teva shares our strong commitment to R&D, and we believe our pipeline will thrive under their leadership. We look forward to working with the Teva team to ensure a smooth transition and complete the transaction as expeditiously as possible.”
Grifols, Talecris Sign Consent Agreement for Merger

Posted on May 2, 2011 @ 09:12 am

Grifols, S.A. and Talecris Biotherapeutics Holdings Corp. have signed a consent agreement with the U.S. Federal Trade Commission (FTC) outlining the conditions for Grifols’ acquisition of Talecris. Grifols has agreed to the sale of select assets and has entered into certain commercial, lease and manufacturing agreements with the Italian company Kedrion for as many as seven years.

Kedrion and Grifols will have a contract manufacturing agreement to fractionate and purify Kedrion’s plasma and to deliver IVIG and Albumin under Kedrion’s private label, and Factor VIII under the trade name Koate, for sale in the U.S.

Grifols will sell its Melville, N.Y. fractionation facility to Kedrion and Grifols will manage the facility for as long as four years under a lease agreement with Kedrion. Grifols will also sell Talecris’ U.S. FVIII business (Koate) and two Talecris plasma collection centers to Kedrion.

The consent agreement remains subject to approval by the FTC and until the acquisition is finalized, both companies remain independent and will conduct business as usual.
A+ Secure Packaging Passes FDA Inspection

Posted on May 2, 2011 @ 09:11 am

A+ Secure Packaging’s LaVergne, TN facility has successfully completed a two-day cGMP compliance inspection by the FDA without any form 483 observations being issued.

Ronnie Smith, president of A+ Secure Packaging, said, “It is very gratifying to have the FDA recognize our investment and dedication of our associates in assuring our facility is in compliance with federal cGMPs. The positive results of this audit are a true reflection of the level of Quality our organization is based upon. I am very proud of the talent at A+ and this validation of their efforts.”

A+ Secure Packaging provides custom contract packaging services for the manufacturers of pharmaceutical, OTC, nutraceutical, dietary supplement, animal health, and medical device products.
Executive Moves: Cambridge Major Laboratories

Posted on May 2, 2011 @ 09:10 am

Richard C. (Rick) Proehl bas been appointed vice president of manufacturing at Cambridge Major Laboratories. Mr. Proehl will be responsible for all plant scale manufacturing operations, as well as all engineering and EHS functions. He has more than 30 years of API manufacturing experience and a strong EHS and Quality Compliance background.

“Rick brings a wealth of experience to our team and his focus on quality and execution is a great fit with our company values,” said Brian Scanlan, president and chief executive officer of Cambridge Major. “Rick further structures our rapidly growing API manufacturing business, while building enhanced systems and sustainability across all of our manufacturing assets.”

Prior to joining the company, Mr. Proehl served as the St. Louis site director for Covidien, where he was responsible for the company’s largest API plant and led all aspects of the manufacturing operations, and regulatory compliance of the resident R&D operations, as well as logistics and quality support of a remote API facility.

During his 30-year career at Covidien, Mallinckrodt, he held positions including radiopharmaceuticals production manager, plant manager, and general manger, peptides.

April 2011

CTI Opens Spain Office

Posted on April 29, 2011 @ 08:38 am

CTI Clinical Trial and Consulting Services (CTI) has formed CTI Clinical Trial and Consulting Services Spain, SL. This new geographic office, located in Madrid, will allow CTI to better meet the needs of its sponsors throughout Europe. According to a company statement, “Spain has always been a key contributor to the clinical research field and, in recent years, has seen an increase in the number of clinical trials conducted in the country.” The Madrid office will complement CTI's clinical trial services offering in western Europe. The company's EU Team, with headquarters in Ulm, Germany, has managed clinical trials in multiple EU countries for many years.

“The pharmaceutical and biotechnology industries continue to be very interested in conducting clinical research in Spain due to the quality of the clinical sites, the investigators, and the data they provide,” said Timothy J. Schroeder, CTI's president and chief executive officer. “Our therapeutic areas mesh well with the type of research conducted in Spain and our new office will help us better meet the needs of our sponsors.”
Executive Moves: PharmaNet Development Group

Posted on April 29, 2011 @ 08:34 am

Valerie Palumbo has been named senior vice president, Corporate Quality Assurance at PharmaNet Development Group.
Ms. Palumbo has more than 20 years of experience in the development and implementation of quality assurance programs in the FDA-regulated drug and medical device industries. Her experience includes oversight of preclinical, clinical, and clinical supplies manufacturing activities. In addition, Ms. Palumbo has significant experience in the globalization of policies and procedures that drive company-wide compliance, and in the implementation and enhancement of computer system validation and 21 CFR Part 11 compliance processes.
"We are very pleased to have Valerie join us," said Thomas Newman, MD, President, PharmaNet Development Group. "Valerie brings deep experience in developing global programs that will enhance our quality processes and augment our existing compliance programs."
Executive Moves: Absorption Systems

Posted on April 29, 2011 @ 08:32 am

Sid Bhoopathy, Ph.D. has been named to chief operating officer at Absorption Systems. He has been with the company since 2004 and previously served as vice president of operations. Before coming to the company, Dr. Bhoopathy was a research scientist at PPDI.

He has overall responsibility for strategic leadership and day-to-day operations in sales and marketing, as well as planning, execution and delivery of contract services (ADMET studies). Dr. Bhoopathy is based at the company’s Exton, PA headquarters.

“Sid has proven his considerable value to the company in his seven years with us, and has been rewarded with steadily increasing levels of responsibility along the way,” said Patrick M. Dentinger, president and chief executive officer of Absorption Systems. “As chief operating officer, his passion, focus and drug development savvy will help us execute our shared vision for the future of Absorption Systems.”
Financial Reports: Merck 1Q11

Posted on April 29, 2011 @ 08:25 am

Financial Reports: Merck

1Q Revenues: $11.6 billion (+1%)

1Q Earnings: $1.0 billion (+248%)

Comments: The company took $1.8 billion in one-time charges in 1Q11, including a $500 million payment to Johnson & Johnson to settle Remicade/Simponi arbitration and $302 million in in-process R&D writeoffs; it had $2.3 billion in one-time charges in 1Q10. Pharma revenues grew 2% to $9.8 billion, led by Singulair (+14% to $1.3 billion), Remicade (+12% to $753 million) and Januvia (+45% to $739 million). Cozaar/Hyzaar revenues dropped 46% to $426 million due to generic erosion. Combined sales of the Januvia/Janumet franchise crossed $1 billion for the quarter.
Particle Sciences, Celanese in Drug-Eluting Device Pact

Posted on April 29, 2011 @ 08:09 am

Particle Sciences Inc. (PSI) and Celanese EVA Performance Polymers, a supplier of ethylene vinyl acetate (EVA) into pharmaceutical applications, are collaborating to provide PSI with preferred access to VitalDose™ EVA polymers for early-stage projects.

Andrew Loxley, PSI's director of New Technologies, remarked, "With combination products — devices that deliver drugs — there are multiple parties involved including the innovator, the API supplier, the development group and the polymer supplier. All parties want to ensure a quality product. Particle Sciences and Celanese EVA Performance Polymers have been collaborating for a number of years and, because of that relationship, are now in a position to expedite the process."

Jamie Beggs, marketing development manager, Celanese EVA Performance Polymers, commented, "We are committed to becoming the premier EVA excipient producer and have been providing EVA technology for medical applications for years. Our VitalDose brand delivers the reliable performance required for pharma applications combined with in-depth technical expertise and comprehensive regulatory knowledge. This partnership is a testament to the degree to which we have developed confidence in Particle Sciences' capabilities and their focus on quality. With their capabilities in prototyping, characterization, experience with controlled and highly potent substances and cGMP facilities, they have consistently delivered innovation to our customers."

Robert Lee, vice president Pharmaceutical Development at PSI, noted, "Combination products have unique development challenges. For each project, it's important that we start with an open mind as to polymer choice and device architecture. For our EVA needs, we are extremely pleased to be aligned with Celanese EVA Performance Polymers, the group we believe to be most appropriately addressing this market."
Velesco, Vindonwestech in Services Alliance

Posted on April 29, 2011 @ 07:54 am

Velesco has partnered with stability storage provider Vindonwestech, Inc. to enhance its drug formulation development program and clinical trial manufacturing services.

Velesco supports early stage drug development projects from two locations in Plymouth and Kalamazoo, MI with contract analytical and drug formulation services, as well as cGMP clinical supplies for non-sterile dosage forms. Vindonwestech, Inc. provides services for both CROs and pharmaceutical manufacturers, facilitating cGMP storage of biological and pharmaceutical materials over a wide array of temperature and humidity.

Vindonwestech also designs, manufactures and installs a wide range of standard and custom controlled environment room systems, validated to meet the demanding requirements of the pharmaceutical, medical, biological and healthcare industries.

Patrick Jackson, director of Vindon, commented, “Vindonwestech is pleased to be associated with Velesco as Vindonwestech is particularly committed to providing storage services and equipment strengthening Velesco’s ability to deliver a first class stability program.”

Shirley Smith, Quality Assurance director at Velesco noted, “the Vindonwestech facility is impressively designed and equipped. A Velesco and Vindonwestech collaboration assures a strong cGMP quality program and clients can be confident their clinical trial materials will exceed FDA compliance requirements.”
Financial Report: Bristol-Myers Squibb 1Q11

Posted on April 28, 2011 @ 10:17 am

Bristol-Myers Squibb 1Q11

1Q Revenues: $5.0 billion (+4%)

1Q Earnings: $986 million (+33%)

Comments:
U.S. sales were up 5% to $3.3 billion in the quarter. International sales increased 3% to $1.8 billion (1% excluding foreign exchange impact). Plavix sales were up 6% to $1.8 billion. Sustiva Franchise sales were $343 million (+2%). Baraclude sales were $275 million (+27%). Sprycel sales were up 31% to $172 million. Orencia sales were up 18% to $199 million. Abilify sales were $624 million (+1%). Reyataz sales were $366 million (-2%). R&D expenses increased 3% to $935 million in the quarter.


Financial Report: Sanofi-Aventis 1Q11

Posted on April 28, 2011 @ 10:15 am

Sanofi-Aventis 1Q11

1Q Revenues:
$9.3 billion (-2%)

1Q Earnings:
$1.7 billion (-26%)

Comments:
Lantus sales were up 13% to $1.3 billion in the quarter. Lovenox sales were down 27% to $821.9 million; Taxotere sales were down 32% to $538.5 million; and Plavix sales were down 14% to $682.3 million, due to generic competition, as well as austerity measures in EU and healthcare reform in the U.S. Eloxatin sales were up 173% to $265.0 million and Multaq sales were up 154% to $88.8 million. Results include a non-recurring charge of $458.2 million related to Merial assets. Revenues were also impacted by declining A/H1N1 sales compared to 1Q10.
Financial Report: Genzyme 1Q11

Posted on April 28, 2011 @ 10:14 am

Genzyme 1Q11

1Q Revenues: $1.0 billion (+7%)

Comments: Personalized Genetic Health business grew 11% to $436.9 million. Myozyme / Lumizyme sales grew 47% in the quarter to $126.8 million. Cerezyme sales were $183.8 million (+3%). Sales of Fabrazyme were down 23% to $40.9 million, reflecting supply constraints. The company’s Hematology and Oncology business grew 7% to $166.5 million, driven by U.S. growth of Clolar, continued market penetration of Mozobil, and growth of Thymoglobulin. Sales of Renvela and Renagel grew 14% to $187.4 million. Sales of Thyrogen were down due to supply shortages caused by manufacturing constraints. Genzyme was acquired by Sanofi-Aventis on April 8, 2011.
Nautic Acquires Omnicare Clinical Research

Posted on April 28, 2011 @ 10:12 am

Nautic Partners, LLC, a private equity firm based in Providence, RI, has acquired Omnicare Clinical Research (CR) from its parent company, Omnicare, Inc. With added support from Nautic, Omnicare CR has a two-year plan to advance the company and anticipates added growth among its specialized business units including early phase, Phase II/III, late phase, medical device, technical services and pharmaceutics.

“Our new affiliation with Nautic is very exciting for all of us at Omnicare CR. This marks a new era for our business that will provide us the ability to more efficiently make vital, strategic decisions, placing us in control of our own destiny,” said Dr. James M. Pusey, president and chief executive officer of Omnicare CR. “The group in the best position to benefit from this reorganization is our current and future customer base. With our renewed strength, Omnicare CR will be able to deliver an even higher level of customer service while maintaining the teams currently in place who support our customers on a day-to-day basis.”

Nautic’s managing director, Chris Crosby, said, “It was the 900 capable, intelligent people of Omnicare CR, including James Pusey and his leadership team, who initially interested Nautic in the company as a potential investment opportunity. Once we looked at the financials, it was evident that this was a healthy company with great potential in a growing market. Nautic will fully support Omnicare CR on a strategic level and with additional capital for growth. We have complete confidence that with our added support, company leadership will maximize efforts around the great work that has already being done, adding to Omnicare CR’s profitability.”
CIT Acquires LAB Research

Posted on April 28, 2011 @ 10:10 am

Applied Biology Company (ABC), the holding company of CIT Safety & Health Research Laboratories (CIT), has acquired the assets of LAB Research, Inc., consisting of three facilities located in Canada, Denmark and Hungary.

The newly created CIT-LAB group will have consolidated sales of $103 million and 830 staff across five sites in France (Evreux and Saint-Nazaire), Canada (Laval), Denmark (Lille Skensved) and Hungary (Veszprém). The financial details were not disclosed.

CIT has more than 40 years of experience providing preclinical contract research. The CIT-LAB group expands services in North America with LAB Research’s facilities in Canada. The Scandinavian and Central Europe facilities are also a key asset and will allow closer support for more customers.

“With the acquisition of Lab Research, we seized a major opportunity to create a global player serving the pharmaceutical, biotechnology and chemical industries. At a time when the biggest industry companies are turning to global outsourcing agreements, the new CIT-LAB group will be a partner of choice thanks to its ability to carry out a broader range of studies and to provide scientific synergies between facilities,” said Dr. Jean-François Le Bigot, CIT and ABC executive chairman.
Bosch Acquires OYSTAR Subsidiaries

Posted on April 27, 2011 @ 09:55 am

Bosch signed agreements to acquire Hüttlin GmbH and Manesty Ltd., subsidiaries of OYSTAR Holding GmbH. Hüttlin, based in Schopfheim, Germany, produces specialist drying and granulation equipment, from powder to the production of pharmaceuticals. Manesty, based in Knowsley, near Liverpool, UK, specializes in tablet presses and coaters. Financial terms were not disclosed.

In 2010, the two companies generated sales of 49 million euros, with the majority of sales in Europe. Hüttlin employs 80 people in Germany and Manesty has 110 associates in Great Britain.

“The two companies are important stepping stones in the expansion of pharmaceuticals process technology at Bosch,” said Friedbert Klefenz, president of the Bosch Packaging Technology division. “They support the strategic alignment of the division by complementing the upstream value-added chain. This is a further step toward expanding the division to become a full-service provider. This move complements our primary packaging portfolio.”

“In selling Hüttlin and Manesty, OYSTAR is continuing its strategic focus on the primary and secondary packaging business,” said Tom Graf, the chairman of the board of management of the OYSTAR Group. “At the same time, having Bosch as their new owner equips our subsidiaries Hüttlin GmbH and Manesty well for the future. The companies can work together to extend their activities in the area of pharmaceuticals process technology, and successfully continue their growth course.”
Financial Report: GlaxoSmithKline 1Q11

Posted on April 27, 2011 @ 09:53 am

GlaxoSmithKline 1Q11

1Q Revenues:
$10.5 billion (-9%)

1Q Earnings: $3.3 billion (flat)

Comments:
Pharmaceutical sales were $8.4 billion in the quarter (-12%). Avandia sales were down 45% to $145 million. Seretide/Advair sales were flat at $2.0 billion. Flixotide/Flovent sales were $323 million (+6%). Valtrex sales were $144 million (-48%), as generics ate away at its base. Lamictal sales were $182 million (-3%). Avodart sales were $266 million (+23%). Lovaza sales were $203 million (+22%). Augmentin sales were $299 million (+20%). Vaccine sales were $1.2 billion, down 5%. Pandemic flu vaccines sales were $8.0 million in the quarter, compared to $1.1 billion in 1Q10.

Executive Moves: AAIPharma Services

Posted on April 27, 2011 @ 09:52 am

Paul Maffuid has been appointed executive vice president of operations at AAIPharma Services. Dr. Maffuid will have responsibility for the company’s drug product development services functions.

Dr. Maffuid has 27 years of pharmaceutical and biopharmaceutical product development experience. His oversight has included chemical and formulation development, manufacturing, analytical control functions and drug metabolism teams that successfully influenced the discovery and transition of therapeutics through clinical development and commercial launch.

Most recently, Dr. Maffuid served as president of Biopharmalogics, Inc., a provider of drug product consulting services to the life science industry. He has held leadership roles at Arena Pharmaceuticals, Amylin Pharmaceuticals, Magellan Laboratories, Cabrillo Laboratories and Glaxo Research Institute.

“AAIPharma Services is fortunate to have someone with Paul’s experience, expertise and vision to join our team,” said Pat Walsh, chief executive officer. “He will work closely with our leadership team and business groups in aligning our significant scientific resources to better serve our clients.”
Financial Report: PPD 1Q11

Posted on April 27, 2011 @ 09:51 am

PPD 1Q11

1Q Revenues: $346.8 million (-9%)

1Q Earnings: $17.2 million (-54%)

Comments: Clinical Development Services revenue was $279.7 million in the quarter (+11%) and income from operations was $46.5 million, up from $27.0 million in 1Q10. Laboratory Services revenue was $76.5 million (+3%). Income from operations for this segment was $6.0 million, down from $9.5 million in 1Q10. Gross authorizations for the quarter totaled $639.5 million. Backlog at March 31, 2011, was $3.6 billion. Contract cancellations and adjustments were $174.1 million in the quarter.
Executive Moves: Cetero Research

Posted on April 27, 2011 @ 09:49 am

James “Jay” Dixon has been appointed senior vice president of Quality and Compliance at Cetero Research. Mr. Dixon will lead the Quality and Compliance team, ensuring Cetero’s commitment to quality provides its clients with dependable and accurate results. Mr. Dixon has more than 25 years of experience in the pharmaceutical, biotechnology and CRO industries.

“We are thrilled to have someone of Jay’s caliber joining the Cetero team,” said chief executive officer Troy W. McCall, Ph.D. “Cetero considers quality and compliance to be the utmost priority. Jay’s qualifications and background will undoubtedly help raise Cetero’s benchmark for quality to an unprecedented new level.”

Most recently, Mr. Dixon led the quality and compliance efforts for MedImmune, as vice president of GxP Quality Compliance. Prior to that, he served as vice president of Global Quality Assurance and Business Process Improvement – Six Sigma, at Covance Central Laboratory Services. Mr. Dixon also held quality-focused leadership positions at Abbott Laboratories, Triangle Pharmaceuticals (now Gilead Sciences), PAREXEL International, ClinTrials Research and Glaxo Wellcome.
MPI Research Implements Gyrolab xP

Posted on April 27, 2011 @ 09:47 am

MPI Research has acquired and implemented a Gyrolab xP workstation from Gyros AB into its time-critical project workflows. Gyros provides microfluidic technologies to miniaturize and automate immunoassays.

Alan Breau, MPI’s vice president for Bioanalytical/Analytical Services said, “Data from immunoassays underpin many critical decisions within complex project workflows. Our goal as a CRO is to deliver high quality results as rapidly and cost-effectively as possible to our clients in the biopharmaceutical industry. The automated, precise nanoliter-scale immunoassay platform from Gyros enables us to quickly develop project specific biomarker, pharmacokinetic (PK) and immunogenicity assays and to easily transfer the running of established assays thereby freeing staff for other tasks. We believe that this investment will significantly impact the cost-efficiency as well as the turnaround time of our preclinical and clinical studies.”

Erik Walldén, chief executive officer at Gyros, said, “With major biopharmaceutical companies using our platform to increase workflow efficiency, it is extremely pleasing that a growing number of their service providers are following suit. We have seen several examples of highly successful collaborations where both parties have benefited from increased productivity overall and noted the ease with which assays can be transferred between sites. This purchase by a well-established company such as MPI Research reflects the growing acceptance of our nanoliter-scale immunoassay platform within the industry.”
Pii Expands Manufacturing Capabilities

Posted on April 26, 2011 @ 08:55 am

Pharmaceutics International Inc. (Pii) has added an MG2G140 capsule filler to its solid oral GMP manufacturing area, expanding its existing commercial manufacturing capabilities. The MG2 G140 capsule filler has an output rate of as many as 140,000 capsules per hour and can dose powder and pellets.

Steve King, senior vice president of Pii said, “Expanding our large-scale manufacturing capabilities with the addition of the MG2 G140 demonstrates Pii’s commitment to enhancing and growing the commercial services provided to our customers. This new capability allows us to better meet the needs of customers in the late and commercial stages of drug development.”

Pharmacyclics Achieves HDAC Milestone

Posted on April 26, 2011 @ 08:53 am

Pharmacyclics, Inc. has received a $7 million milestone payment from Les Laboratoires Servier (Servier) for its histone deacetylase (HDAC) inhibitor, PCI-24781 / S 78454. The companies began collaborating in April 2009. Servier has conducted several Phase I/II trials in solid tumors and hematologic malignancies and is now focused on its Phase II programs to establish a registration pathway for PCI-24781 / S 78454.

“Servier is delighted to work with Pharmacyclics under this partnership,” said Emmanuel Canet M.D., Ph.D., Servier’s president, R&D. “The molecule PCI-24781 / S 78454 has performed well in a variety of early stage trials and exceeds our expectations. We plan to further expand the clinical development of PCI-27481 / S 78454.”

Mr. Robert Duggan, Pharmacyclics chief executive officer and chairman, said, “We are very pleased with the progress of PCI-24781 / S 78454 and the alliance with Servier. We are looking forward to work closely with our partner to advance this molecule to the market.”
Executive Moves: Harlan Laboratories

Posted on April 26, 2011 @ 08:52 am

Dr. Manuela Leone has been appointed president of contract research services (CRS) for Harlan Laboratories, Inc. Dr. Leone has more than 18 years of experience, having held senior roles at Pharmacia, Fidia, MDS Pharma Services, Galderma and ICON Clinical Research. In these roles, she was responsible for global businesses as large as $300 million. Prior to her industry experience, Dr. Leone was a practicing pediatrician and an academic for seven years.

“We felt that in order to leverage the work of the past several years, the next leader for Harlan CRS needed to be a strong business leader with a unique combination of scientific, market-facing and operational skills,” said chief executive officer Hans Thunem. “Each of these areas is critical to the proper execution of our CRS strategy in the next 12 to 24 months. Manuela has that unique combination of skills and experiences.”
Executive Moves: Novavax, Inc.

Posted on April 26, 2011 @ 08:47 am

Louis Fries III, M.D., has been appointed vice president, clinical and medical affairs, and Jane Halpern, Ph.D., has been appointed vice president of regulatory affairs at Novavax, Inc.

Prior to joining the company, Dr. Fries was director of global clinical development at GSK Biologicals, North America. Previously, he was vice president, clinical and medical affairs at ID Biomedical Corp. (acquired by GSK in 2005) and senior director of clinical research at NABI.

Dr. Halpern previously served as a staff scientist and regulatory affairs specialist at the Vaccine Research Center of the National Institute of Allergy and Infectious Disease (NIAID), National Institutes of Health. Dr. Halpern also held positions in regulatory affairs at Genocea Biosciences, GSK Biologicals, and ID Biomedical.

“We are excited to welcome these two highly talented senior executives to our company,” said Gregory Glenn, M.D., Novavax’s senior vice president and chief medical officer. ”Each brings extensive experience in the development, clinical testing and registration of influenza and novel vaccines and more than two decades of industry and government experience. Their appointments are timely as we turn our attention to late-stage clinical development and commercialization of our virus-like-particle vaccines to prevent the spread of seasonal and pandemic influenza.”
Pharmatek Adds Spray Drying Capabilities

Posted on April 25, 2011 @ 09:04 am

Pharmatek Laboratories, Inc. has added spray drying to its drug formulation and manufacturing capabilities with the purchase of a Buchi B-290 Mini Spray Dryer for formulation feasibility studies and small-scale clinical manufacture. This technology can be used for both oral and parenteral dosage forms.

“Spray drying is an integral technology in Pharmatek’s toolkit for formulating insoluble compounds. The high degree of control and reduced process steps afforded by this process offer a number of advantages over other formulation techniques: enhanced robustness and reproducibility, and the ability to control and create uniform particle size and stabilize volatile and thermo-sensitive compounds,” said Jeffrey Bibbs, chief executive officer and chief scientific officer of Pharmatek.
Sanofi Gains Menactra Indication for Infants

Posted on April 25, 2011 @ 09:02 am

Sanofi Pasteur, the vaccines division of the Sanofi-Aventis Group, received approval from the FDA for the expanded use of meningococcal conjugate vaccine Menactra (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine), in infants and children 9 to 23 months of age.

The approval was based on results from a Phase II trial and three Phase III trials in more than 3,300 infants that received Menactra vaccine using a two-dose schedule. Results showed that two doses of Menactra vaccine given three months apart elicits an immune response against the serogroups included in the vaccine. The studies also showed that measles-mumps-rubella-varicella vaccine (MMRV) and pneumococcal conjugate vaccine (PCV7) can be administered along with Menactra vaccine in children.

“The approval of Menactra vaccine for infants is a significant advancement toward potentially eliminating the threat of this serious disease in this vulnerable population for included serogroups,” said Michael Decker, M.D., MPH, vice president, scientific and medical affairs at Sanofi Pasteur. “With this approval, it is now possible to help protect persons from 9 months through 55 years of age.”
Bayer, OncoMed Enter Clinical Mfg Pact

Posted on April 25, 2011 @ 09:01 am

OncoMed Pharmaceuticals and Bayer HealthCare have expanded their collaboration under which Bayer will manufacture clinical supplies of a second Wnt inhibitor. Bayer will manufacture the bulk drug substance at its Berkeley, CA clinical manufacturing center to support Phase I testing, which expected to begin in 2012.

“We are pleased to announce this expansion of our partnership with Bayer,” said Paul Hastings, president and chief executive officer of OncoMed Pharmaceuticals. “We continue to make significant progress in our Wnt pathway programs, and this manufacturing agreement underscores the commitment of both parties to collaboratively advance breakthrough anticancer stem cell programs into development.”

“At Bayer we have extensive experience in process development and manufacturing a wide variety of proteins, including complex glycoproteins,” said Harald Dinter, vice president of Global Biologics Development for Bayer HealthCare. “This extension of our partnership with OncoMed to include clinical manufacturing of this additional product candidate is characteristic of our approach to working side-by-side in collaborations to advance novel therapeutic candidates to patient care.”

GVK Bio Licenses Biomarker Database to FDA

Posted on April 25, 2011 @ 09:00 am

GVK Biosciences has extended its Clinical Biomarker Database (GOBIOM) license to the Biomarker Qualification Group of the FDA. The GOBIOM database is a comprehensive collection of clinically evaluated, exploratory and preclinical biomarkers associated with different therapeutic areas reported in global clinical trials. It contains information on 12,000 biomarkers comprising biochemical, genomic, imaging, metabolite, cellular and physiological markers.

Sreeni Devidas, vice president, sales and marketing of Informatics, said, “The collaboration with the FDA helped GVK BIO in developing the safety biomarker content in GOBIOM. The interconnectivity between the organ toxicities to the drug, dose and population was developed with equal emphasis on its preclinical qualification. Biomarker analysis tools were integrated into the database such that the user can make comparative analysis between the biomarkers of their interest.”

Executive Moves: Cytovance Biologics

Posted on April 25, 2011 @ 08:58 am

Bernhard Hampl, Ph.D., has been appointed co-chairman of Cytovance Biologics, Inc. Previously, he served as chief executive officer of Eon Labs and the Sandoz U.S. division of Novartis. Dr. Hampl joined Eon as chief executive officer and president in 1996 and led the company’s growth transformation and subsequent acquisition by Novartis in 2005.

Darren Head, chief executive officer of Cytovance said, “Cytovance has been experiencing rapid business growth and the equity financing from Great Point Partners puts additional muscle on an already strong balance sheet that has no debt. As we expand our capabilities and facility in biologics contract manufacturing in both mammalian and microbial cell cultures for proteins and antibodies in the U.S. and internationally, we wanted to add an admired executive with global biologics and biosimilar manufacturing and marketing expertise. We are honored to have Dr. Hampl as Co-Chairman.”

Financial Report: Amgen 1Q11

Posted on April 21, 2011 @ 09:42 am

Amgen1Q11

1Q Revenues: $3.7 billion (+3%)

1Q Earnings: $1.1 billion (-4%)

Comments: U.S. product sales in the quarter increased 4% to $2.8 billion. International sales were down 1% to $840 million. Aranesp sales were down 7% to $580 million and Epogen sales were down 14% to $535 million, due to decline in demand. Neulasta and Neupogen sales were up 4% to $1.2 billion. Enbrel sales increased 9% to $875 million. Sales of Sensipar / Mimpara were $187 million (+4%). R&D expenses were up 14% to $703 million in the quarter. Sales of Prolia in the quarter were $27 million. U.S. sales of XGEVA were $42 million.
Financial Report: Biogen Idec 1Q11

Posted on April 21, 2011 @ 09:40 am

Biogen Idec 1Q11

1Q Revenues: $1.2 billion (+9%)

1Q Earnings: $308.8 million (+40%)

Comments: Growth in the quarter was primarily driven by Tysabri revenues, up 15% to $251 million, and Avonex sales, up 8% to $642 million. Rituxan revenues from the company’s joint business arrangement with Elan were flat at $256 million for the quarter. Other product revenue in the quarter was flat at $13 million.
Financial Report: Gilead Sciences 1Q11

Posted on April 21, 2011 @ 09:39 am

Gilead Sciences 1Q11

1Q Revenues: $1.9 billion (-8%)

1Q Earnings: $651.1 million (-24%)

Comments:
Sales of Atripla were up 7% to $744.5 million. Sales of Truvada were up 2% to $673.1 million. Viread sales were down 7% to $168.4 million, due to lower sales volume in Brazil. Sales of Letairis were $62.2 million (+12%). Ranexa sales were up 33% to $68.3 million. Other product sales accounted for $147.1 million. Royalty, contract and other revenues from collaborations were $62.5 million in the quarter, down 79%, due to lower Tamiflu royalties from Roche of $11.1 million compared to $246.3 million in 1Q10. Results in the quarter were impacted by the 95% drop in Tamiflu royalties.
Financial Report: ICON 1Q11

Posted on April 21, 2011 @ 09:38 am

ICON 1Q11

1Q Revenues:
$229 million (+5%)

1Q Earnings:
$12.8 million (-42%)

Comments: Gross business wins in the quarter were $329 million, representing a book to bill of 1.43. Net business wins were $257 million with a book to bill of 1.12. Earnings in the quarter were impacted by a $5 million restructuring charge.

ICON, ACRONET Sign Alliance in Japan

Posted on April 21, 2011 @ 09:36 am

ICON and ACRONET Corp. have signed an alliance agreement under which the two companies will collaborate to offer global and Japanese pharmaceutical clients a full range of clinical development capabilities to manage trials both regionally and globally.

ACRONET is headquartered in Tokyo with additional offices in Osaka, Fukuoka and New York. ICON has been operational in Japan since 1995 and offers clinical development services and contract staffing from its offices in Tokyo and Osaka.

Alan Morgan, ICON’s group president, Clinical Research Services, said, “Japan is an important center for clinical research and ICON has a well established presence there. Recent changes in the regulatory landscape mean that an increasing number of Japanese based pharmaceutical companies are looking to run development projects on both a domestic and pan regional basis. The alliance between ICON and ACRONET will benefit clients, who can be assured of a wider range of quality drug development services alongside truly global expertise.”

Shogo Nakamori, ACRONET’s president and chief executive officer said, “The number of global clinical trials involving the triad regions of U.S., EU and Japan has increased gradually in recent years and this trend will continue to accelerate. This is one of the challenging areas for the Japanese pharmaceutical industry and ACRONET is now ready to contribute and support the above challenging areas through this alliance with ICON.”
Financial Report: Elan 1Q11

Posted on April 20, 2011 @ 09:29 am

Elan 1Q11

1Q Revenues: $313.0 million (+1%)

1Q Earnings: $68.2 million (loss of $6.8 million in 1Q10)

Comments: Tysabri revenues were up 23% to $245.2 million in the quarter, offsetting revenue loss from legacy products including Azactam, Prialt, Maxipime and Skelaxin, which contributed $38.7 million in 1Q10. Total revenue from the Elan Drug Technologies drug delivery business was $65.9 million (-14%). Earnings in the quarter include a $78.0 million settlement gain related to Abraxis.
Financial Report: Abbott 1Q11

Posted on April 20, 2011 @ 09:28 am

Abbott 1Q11

1Q Revenues:
$9.0 billion (+17%)

1Q Earnings:
$864.0 million (-14%)

Comments:
Pharmaceutical sales were $3.8 billion in the quarter, up 12%. Humira sales were up 18% to $1.6 billion. Trilipix/TriCor sales were $372 million, up 28%. Kaletra sales dropped 15% to $248 million. Niaspan sales were up 11% to $226 million. Synthroid sales were $145 million, up 18%. R&D expenses were up 27% to $930 million. Medical device sales were $1.2 billion (+11%). Earnings were impacted by restructuring and integration costs for the Solvay Pharmaceuticals acquistion.
Vince & Assoc. CR Completes Pharmacology Expansion

Posted on April 20, 2011 @ 09:26 am

Vince & Associates Clinical Research has opened its newly expanded, 90-bed Clinical Pharmacology Research Unit. The facility features a USP 797-compliant Biosafety cabinet and full-time pharmacy staff, extensive lab areas for the processing of biomarkers and blood samples, as well as strategic alliances for specialized testing.

According to the company, the facility design delivers a “boutique hotel experience for study volunteers and a first-class scientific research setting for the biopharmaceutical industry.” Features include touch-screen entertainment systems, in-house theater room, and individually themed luxury suites.

“The unit is purpose-built for the complex trials our clients require to make earlier drug development decisions and advance their drugs to market more aggressively than ever before. For example, we provide the full technical resources and medical expertise required for Phase I/IIa Proof of Concept (POC) studies which incorporate a single ascending dose (SAD), multiple ascending dose (MAD) and a patient proof of concept study into a single protocol,” said Dr. Brad Vince, the company’s president and medical director.
Gilead, MicroDose Enter RSV Pact

Posted on April 20, 2011 @ 09:26 am

Gilead Sciences and MicroDose Therapeutx have entered into an exclusive worldwide license and collaboration agreement for the development and commercialization of MDT-637, MicroDose’s inhalable small molecule antiviral fusion inhibitor for the treatment of respiratory syncytial virus (RSV).

MicroDose will receive an upfront payment and research funding to support development of MDT-637 through Phase IIa trials, after which Gilead can assume full development responsibility. MicroDose is also eligible to receive additional payments based upon the achievement of certain development, regulatory and commercial milestones, as well as development fees and royalties on potential sales.

“This strategic collaboration is a significant milestone in MicroDose’s vision to develop first-in-class therapies for major unmet medical needs,” said Anand Gumaste, president and chief executive officer of MicroDose. “Given Gilead’s scientific and clinical expertise in virology, this partnership provides a strong validation of the potential for MDT-637 to become an important therapeutic advance for those affected by RSV infection.”

“There is an urgent need to improve upon RSV treatment and care,” said Norbert W. Bischofberger, Ph.D., Gilead’s executive vice president, R&D and chief scientific officer. “We believe this program aligns well with our expertise in both antiviral and respiratory drug development and we look forward to working with the MicroDose team to advance MDT-637 into clinical testing.”
Sensient Pharma Expands Production Facility

Posted on April 20, 2011 @ 09:25 am

Sensient Pharmaceutical Coating Systems has completed the expansion of its pharmaceutical coating production facility, more than doubling manufacturing capacity and equipment dedicated to the pharmaceutical and nutraceutical industries.

Steve Strickland, general manager of Sensient, said, “This expansion signals our commitment to the pharmaceutical coating market and increases our ability to effectively compete for new business. Our clients have responded favorably to our latest pharmaceutical coating innovations and we now have the production capacity to meet their increasing demand.”

Financial Report: Johnson & Johnson 1Q11

Posted on April 19, 2011 @ 09:49 am

Johnson & Johnson 1Q11

1Q Revenues:
$16.2 billion (+4%)

1Q Earnings: $3.5 billion (-23%)

Comments:
Worldwide Pharmaceutical sales were $6.1 billion in the quarter (+8%), with domestic sales down 1% and international sales up 7%. Remicade sales were up 8% to $1.3 billion. Levaquin/Floxin sales were up 17% to $434 million. Concerta sales were up 10% to $362 million. Prezista sales were up 42% to $266 million. Procrit/Eprex sales were down 24% to $397 million. Topamax sales were down 13% to $129 million. Worldwide Consumer sales were $3.7 billion (-2%), with domestic sales down 14%, impacted by the suspension of manufacturing at the McNeil Consumer Healthcare facility in Fort Washington, PA. International sales increased 6%. Worldwide Medical Devices and Diagnostics sales were $6.4 billion (+3%).

Financial Report: Novartis 1Q11

Posted on April 19, 2011 @ 09:47 am

Novartis 1Q11

1Q Revenues:
$14.0 billion (+16%)

1Q Earnings:
$3.4 billion (+2%)

Comments: Pharmaceuticals sales were up 7% to $7.8 billion. Diovan sales were down 3% to $1.4 billion. Exforge sales were $261 million (+28%). Tekturna/Rasilez sales were $131 million (+47%). Galvus sales were up 74% to $132 million. Gleevec/Glivec sales were $1.1 billion (+4%). Lucentis sales were $444 million (+22%). Sales of Xolair were up 34% to $107 million. Sales at the Sandoz unit were $2.3 billion (+16%), driven by recently launched products, enoxaparin (generic Lovenox) and gemcitabine (generic Gemzar), as well as accelerating biosimilars growth outside Germany. Vaccines & Diagnostics sales were down 73% to $371 million due to 2010 A(H1N1) pandemic flu vaccine sales ($1.1 billion). Consumer Health sales were up 11% to $1.6 billion. Alcon sales were $1.9 billion (+12%).
Doe & Ingalls, BioVectra Expand Distribution Pact

Posted on April 19, 2011 @ 09:46 am

Doe & Ingalls and BioVectra have renewed and expanded their partnership agreement. Under the new three-year agreement, Doe & Ingalls will be the exclusive distribution partner for BioVectra bioprocessing reagents in the U.S. and PR.

Doe & Ingalls will provide customers access to BioVectra’s key bioprocessing products, such as Dithiothreitol, TCEP, animal-free IPTG, MPEG reagents and enzymes. It will also provide cGMP-compliant cold storage to maintain stability for many bioprocessing products, from its Jessup, MD and Riverside, CA facilities.
Genmab, Seattle Genetics Expand ADC Pact

Posted on April 19, 2011 @ 09:44 am

Genmab and Seattle Genetics have entered into their second antibody-drug conjugate (ADC) research collaboration under which Genmab has rights to use Seattle Genetics’ ADC technology with HuMax-CD74, an antibody in preclinical development to treat a range of hematological malignancies and solid tumors. Seattle Genetics received an undisclosed upfront payment and has the right to exercise a co-development and co-commercialization option for any resulting products at the end of Phase I development.

Genmab is responsible for research, manufacturing, preclinical development and Phase I evaluation. Seattle Genetics will receive research support payments. If Seattle Genetics selects a product at the end of Phase I, Genmab will receive a payment and the companies would co-develop and share all future costs and profits equally. If Seattle Genetics does not opt in to an ADC product, Genmab would pay Seattle Genetics fees, milestones and royalties on sales.

“The expanded collaboration with Genmab provides us with another opportunity to augment our future ADC product pipeline based on data from a phase I clinical trial,” said Eric L. Dobmeier, Chief Business Officer of Seattle Genetics. “We now have co-development options for four of our collaborators’ ADC programs, reflecting our ability to maximize the potential of our technology through strategic collaborations with organizations that have complementary capabilities.”

Financial Report: Lilly 1Q11

Posted on April 18, 2011 @ 09:39 am

Lilly 1Q11

1Q Revenues: $5.8 billion (+6%)

1Q Earnings: $1.1 billion (-15%)

Comments: Total revenue in the U.S. was $3.1 billion (+1%) primarily due to higher prices, partially offset by lower volume. Revenue outside the U.S. was up 13% to $2.8 billion due to increased volume and the positive impact of foreign exchange. Revenue in the quarter was down $90 million due to the impact of U.S. healthcare reform. Zyprexa sales were up 6% to $1.3 billion. Cymbalta sales were up 13% to $908.8 million. Alimta sales were up 10% to $579.9 million. Gemzar sales dropped 46% due to the impact of generic competition. The company incurred restructuring charges of $76.3 million in the quarter, as well as a $388.0 million in-process R&D charge associated with the Boehringer Ingelheim diabetes collaboration.
Baxter To Acquire Prism

Posted on April 18, 2011 @ 09:37 am

Baxter International has entered into a definitive agreement to acquire Prism Pharmaceuticals. The purchase includes Prism’s Nexterone product portfolio and consists of a $170 million upfront payment at closing and as much as $168 million in future sales milestones, for a potential total of $338 million. Nexterone (amiodarone HCl) is an antiarrhythmic agent approved by the FDA for multiple presentations, including ready-to-use premixed intravenous (IV) bag formulations, vials, and a pre-filled syringe.

Prior to the acquisition agreement, Baxter was Prism’s contract manufacturer for the premixed IV bags using its Galaxy container technology and the prefilled syringe. The transaction, subject to customary closing conditions, is expected to close in 2Q11.

“Nexterone is a great addition to our leading portfolio of premix drugs and solutions for the acute care setting. It offers clinicians a unique, ready-to-use antiarrhythmic agent for critical and time sensitive situations, while also providing convenience to caregivers and value to pharmacists,” said Robert M. Davis, president of Baxter’s Medical Products business. “Based on our strong hospital relationships and familiarity with the product, Baxter is well-positioned to launch the ready-to-use presentations of Nexterone.”

“The development and approval of Nexterone has been Prism’s greatest achievement,” said Warren Cooper, chief executive officer of Prism Pharmaceuticals. “We look forward to Baxter’s success in launching this product, which will benefit clinicians and the patients they serve.”

Financial Report: Amylin 1Q11

Posted on April 18, 2011 @ 09:36 am

Amylin 1Q11

1Q Revenues: $152.7 million (-12%)

1Q Loss: $37.3 million (loss of $38.2 million in 1Q10)

Comments: Byetta sales were $128.0 million (-15%). Collaborative profit sharing, which represents Lilly’s share of Byetta, was $59.9 million for the quarter, compared to $67.9 million for the same period in 2010. Symlin (pramlintide acetate) injection sales were $22.8 million (+1%). Revenues under collaborative agreements were flat at $1.9 million. During the quarter, the company notified its partner Lilly of its intent to draw a $165 million line of credit from Lilly.
Pharmatek Gains DEA Approval

Posted on April 18, 2011 @ 09:34 am

Pharmatek Laboratories has been approved by the U.S. Drug Enforcement Agency (DEA) for the analysis of Schedules I through V controlled substances, adding to its existing license to develop and manufacture drug products containing Schedules IV and V controlled substances.

“Receipt of this additional registration from the DEA demonstrates that we meet the Agency’s stringent requirements, and further validates our facility design, security systems, and procedures for analysis, handling, storage and disposal of controlled substances,” said Jeffrey Bibbs, Ph.D., chief executive officer and chief scientific officer at Pharmatek. ”This registration allows us to perform analytical and stability testing for all controlled-substance drug products within both our non-potent and highly-potent GMP facilities.”
Sanofi-Aventis, Stanford in Research Pact

Posted on April 18, 2011 @ 09:32 am

Sanofi-Aventis has entered a research collaboration through the Stanford University Bio-X program that supports, organizes and facilitates collaborative research projects in the early phases of development.

A Stanford Bio-X and Sanofi-Aventis joint steering committee will fund as many as five programs a year. Sanofi will fund an annual research forum that will bring together researchers from both parties to share knowledge and perspectives on scientific matters and research projects funded through the collaboration.

“Our approach to R&D must ensure we are at the center of the most innovative science, whether inside our own walls or through external partnerships, in order to continue to advance scientific knowledge and address patients’ unmet medical needs,” said Dr. Paul Chew, senior vice president, U.S. chief science officer and chief medical officer, Sanofi-Aventis U.S. ”Stanford is a world-class institution and Sanofi-Aventis is delighted to collaborate with its team of scientists who share a common vision of developing healthcare solutions through scientific discoveries and innovation across various disciplines. Bio-X researchers are exploring novel approaches needed in science today to accelerate the potential for scientific breakthroughs.”
GSK To Shed Non-core OTC Products

Posted on April 15, 2011 @ 09:05 am

GSK plans to divest non-core OTC brands in an effort to focus on its Consumer Healthcare business around a portfolio of priority brands and emerging markets. The focus will be on three categories: Oral Health, Wellness/OTC and Nutrition, with brands such as Sensodyne, Panadol and Horlicks. The company hopes to divest the products by late 2011.

The products to be divested, which are primarily sold in Europe and the U.S., include analgesics such as Solpadeine, BC and Goody’s, vitamin and supplement product Abtei, feminine hygiene treatment Lactacyd, and alli for weight management. These products accounted for approximately 10% or $807 million of GSK’s total Consumer Healthcare sales in 2010.

The company also plans to sell its manufacturing site in Aiken. The brands manufactured at Aiken, include alli, Beano, Ecotrin, Nytol, Phazyme, Sominex and Tagamet/Stomedine.

GSK’s chief executive officer Andrew Witty said, “Consumer Healthcare is a key growth driver for GSK. But it is important that we focus this business around product categories, brands and markets where we have most depth and competitive advantage, with the best prospects for strong growth. This divestment is also an example of our commitment to focus on realizing value and enhancing returns to shareholders.”
Gerresheimer Manufactures Sanofi-Aventis Insulin Pen

Posted on April 15, 2011 @ 09:03 am

Gerresheimer AG began commercial production of ClikSTAR insulin pens for Sanofi-Aventis. The Gerresheimer product incorporates a dosage and application function in addition to the medication packaging. The individual components are manufactured and assembled under clean room conditions at the company’s Pfreimd plant in Germany.

“We are delighted about this Sanofi-Aventis production project because it involves a complex product that demonstrates our leadership in the medical plastic systems market to the pharma industry,” said Uwe Röhrhoff, chief executive officer of Gerresheimer AG.

Pfizer’s Oral JAK Trial Meets RA Endpoint

Posted on April 15, 2011 @ 09:02 am

Pfizer achieved positive results from the ORAL Scan Phase III study of tofacitinib, an investigational oral JAK inhibitor, in patients with moderate-to-severe active rheumatoid arthritis (RA) who had an inadequate response to methotrexate (MTX). Patients were randomized to receive tofacitinib 5 or 10 mg BID or placebo added to background MTX.

The study met all primary endpoints at the 10 mg BID dose, showing statistically significant changes versus placebo in reducing signs and symptoms of RA, reducing the progression of structural damage at six months, improving physical function at three months, and in reaching DAS28-4 (ESR) <2.6 at six months.

For the 5 mg BID dose, the study demonstrated statistically significant improvements versus placebo in at six months, but the difference from placebo in mTSS did not reach statistical significance at six months.
Galapagos Stops Phase II RA Trial

Posted on April 15, 2011 @ 09:01 am

Galapagos NV will discontinue its Phase II trial for GLPG0259 in rheumatoid arthritis (RA) following a planned interim analysis that did not support continuing development of the drug for RA. No serious adverse events or safety signals were reported, but the Interim Review Committee recommended that study be discontinued due to limited efficacy potential. Galapagos plans to complete a full analysis of the data before making a decision on the next steps for GLPG0259, including other indications.

“The innovative trial design used in this Phase II trial enabled quick determination regarding GLPG0259’s potential efficacy in RA. We will now focus on accelerating the development of our other programs and continue to leverage our unique discovery platform to bring novel modes-of-action to the clinic,” said Onno van de Stolpe, chief executive officer of Galapagos.
Merck, J&J Settle Rights Dispute

Posted on April 15, 2011 @ 08:28 am

Merck and Johnson & Johnson have reached a settlement in their dispute over the distribution rights for Remicade and Simponi, nearly two years after J&J requested arbitration in the case.

Merck will give up marketing rights to both drugs in Canada, Central and South America, the Middle East, Asia and Asia Pacific territories. Those markets represented 30% of Merck's Remicade and Simponi revenues. The company will retain exclusive rights in Europe, Russia and Turkey. Merck's total revenues from the two drugs in 2010 was $2.8 billion, of which the relinquished territories accounted for approximately $850 million.

In addition, all profits from Merck's revenues in its remaining territories will be split 50/50 with J&J. Previously, the split was 58/42 and was scheduled to reach 50/50 in 2014. Merck will also make a one-time payment of $500 million to J&J.

The companies' dispute centered around a change-of-control provision in the marketing agreement between J&J and Schering-Plough. Merck's acquisition of SP was structured so as to make SP the acquiring company, despite the fact that it was a fraction of the size of Merck and most of its executives departed the new company. J&J argued that this was a ploy to avoid giving up the rights to Remicade and its followup, and requested arbitration in May 2009.

“We are pleased to have reached this voluntary agreement and look forward to continuing to serve patients in need with Remicade and Simponi throughout Europe, Russia and Turkey,” said Kenneth Frazier, President and Chief Executive Officer of Merck. “The immunology field is a rapidly growing therapeutic area. Merck will have a strong footprint in this category through our significant retained interests in Remicade and Simponi, both of which will be important contributors to our overall portfolio. We also are committed to ensuring a smooth transition for customers and patients in the territories being relinquished, with no impact on product supply.”

J&J's 2010 revenues for Remicade were $4.6 billion, while Simponi accounted for $226 million. Those figures include $1.2 billion in product sales to Merck, for sale in the latter's exclusive territories.
J&J Unit Recalls Topamax Lots Over Smell

Posted on April 14, 2011 @ 09:19 am

The Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. (itself a division of Johnson & Johnson) is voluntarily recalling two lots of Topamax (topiramate) 100mg Tablets, shipped between 10/19/2010 and 12/28/2010, and distributed in the U.S. and PR. The recall includes approximately 57,000 bottles of Topamax, but the company believes there are fewer than 6,000 bottles remaining in the marketplace. The recall follows four consumer reports of an uncharacteristic odor, thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole), a byproduct of a chemical preservative sometimes applied to wood used for storage pallets.

In January 2010, in an effort to reduce the potential of TBA contamination, the company required suppliers to verify that they do not use pallets made from chemically treated wood. An internal investigation is underway with suppliers to evaluate the potential source of this TBA issue and where TBA is entering and impacting the supply chain.

While not considered to be toxic, TBA can generate an offensive odor and a small number of patients have reported temporary gastrointestinal symptoms. No reported adverse events caused by the presence of TBA were related to Topamax. The company doesn’t anticipate a product shortage as a result of the recall.
Financial Report: Roche 1Q

Posted on April 14, 2011 @ 09:18 am

Roche 1Q

1Q Revenues: $12.4 billion (-9%)

Comments: Pharmaceuticals Division sales were down 2% in the quarter. Avastin sales were impacted by regulatory and reimbursement uncertainty in the U.S. for the metastatic breast cancer indication. Lucentis, MabThera/Rituxan, Herceptin, Actemra/RoActemra, Activase/TNKase, Tarceva and Xeloda, performed well in the quarter. The exchange rate impacted sales by 1.1 billion Swiss francs or 9%.

Axcan Acquires Mpex Pharma

Posted on April 14, 2011 @ 09:16 am

Axcan has entered into an agreement to acquire Mpex Pharmaceuticals, Inc. and its lead product candidate, Aeroquin, a new aerosol formulation of levofloxacin. Aeroquin is currently in Phase III development for the treatment of pulmonary infections in patients with cystic fibrosis (CF). Mpex will receive an upfront payment and a series of regulatory and success-based payments, but financial details were not disclosed. The acquisition, subject to customary closing conditions, is expected to close 2H11.

Assets not associated with Aeroquin, including financial and human resources, will be spun out of Mpex and into a newly formed company, which will remain in San Diego. Mpex personnel associated with Aeroquin development will continue to lead the clinical development program along with Axcan.

“Axcan has a long history of developing and commercializing pharmaceutical products for the cystic fibrosis community, as evidenced most recently by ZENPEP,” said Daniel Burgess, president and chief executive officer of Mpex. “We look forward to working with the dedicated team at Axcan to help bring this potentially important new treatment option to patients with CF.”
Watson’s NJ Facility Named Corporate HQ

Posted on April 14, 2011 @ 09:15 am

Watson Pharmaceuticals, Inc. has formally designated its Parsippany, NJ facility as its new corporate headquarters. Watson’s previous corporate headquarters was in Corona, CA and executive offices and commercial headquarters were located in Morristown, NJ.

The company’s new corporate headquarters, within a multi-tenant corporate office campus, totals approximately 148,700 sq. ft. The new facility allows the company to combine operations that were previously in separate facilities in the Morristown, NJ area into a larger space.
West Adds Manufacturing Capacity

Posted on April 13, 2011 @ 09:18 am

West Pharmaceutical Services, Inc. is adding manufacturing capacity for the Daikyo Crystal Zenith 1mL syringe system for biopharmaceutical drug packaging and delivery. According to the company, the syringe system overcomes problems inherent in glass-based systems, such as breakage and glass delamination.

West will add clean room manufacturing environments at its Scottsdale, AZ, facility, capable of producing as many as 20 million units annually. The facility will also handle the warehousing and release of other ready-to-use Crystal Zenith systems, such as vials and bulk drug containers. The company is converting 32,000 sq.-ft. of existing space to include ISO 7 (Class 10,000) clean rooms for automated manufacturing, microbiological and functional testing labs, and additional climate controlled and monitored warehouse space. Completion is scheduled for 4Q11.

“We found a high level of interest in the Crystal Zenith insert needle syringe system during its formal launch at a customer open house in Scottsdale last October,” said Donald E. Morel, Jr., Ph.D., chairman and chief executive officer. “The renovation project will give us the space for additional sophisticated injection molding technologies required for manufacturing Crystal Zenith syringes. These will be needed to support numerous customer stability trials and anticipated scale-up as customers realize the significant benefits of this system.”

Amunix, Biogen In Blood Factor Research Pact

Posted on April 13, 2011 @ 09:15 am

Amunix, Inc. has entered into an exclusive worldwide research collaboration with Biogen Idec to research and develop novel, fully-recombinant blood factors (Factors IX, VIII and VIIa) with improved therapeutic properties. The partnership leverages Amunix's protein half-life engineering expertise using its XTEN technology, with Biogen's capabilities in research, manufacturing and clinical development of recombinant blood factors for hemophilia.

The companies will jointly conduct preclinical research and Biogen will be responsible for clinical development, manufacturing and commercialization of any therapeutic candidates selected. Amunix will receive an upfront payment, R&D funding, and will be eligible to receive milestone and royalty payments for therapeutic candidates chosen by Biogen for development.

"Biogen Idec is pleased to initiate research on this innovative technology in collaboration with Amunix," said Glenn Pierce, senior vice president of Biogen Idec Hemophilia. "We have a long-term commitment to hemophilia. In addition to advancing our current late-stage long-lasting Factor IX and Factor VIII programs, we continue to invest in innovations like XTEN, which have the potential to bring further-improved treatment options to the hemophilia community."

"We are pleased to be collaborating with Biogen Idec, a global leader in hemophilia therapeutics," said Willem 'Pim' Stemmer, Ph.D., chief executive officer of Amunix. "Existing recombinant blood factor products require frequent intravenous infusions and there is strong medical need for products that can be dosed less frequently and more conveniently, and used prophylactically. In addition to further validating our XTEN technology platform, this collaboration with Biogen Idec demonstrates the potential of the Amunix XTEN technology for recombinant products that require manufacturing in mammalian cells."
Takeda Cambridge, Dimerix In Second GPCR Pact

Posted on April 13, 2011 @ 09:13 am

Dimerix Bioscience Pty Ltd. has entered into a second research program with Takeda Cambridge Ltd., a UK based subsidiary of Takeda Pharmaceutical Co. This new program is in addition to the companies’ April 2010 research collaboration.

Dimerix is a preclinical stage company developing a pipeline of lead products with highly specific activity and reduced risk of off-target effects. Under the new agreement, Dimerix will continue to use its GPCR-HIT platform and G Protein-Coupled Receptors (GPCRs) expertise to form complexes to work with additional undisclosed Takeda targets.

Mark Carlton, president of Takeda Cambridge Ltd. said: “We are impressed by Dimerix’s achievements over the last 12 months and with the depth of information we have obtained by accessing the power of their GPCR-HIT platform. We have seen that the insights generated using GPCR-HIT provide us with an important extension to our GPCR drug discovery efforts. We are very pleased to be able to expand our efforts with Dimerix.”

Tim Grogan, chief executive officer of Dimerix, said: “We are very pleased with this further expansion of our relationship with Takeda Cambridge. The relevance of our GPCR-HIT platform to the drug discovery and development process and our insights into the formation of complexes between G Protein-Coupled Receptors have been recognized again through this partnership with Takeda Cambridge.”

Access Enters RNAi Delivery Pact

Posted on April 13, 2011 @ 09:11 am

Access Pharmaceuticals, Inc. has entered into an agreement with a major pharmaceutical company to use its CobaCyte and CobOral technology for the targeted delivery of RNAi therapeutics. Access will provide CobOral and CobaCyte siRNA formulations for evaluation of gene knockdown following oral and intravenous administration. According to Access, any successful formulation developed will be jointly owned and subject to a subsequent full licensing agreement. Terms of the agreement were not disclosed.

"We have made great progress in our CobOral and CobaCyte siRNA delivery programs over the past year, demonstrating the efficiency and safe delivery needed for a viable RNAi therapeutic," said Jeffrey B. Davis, president and chief executive officer, Access Pharmaceuticals, Inc. "The signing of this agreement serves as further validation of our previous work related to our CobaCyte technology's unique ability to deliver inactivated siRNA particles to disease target sites.We believe our innovative approach is well-suited for this pharmaceutical company and look forward to the collaborative work ahead."
Pieris, Daiichi Sankyo In Anticalin Development Deal

Posted on April 12, 2011 @ 09:07 am

Pieris AG has entered into a collaboration and license agreement with Daiichi Sankyo Co. Ltd., under which Pieris will apply its Anticalin scaffold technology to discover novel Anticalins against two Daiichi Sankyo targets. Based on Pieris’ discovery and achievement of preclinical development milestones for lead Anticalin drug candidates, Daiichi Sankyo will assume responsibility for further development and marketing of the Anticalin compounds.

Pieris will receive more than $10 million upfront as well as research funding and payments for the achievement of preclinical, regulatory and commercial milestones. Pieris is eligible to receive more than $144.5 million per target in license fees, funding and milestones upon full commercialization, as well as royalties on sales from marketed Anticalins resulting from the collaboration. Daiichi Sankyo will have exclusive marketing rights worldwide for all products.

"Pieris stands in a unique position as an enabling company in the targeted therapeutics space when traditional biological approaches are untenable," said Stephen Yoder, chief executive officer of Pieris. "Our deal with Daiichi Sankyo demonstrates yet again the high value of the Anticalin technology and we're extremely proud to count Daiichi Sankyo among the growing list of industry leaders who are our collaboration partners."
Novartis Discontinues Tasigna in GI Cancer

Posted on April 12, 2011 @ 09:06 am

Novartis AG is discontinuing development of Tasigna as a treatment for cancerous tumors of the gastrointestinal tract. According to the company, an independent data-monitoring committee recommended discontinuing a late-stage trial comparing Tasigna and Gleevec as a first-line treatment of gastrointestinal tumors after interim results showed that patients taking Tasigna were unlikely to live longer than those taking Gleevec, the current standard of care.

Tasigna is approved in the EU, Switzerland and Japan as a treatment for chronic myeloid leukemia.
Executive Moves: NSF-DBA

Posted on April 12, 2011 @ 09:03 am

NSF-DBA has added five pharmaceutical experts to provide consulting and in-house training services to help companies comply with international regulations and improve quality management systems.

Ed Arling, formerly an investigator with the State of Illinois and the FDA, has more than 30 years experience leading quality assurance and regulatory compliance programs for pharmaceutical companies including Pharmacia, Pfizer and Amgen. He currently focuses on quality system assessments, pre-approval inspection readiness, deviation and CAPA (corrective and preventive action) management and related regulatory activity.

Peter H. Calcott, Ph.D., former chair of the Biotechnology Industry Organization Regulatory Affairs committee, has more than 30 years of experience in the pharmaceutical industry having held senior positions in quality, R&D, regulatory affairs, process development and manufacturing at Chiron, Immunex, SmithKline Beecham, and Bayer.

Stan Cryz Ph.D., a specialist in the area of bacterial and viral vaccine development, characterization and clinical evaluation, has more than 30 years of experience in R&D and biologics manufacture. Dr. Cryz most recently served as deputy director of development and production for MassBiologics, a manufacturer of vaccines and biologics in the U.S.

Matt Krsulich M.S. is an analytical chemist and pharmacologist with 30 years of pharmaceutical quality management experience. Mr. Krsulich previously managed QC operations and regulatory CMC (Chemistry Manufacturing Controls) projects at Pfizer and has experience with global GMP requirements and quality systems.

Luba Skibo M.S., an analytical chemist with 20 years of experience in the pharmaceutical industry, has worked at Pfizer and most recently served as the director of regulatory affairs for Merial Ltd. Pharmaceuticals managing global regulatory strategy and the post-approval management team for pharmaceutical and biological products.

“The complexity of pharmaceutical production and regulations demands experienced trainers and consultants who can offer expert guidance to companies and high quality education courses,” said Bob Pietrowski, Ph.D., managing partner of NSF-DBA. “We are pleased to welcome these individuals to the NSF-DBA team as together they bring over 140 years of combined expertise.”
Orasi, Biogen Enter Biomarker Technology Pact

Posted on April 12, 2011 @ 09:00 am

Orasi Medical has entered into an agreement with Biogen Idec to test novel biomarkers for the development of treatments for central nervous system (CNS) disorders. The companies will use Orasi’s technology to identify and test biomarkers based on magnetoencephalography (MEG) to assess the integrity of brain communication networks in real time and measure brain function in patients.

"We are quite pleased to partner with Biogen Idec on this innovative project," said Sarah Haecker, Ph.D. vice president, business development at Orasi Medical, "MEG-based biomarkers, will provide companies such as Biogen Idec with instruments to objectively measure drug effect and cost effective tools that better correlate with CNS disease states." Orasi Medical develops clinical neurophysiology biomarkers based on electrical activity of the brain and its products are being developed to help diagnose and track a variety of CNS diseases.

"There is a critical need for better tools to measure the effect of CNS therapeutics at all stages of clinical development," said Ajay Verma, M.D., Ph.D. vice president Translational Neurology, at Biogen Idec. "Through the use of Orasi Index and other Orasi MEG analytical approaches we will be able to gain critical insight into the treatment effects and mechanisms of CNS compounds in our pipeline."
Roche, Lonza Enter Assay Distribution Pact

Posted on April 11, 2011 @ 09:15 am

Roche and Lonza have entered into a distribution agreement for the commercialization of Roche’s MycoTOOL mycoplasma PCR assays. MycoTOOL detection kits are now available through Lonza for final release testing of pharmaceutical products, upon validation. Lonza also offers contract testing services using the MycoTOOL test, which is a commercial NAT-based detection system for mycoplasma biosafety testing of approved biologics.

Robert Yates, head of Roche Applied Science, said, “Lonza’s reputation for quality and customer care gives us confidence that MycoTOOL will be placed in the right applications for customers who wish to perform rapid mycoplasma testing in-house, and for those who prefer to send their samples to a qualified outside laboratory for testing.”

“Roche and Lonza share the rare combination of being both consumers and providers of pharmaceutical quality control and diagnostics products. This internal integration of user and manufacturer helps ensure products align properly with user requirements and capabilities. The unique perspective of being a user of the very products you sell provides insight unattainable from the outside looking in. We are pleased to be working with Roche in bringing this advancement to our colleagues,” said Lukas Utiger, head of Lonza BioSciences.

Executive Moves: Astellas Pharma Europe

Posted on April 11, 2011 @ 09:12 am

Ken Jones has been appointed president and chief executive officer of Astellas Pharma Europe Ltd. (APEL), the European subsidiary Astellas Pharma, Inc. Mr. Jones previously served as chief operating officer of APEL, since July 2007. He succeeds Masao Yoshida, who has been appointed president and chief executive officer of Astellas Pharma US, Inc., the U.S. subsidiary of Astellas Pharma Inc.

Mr. Jones, commented: "I am delighted and honored to be taking on this new role and I look forward to building on Astellas Pharma Europe's considerable achievements. In spite of the tough market conditions, we're in a strong position and have clear strategies for growth through expanding and developing our core franchises. Having the stability of a large company combined with the agility of a smaller operation gives us a real competitive advantage in terms of our ability to achieve these goals by responding rapidly to opportunities in the market. I hope to continue to drive solid growth for Astellas Pharma Europe in the years ahead."

Mr. Jones joined the company (then Yamanouchi) in January 2003 as vice president, European Marketing. In 2005, when Fujisawa and Yamanouchi merged to produce Astellas, he was promoted to senior vice president of sales, marketing and medical. Previously, Mr. Jones spent 16 years with Allergan, Inc., holding senior international marketing positions across the U.S., Europe and Japan.
Merck, Sun Pharma Establish Generics JV

Posted on April 11, 2011 @ 09:10 am

Merck & Co. and Sun Pharmaceutical Industries have created a joint venture to develop, manufacture and commercialize new combinations and formulations of branded generics in emerging markets. The partnership combines Sun Pharma's product development expertise using Sun Pharma Advanced Research Company (SPARC) platform technologies, and manufacturing network, with Merck's clinical development and registration expertise, and geographic commercial footprint. Financial details were not disclosed.

"Merck's Emerging Markets strategy is driven by our overarching focus on applying innovation across our business from introducing novel compounds to broadening our focus on innovative branded generics," said Kevin Ali, president, Emerging Markets, Merck/MSD. "By combining forces with Sun Pharma, we are complementing our innovative product portfolio with a solid foundation for addressing the diverse needs of patients, physicians and governments across the Emerging Markets."

“This joint venture reinforces our strategy of partnering to launch products using our highly innovative delivery technologies around the world," said Dilip S. Shanghvi, chairman and managing director, Sun Pharma. "Merck has an unrivalled reputation as a world leading, innovative, research-driven pharmaceutical company. We’re proud to be associated with them and look forward to working together."

Biogen MS Drug Shows Promise

Posted on April 11, 2011 @ 09:06 am

Biogen Idec achieved positive results from DEFINE, a Phase III trial evaluating the investigational oral compound BG-12 (dimethyl fumarate) as a monotherapy in people with relapsing-remitting multiple sclerosis (RRMS). Results showed that 240 mg of BG-12, administered either twice or three times a day, met the primary study endpoint, demonstrating a statistically significant reduction in patients with RRMS who relapsed at two years compared with placebo. Both doses of BG-12 also met all of the secondary study endpoints, providing a statistically significant reduction in annualized relapse rate, in the number of new or newly enlarging T2 hyperintense lesions, new gadolinium-enhancing (Gd+) lesions, and in the rate of disability progression at two years.

DEFINE, the first of two Phase III trials, was a global, randomized, double-blind, placebo-controlled, dose-comparison study to determine the efficacy and safety of BG-12 in people with RRMS. The trial also showed that BG-12 demonstrated a favorable safety and tolerability profile. BG-12 received Fast Track designation from the FDA in 2008.

“The significant clinical responses seen in the DEFINE study represent an important step forward in the development of BG-12 for multiple sclerosis (MS),” said Douglas Williams, Ph.D., Biogen Idec’s executive vice president of R&D. “We are very pleased with these data and believe that BG-12 has the potential to offer MS patients a highly effective oral treatment option with a strong safety profile.”
Invega Approved for Schizophrenia in Adolescents

Posted on April 11, 2011 @ 09:03 am

Johnson & Johnson received approval from the FDA for Invega (paliperidone) extended-release tablets for the treatment of schizophrenia in adolescents 12 to 17 years of age. The efficacy of Invega in adolescents was established in a six–week randomized, double-blind, placebo-controlled study using a fixed-dose weight-based treatment group design over a dose range of 1.5 to 12 milligrams per day. The Janssen Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., markets Invega in the U.S.

"Although rare, schizophrenia in adolescents is a very serious and disabling brain condition that affects every aspect of an adolescent's life and has significant consequences," said Husseini Manji, M.D., F.R.C.P.C., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. "This new indication for INVEGA® provides an additional option for clinicians who treat adolescents with schizophrenia and further demonstrates our commitment to helping people with diseases of the brain."
Eisai Expands into Brazil

Posted on April 8, 2011 @ 09:20 am

Eisai Inc. has established a subsidiary in Brazil called Eisai Participações Ltda. (Eisai Brazil), which will be based in Sao Paulo. Eisai Brazil’s focus will be on establishing an initial infrastructure to support its operations into the Brazilian market. The company’s areas of commercial focus will include neurology, oncology and critical care.

“The establishment of Eisai Brazil marks our entry into Latin America,” said Hajime Shimizu, president, New Markets and ASEAN, Eisai Co., Ltd. “In keeping with Eisai’s human health care mission to satisfy unmet medical needs and contribute to the health and well-being of people worldwide, this expansion will enable us to introduce many of Eisai’s first-in-class products to people living in Brazil.”
Amgen Buys Brazilian Pharma

Posted on April 8, 2011 @ 09:20 am

Amgen has expanded its operations into Brazil with the acquisition of Bergamo, a privately held Brazilian pharmaceutical company, for approximately $215 million. Amgen will also reacquire rights in Brazil to its products that were previously granted to Mantecorp (now Hypermarcas).

Bergamo supplies medicines to hospitals in Brazil and has capabilities in oncology medicines as well as manufacturing facilities in Sao Paulo. Bergamo had revenues of $80 million in 2010.

Under the agreement with Hypermarcas, Amgen reacquires the rights to several products, two of which are approved in Brazil, Vectibix (panitumumab) and Mimpara (cinacalcet), and a third, romiplostim, (registered as Nplate in the U.S.), a treatment for the blood disorder ITP, which is currently under review by ANVISA, the regulatory authority in Brazil.

“Amgen’s strategic goal is to make our innovative medicines available to patients in major markets around the world,” said Kevin Sharer, Amgen’s chairman and chief executive officer. “Acquiring Bergamo, a profitable company with an established local infrastructure, and regaining the rights to our products in Brazil, provides us an attractive entry into the Brazilian market.”
Impax, Banner Pharmacaps Enter Softgel Supply Pact

Posted on April 8, 2011 @ 09:19 am

Impax Laboratories has entered into a collaboration with Banner Pharmacaps to supply and commercialize two undisclosed softgel capsule products.

Larry Hsu, Ph.D., president and chief executive officer of Impax Laboratories, said, “We are excited to collaborate with Banner, a global leader in developing and manufacturing softgel products. In less than a year, we have entered into four distinct partnerships for alternate dosage form products as we continue to execute our strategy of diversifying our product base. Our business development activities will continue to focus on delivering growth from high-value products, technologies, and businesses in complementary dosage forms.”

Roger E. Gordon, Ph.D., president and chief executive officer of Banner Pharmacaps Inc., added, “We are delighted to be joining forces with Impax, a specialty pharmaceutical company whose vision and goals so closely mirror those of Banner. They join our expanding list of partners who look to Banner to provide expertise in the development of gelatin-based drug delivery systems and unique technology platforms.”

Aptar Pharma’s French Labs Registered with FDA

Posted on April 8, 2011 @ 09:17 am

Aptar Pharma’s French manufacturing sites in Le Vaudreuil and Val-de-Reuil have been registered as contract test labs for extractables testing with the FDA. Aptar Pharma can now provide pharma and biopharma companies working with its drug delivery devices with extractables testing for batch release of their drug products.

This is the second successful FDA inspection at Aptar’s sites at Le Vaudreuil and Val-de-Reuil, with no 483 inspectional observations made. The Aptar Pharma sites are ISO-15378 certified and operate under a cGMP-compliant quality system.
NextPharma Adds CTS Capabilities

Posted on April 8, 2011 @ 09:16 am

NextPharma has installed a ModuC LS IPC encapsulation/over-encapsulation filling machine at its Clinical Trials Services Center in Göttingen, Germany. The new machine is fully automated and capable of filling and over-encapsulating a range of solid and liquid products, with filling stations for powders, granules, pellets, tablets, capsules and micro-tablets. The filling stations can be operated individually or together for a range of filling possibilities. The company can now encapsulate and over-encapsulate as many as 20,000 units per hour.

Sean Marett, managing director, NextPharma Technologies, Product Development Services (PDS), said, “This new machine compliments our already extensive Clinical Trials Services capabilities in Göttingen. As clinical trials become more complex, we are pleased to be in a position to meet strong market demand for fast, efficient and accurate encapsulation and over-encapsulation of investigational medicinal products and their comparators for both large and small clinical trials.”
Pfizer, Zacharon in Rare Disease Pact

Posted on April 7, 2011 @ 09:20 am

Pfizer and Zacharon Pharmaceuticals have entered into a strategic research collaboration to develop drugs for orphan diseases, including lysosomal storage disorders. Zacharon will use its platform for developing small molecule drugs targeting specific carbohydrate polymers or glycans for the potential development of new compounds.

Zacharon will receive up-front payments and R&D funding and is eligible to receive development milestones, plus royalties and sales milestones upon commercialization. The potential value of the collaboration is approximately $210 million.

“We are very pleased to be working with Pfizer, which has broad compound development expertise, including in the area of small molecules, which should be quite useful to developing drugs for these orphan diseases,” said Robin Jackman, Ph.D., president and chief executive officer of Zacharon. “The collaboration provides validation for the potential that lies in Zacharon’s broadly applicable technology platform.”

Ed Mascioli, M.D., head of Pfizer’s Orphan & Genetic Diseases Unit, said, “Part of Pfizer’s Orphan & Genetic Diseases Unit’s strategic focus relies on collaborations with companies like Zacharon that have promising technologies to help develop treatments for rare diseases. Zacharon is an ideal partner, and we look forward to working with them to develop treatments for lysosomal storage diseases.”

AMRI, Parnell in Development and Supply Pact

Posted on April 7, 2011 @ 09:18 am

AMRI and Parnell Manufacturing Pty Ltd. have entered into a development and commercial supply agreement, under which AMRI will provide process development, manufacturing and supply of APIs to support Parnell’s New Animal Drug Application (NADA) with the FDA, as well as the commercial launch of the veterinary product in the U.S., pending approval. Development and manufacture of the API will take place at AMRI’s facilities in Albany, NY.

“We are pleased to support Parnell in its introduction of this important veterinary product to the U.S. market,” said AMRI chairman, president and chief executive officer Thomas E. D’Ambra, Ph.D. “Our new relationship with Parnell illustrates again AMRI’s ability to provide integrated support covering development and manufacturing to U.S. FDA standards. We look forward to working with Parnell to expeditiously achieve regulatory approval, a successful project launch and great success in the U.S. market.”

“Parnell sought expressions of interest for the development and long-term supply of this API from several companies and we are pleased that AMRI was ultimately successful in their tender. This product is an extremely important project for Parnell and the FDA compliant development is paramount to the successful launch,” said Parnell chief executive officer Robert Joseph.



GSK, XenoPort’s RLS Drug Gains FDA Approval

Posted on April 7, 2011 @ 09:17 am

GlaxoSmithKline and XenoPort, Inc. received approval from the FDA for Horizant (gabapentin enacarbil) Extended-Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). The approval is based on two 12-week trials in adults demonstrating the efficacy of Horizant in patients with moderate-to-severe primary RLS.

“Restless Legs Syndrome remains under-recognized, and many patients go untreated as a result,” said Atul Pande, M.D., senior vice president, GlaxoSmithKline Neurosciences Medicine Development Center. “GSK has been committed to helping patients and healthcare professionals better understand and treat this condition. We are pleased to provide a new treatment for moderate-to-severe primary Restless Legs Syndrome.”

“This significant milestone represents the culmination of XenoPort’s efforts to develop a non-dopaminergic therapy for patients with Restless Legs Syndrome,” said Ronald W. Barrett, Ph.D., XenoPort’s chief executive officer. “XenoPort is honored to have contributed to the efforts to find new treatments for Restless Legs Syndrome, and we hope that we can continue to develop other important medicines that can provide meaningful treatment benefit to sufferers of central nervous system disorders.”

OctoPlus Enters Formulation Pact

Posted on April 7, 2011 @ 09:16 am

OctoPlus N.V. has signed a feasibility agreement with a top-10 biopharmaceutical company to develop a controlled release formulation for an undisclosed peptide compound. Pending a successful evaluation, the contract may result in a full process development, manufacturing and licensing agreement. Financial terms were not disclosed.
Executive Moves: SCHOTT North America

Posted on April 7, 2011 @ 09:15 am

Linda S. Mayer has been appointed president and chief executive officer of SCHOTT North America, Inc. Ms. Mayer will head the 2,800-employee, North American operations of specialty glass and materials technologies. She succeeds Dr. Gerald Fine, who in January became a director of SCHOTT Corp. and a member of the company’s North American Advisory Board.

“We are very pleased to welcome Linda to SCHOTT,” said Prof. Dr. Ing. Udo Ungeheuer, chairman of the board of management of SCHOTT AG. “I am confident we have selected a proven leader. I would also like to thank Dr. Fine for his exemplary leadership and welcome him as a director.”

Ms. Mayer most recently served as a vice president and general manager for the aerial work platform division of Terex Corp., where she had global product P&L responsibility. Prior to that, Ms. Mayer was vice president of corporate marketing at Rexnord Corp., a manufacturer of power transmission and industrial components. She has also served in a variety of roles including marketing, financial analysis and corporate planning and development for the Kohler Co.

Camargo Expands Into Research Triangle Park

Posted on April 6, 2011 @ 09:13 am

Camargo Pharmaceutical Services has opened a new office in Research Triangle Park (RTP), NC in order to provide additional service offerings, as well as streamline client services. Camargo is focused on global drug development through the 505(b)(2) process and provides services from discovery through each phase of clinical development.

“Opening a new office in The Research Triangle Park brings us the opportunity for growth in both our staff and services,” said Ken Phelps, president and chief executive officer of Camargo Pharmaceutical Services. “We continue to utilize our specialized regulatory expertise to increase service offerings, such as bio-better drug development – biologics that are enhanced over the reference products. Using our proven knowledge of how to improve small molecule drugs, we can provide unique regulatory and program management services for preclinical and clinical trials for biologic-based drugs.”
Aptiv Solutions Creates Adaptive Trials Center

Posted on April 6, 2011 @ 09:08 am

Aptiv Solutions has created an Adaptive Clinical Trials Innovation Center comprised of thought leaders and experts in adaptive trial design, methodology and implementation. The leaders of the Innovation Center include: Reinhard Eisebitt, executive vice president and head of Innovation Center, Judith Quinlan, senior vice president of Trial Design Implementation, Andrew Grieve, senior vice president of Clinical Research Methodology, Vladimir Dragalin, senior vice president of Software Development and Consultingm, and Gernot Wassmer, senior vice president and principle software architect of ADDPLAN.

Mr. Eisebitt has 25 years of experience in the CRO industry. He co-founded ClinResearch, a CRO that specializes in the planning, execution and reporting of adaptive clinical trials, and co-founded the software company ADDPLAN, which created the first commercial adaptive trials software.

Ms. Quinlan has experience in both the pharmaceutical and CRO industries having held various leadership positions at GlaxoSmithKline, where she managed adaptive designs within her business areas, and was also involved in multiple initiatives to promote adaptive designs across GSK. She joined Aptiv from Cytel, Inc., where she was vice president of Adaptive Clinical Trial Services.

Mr. Grieve has more than 30 years of experience in the pharmaceutical industry, where he promoted the use of Bayesian methods and was involved in the development and implementation of Bayesian adaptive designs. He recently joined the company from King’s College London, where he was Professor of Medical Statistics.

Mr. Dragalin is an adaptive designs expert with 25 years of experience in developing the methodology of adaptive designs, and has 12 years of pharmaceutical industry experience having held positions at GlaxoSmithKline, Wyeth, Pfizer. Prior to joining Aptiv he led the Quintiles Center for Statistics in Drug Development.

Mr. Wassmer co-founded the software company ADDPLAN, the first commercial software package for the design, simulation, and analysis of adaptive clinical trials. He has 20 years of experience in clinical trial consulting for academia and industry and is adjunct professor of Medical Statistics at University of Cologne.

The Innovation Center team is collaborating with pharmaceutical and biotech companies, as well as regulatory authorities, to provide consulting on best practices for the use of adaptive designs. This team will work with clients to assist with the trial design, simulation and execution, develop adaptive trials software tools, and work with project teams in clinical operations, data management and statistics groups.

“We are pleased to have attracted such talented experts who have both industry and CRO experience in the design, simulation and execution of adaptive trials,” said Patrick K. Donnelly, chairman and chief executive officer of Aptiv Solutions. “Aptiv Solutions is leading the industry in the use of adaptive clinical trials, which can build significant efficiency into the clinical development process, enabling sponsors to make the correct development decisions sooner and get the right products to market faster.”
Lupin, Salix Expand Rifaximin Pact

Posted on April 6, 2011 @ 09:07 am

Lupin Ltd. has granted Salix Pharmaceuticals, Ltd. exclusive worldwide rights (except for India) to use Lupin technology for all rifaximin products for human use. This agreement expands the companies’ collaboration dating back to September 2009. Under the expanded agreement Lupin will supply Salix with rifaximin API and certain finished rifaximin products.

Lupin will receive a $10 million up-front payment as well as potential U.S. regulatory milestones for products covered by Lupin patents or jointly held patents. Lupin is also eligible to receive royalties on sales. Additionally, Salix will pay Lupin minimum quarterly payments for product development and other activities.
Optimer, Cubist Enter Dificid Co-promotion Pact

Posted on April 6, 2011 @ 09:02 am

Optimer Pharmaceuticals, Inc. and Cubist Pharmaceuticals, Inc. have signed an exclusive two-year co-promotion agreement to market Dificid (fidaxomicin) in the U.S. Dificid is an antibiotic currently under review by the FDA for the treatment of Clostridium difficile infection (CDI), also known as Clostridium difficile-associated diarrhea (CDAD). The FDA is expected to complete its review by a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2011.

Optimer will be responsible for the manufacturing and distribution of Dificid in the U.S. and for recording product revenue. Optimer will also be responsible for obtaining FDA approval, and will retain ownership of the NDA. Cubist will receive $15 million per year during the two-year agreement, beginning with the first commercial sale. Cubist is also eligible to receive an additional $5 million in the first year after commercialization, and $12.5 million in the second year if sales targets are achieved. Cubist will also receive a portion of Optimer's profits from any sales above the specified annual sales targets.

"Cubist has a proven track record and well established relations with all stakeholders involved in the antibiotics space. We believe this collaboration will maximize the impact of and de-risk Dificid's U.S. commercial launch, assuming approval," said Pedro Lichtinger, president and chief executive officer of Optimer. “We also believe this collaboration with Cubist will allow us to accelerate formulary adoption, and expand our market reach and penetration.”

Cubist's president and chief executive officer Michael Bonney, said, "We believe that the strengths of Cubist's seasoned sales force, medical affairs team and our experience in the hospital will add tremendous value to Optimer's launch strategy and execution. We look forward to working with Optimer to introduce a much needed therapy for seriously ill patients suffering from CDAD."
Merck To Acquire Inspire

Posted on April 5, 2011 @ 09:58 am

Merck will acquire ophthalmic-focused Inspire Pharmaceuticals for approximately $430 million in cash. The transaction was unanimously approved by the boards of both companies and Inspire’s board recommended that the company's shareholders tender their shares pursuant to the tender offer.

"Merck continues to build upon its long-term commitment to improving therapeutic options for the treatment of eye diseases," said Beverly Lybrand, senior vice president and general manager, neuroscience and ophthalmology, Merck. "This acquisition combines the talented commercialization organization at Inspire with the excellent team already in place at Merck thereby strengthening our ophthalmology business and positioning us for future growth with an expanded portfolio. This deal helps address the needs of patients and customers in ophthalmology and creates value for both companies."

In March, 2011, Merck announced that the NDA for Saflutan (tafluprost), an investigational preservative-free prostaglandin analogue ophthalmic solution, had been accepted for standard review by the FDA.

“As one of the world’s leading healthcare companies, Merck is the ideal partner to enhance the long-term potential of Inspire’s portfolio of ophthalmic assets. We are delighted that Merck recognized the strength of an integrated platform leveraging the growing Azasite (azithromycin ophthalmic solution) 1% product opportunity and the strong relationships within the ophthalmic community cultivated by our high quality, specialty eye care sales force in the U.S.,” said Adrian Adams, president and chief executive officer of Inspire. “Based upon an extensive analysis of various strategic options, as I have outlined since we announced the results of the TIGER-2 Phase 3 clinical trial, we believe this combination provides a compelling and timely opportunity for our shareholders to realize the value of their investment in Inspire.”
EAG Acquires Chemir

Posted on April 5, 2011 @ 09:20 am

Evans Analytical Group, Inc. (EAG) has acquired Chemir Analytical Services and its affiliates CAS-MI Laboratories and Cyanta Analytical Services. Chemir and CAS-MI will continue to operate under their current names, and Cyanta will be renamed EAG Life Sciences. All three labs will continue operations at their current facilities. Financial terms were not disclosed.

Chemir, based in St. Louis, MO, expands EAG’s service offering for medical device and pharmaceutical companies that require FDA testing beyond materials characterization and clients seeking to develop coating technologies beyond surface analysis investigations. Chemir also gives EAG’s clients greater access to analytical capabilities to determine the source of product failures or help defend a patent infringement case.

Cyanta Analytical Services, also of St. Louis, MO, specializes in cGMP and GLP analytical services such as stability programs, extractables and leachables, bioanalysis and custom synthesis to support pharmaceutical and medical device development. CAS-MI Laboratories of Ypsilanti, MI, provides analytical services for the polymer, paints, coatings, adhesives and sealants industries.

Harry Davoody, chief executive officer of EAG said, “With this acquisition we are excited that EAG can deliver our elite services to customers across a broader range of analytical, test and development offerings. The combination of our companies and integrated scope of services means EAG is a stronger partner for our clients, enabling them to more effectively achieve their time to market or solutions goals.”

David W. Riggs, president of Chemir, said, “Chemir is pleased to become part of an organization as solid as EAG. Over the past year and a half we have experienced our share of hurdles and with EAG as our new owner we have the financial resources and stability our clients deserve. We also feel Chemir’s long-term growth will benefit tremendously from EAG’s global reach and experience with international clients.”

Executive Moves: AMRI

Posted on April 5, 2011 @ 09:18 am

Peter J. Hansbury, RPh has been appointed vice president of aseptic services at AMRI. Mr. Hansbury assumes leadership for the company’s aseptic fill and finish facility in Burlington, MA and reports to Dr. Steven Hagen, vice president of pharmaceutical development and manufacturing.

Mr. Hansbury has more than 30 years of technical, sales and leadership experience in sterile products for the pharmaceutical, biopharmaceutical and healthcare industries. Most recently, he served as vice president and general manager of contract manufacturing services for Boehringer-Ingelheim - Ben Venue Laboratories, Inc., responsible for the overall management of Ben Venue’s contract manufacturing services division. Prior to that, he held several roles of increasing responsibility during his 15-year career at Ben Venue, including director of marketing and customer operations of the Bedford Laboratories division of BenVenue.

“We are pleased to welcome Mr. Hansbury to the AMRI leadership team,” said Mr. Hagen. “His expertise and experience in both the business of manufacturing and marketing specialty injectibles and sterile products make him an excellent choice for this business realizing an upswing in productivity and sales activity.”


Click here to learn more about AMRI
Executive Moves: Tegrant Corporation

Posted on April 5, 2011 @ 09:17 am

Kevin Longe has been appointed president of Tegrant Corp.’s ThermoSafe Brands business unit. “It is with great pleasure that I announce Kevin Longe as the new president of ThermoSafe Brands,” said Ron Leach, president and chief executive officer, Tegrant Corp. “His diverse background and broad commercial experience will be a tremendous asset in driving ThermoSafe Brands’ overall strategic growth plans in the U.S. and abroad.”

Mr. Longe has a diverse background and a proven track record implementing and executing strategies to build strategic partnerships with customers and produce long-term sales growth. Prior to joining Tegrant, he was president of Lydall Performance Materials Inc., responsible for four manufacturing and R&D locations in the U.S., St. Rivalain, France, and Maastricht, Netherlands. Previously, he held leadership positions at Electro Scientific Industries, Evapco, Inc., and Imeco, Inc.
Aegis, CTC Lab Systems In Software Solutions Pact

Posted on April 5, 2011 @ 09:14 am

Aegis Analytical Corp. has partnered with CTC Laboratory Systems Corp. (CTCLS), a solutions provider in Japan, to help sell Aegis' Discoverant software and oversee product implementations and customer support in Japan.

Together with Aegis' process development and manufacturing solution and CTCLS solutions, such as lab information management software, gene analysis software, adverse event reporting and clinical trial management software, the companies’ goal is to add value by reducing business and patient risk through the identification and control of process variability within manufacturing.

"CTCLS is the best partner to help Aegis with our expansion into the Asia Pacific region, and to support local Japanese customers, as well as worldwide customers that have manufacturing facilities in Japan," said Robert Di Scipio, Aegis president and chief executive officer.

"We look forward to sharing Aegis' expertise and solutions in Quality by Design (QbD), Process Analytical Technology (PAT) and manufacturing process understanding with life sciences manufacturers in the Japanese market," said CTCLS president and chief executive officer Hideki Negishi.



Morphotek Acquires TMI Tumor Targeting Assets

Posted on April 5, 2011 @ 09:11 am

Morphotek, Inc., a subsidiary of Eisai Inc., has acquired certain assets to a tumor-targeting platform from TransMolecular, Inc. (TMI) for an undisclosed upfront payment and development milestones. The tumor-targeting peptide (TTP) platform delivers conjugated radionucleotides, chemotoxins, nanoparticles and optical dyes to tumor cells via systemic administration. The TTP technology has been validated in multiple preclinical and clinical trials demonstrating tumor-specific delivery of conjugated TTP.

"While we are enthusiastic about the current technologies being utilized throughout our Eisai Product Creation Systems (EPCS) network to support our near-term pipeline goals, our strategy is to continue to pursue access to new cutting-edge technologies that will enable us to further support our current and future pipeline objectives to develop highly innovative medicines to address the needs of patients with serious illnesses, said Mr. Hideki Hayashi, chief product creation officer of Eisai Co., Ltd.“The acquisition of the TMI tumor targeting platform is yet another step in our evolution to become a leader in developing disease-specific compounds that can target disease cells and/or treat the underlying cause of a targeted disease."

Morphotek and Eisai will have exclusive ownership of TTP for therapeutic and diagnostic uses. Morphotek plans to pursue the TTP platform through collaboration with other EPCS units to develop TTP conjugates to treat a variety of cancers.

Pfizer To Sell Capsugel Unit for $2.4B

Posted on April 4, 2011 @ 09:56 am

Pfizer has entered an agreement with private equity firm KKR & Co. to sell its Capsugel unit for approximately $2.4 billion. The sale is expected to close in 3Q11.

Capsugel’s business includes hard gelatin capsules, liquid, softgel, non-animal and fish gelatin capsules, for use in pharmaceutical products and dietary supplements. The unit had approximately $750 million in revenue last year and manufactured more than 180 billion hard capsules. Capsugel’s global headquarters will remain in NJ.

In October of last year Pfizer announced plans to make additional share repurchases this year beyond its previous plans for $5 billion in buybacks for 2011. Pfizer also faces the loss of exclusivity for its top-selling drug Lipitor later this year.

For 2011, Pfizer projects a revenue drop of approximately $800 million as a result of the sales, with total revenues falling to a range of $65.2 billion to $67.2 billion, from $66 billion to $68.0 billion previously. It expects 2012 revenue of $62.2 billion to $64.7 billion, down from $63.0 billion to $65.5 billion previously.
Executive Moves: Daiichi Sankyo, Inc.

Posted on April 4, 2011 @ 09:55 am

John P. Gargiulo has been appointed president and chief executive officer of Daiichi Sankyo, Inc. (DSI), the U.S. division of Daiichi Sankyo Co. Ltd. Mr. Gargiulo succeeds Joseph P. Pieroni, who is retiring after leading Daiichi’s U.S. commercial operations for the past 14 years.

“John’s experiences within the pharmaceutical industry for the past 25 years have prepared him well for his new role and responsibility,” said Mr. Pieroni. “He has been instrumental in building and shaping the company since its inception in 1996, and has touched nearly every aspect of our business operations. His broad industry experience enabled him to learn and grow the commercial operations organization.”

Mr. Gargiulo most recently served as senior vice president of commercial operations, where he oversaw U.S. marketing, supply chain, managed markets and new product planning. Mr. Gargiulo was instrumental in advancing DSI from a joint venture with Parke-Davis to its current status as a leader in hypertension therapy, with an emerging presence in thrombosis and oncology.
MedImmune, Inserm Enter Research Pact

Posted on April 4, 2011 @ 09:52 am

MedImmune, AstraZeneca’s biologics business, and Inserm Transfert have entered a three-year strategic research collaboration for a range of therapeutic areas including oncology, respiratory, inflammation, and autoimmune diseases. The research will explore translational biology and new disease mechanisms, as well as evaluate potential drug candidates. Financial details were not disclosed.

MedImmune will fund the scientific collaboration that will initially investigate 10 research projects, leveraging Inserm’s capability to conduct research by blended physician/biologist teams, and their link to patient populations and understanding of human diseases. Inserm, the private subsidiary of the French National Institute of the Health and Medical Research, has operations in 316 laboratories, with 54 clinical investigation centers representing a workforce of 13,000. MedImmune will fund projects for both preclinical and clinical research, and will perform other activities to help identify promising approaches to advance drug candidates.

“MedImmune is honored and energized to have this unique opportunity to partner with an organization the caliber of Inserm on discovery and development,” said Bahija Jallal, Ph.D., MedImmune’s executive vice president of R&D. “This new relationship exemplifies our externalization strategy to invest in the best science, academic expertise, and innovation while enhancing productivity and quality of discovery research outcomes.”

“Knowledge transfer today is about connecting excellence in academia and industry and building partnered teams to promote innovation,” said Cécile Tharaud, chief executive officer of Inserm Transfert. “MedImmune is a partner of choice and we are highly committed to building this strategic alliance with the potential to turn ‘open innovation’ concepts into novel therapeutic products to benefit patients.”
Avanir Files IND for Pain Drug in MS

Posted on April 4, 2011 @ 09:50 am

Avanir Pharmaceuticals, Inc. has filed an IND application with the FDA to begin a large Phase II trial of AVP-923, an investigational drug for the treatment of central neuropathic pain in patients with multiple sclerosis (MS).

The study will evaluate the safety, tolerability, and efficacy of three dose levels of AVP-923 capsules for the treatment of central neuropathic pain in MS patients. AVP-923 is a combination of dextromethorphan (DM) and quinidine (Q). The trial is a multicenter, randomized, double-blind, placebo-controlled, four-arm parallel group study. The primary efficacy endpoint is the Pain Rating Scale obtained from daily patient diaries. Secondary endpoints include measures of fatigue, disability, impact of MS on daily life, sleep quality, cognition and depression.

“Over half of MS patients suffer from chronic and debilitating pain, with a substantial negative impact on their quality of life. With no FDA-approved therapies to treat central neuropathic pain in MS patients, this represents an area of high unmet medical need,” said Randall Kaye, M.D., chief medical officer of Avanir Pharmaceuticals. “The team at Avanir has done an exemplary job of designing and developing a program to explore the potential of AVP-923 in MS-related pain as well as other important endpoints including fatigue, sleep quality and cognition. We are excited about the potential of this compound, which may ultimately represent a new approach to treating central neuropathic pain in MS patients.”
Invida To Handle Roche PC Portfolio in Korea

Posted on April 1, 2011 @ 10:08 am

Invida Group Pte Ltd. has entered into a partnership agreement with Roche for the commercialization and marketing of Roche’s primary care portfolio throughout Korea. Invida’s commercialization of these products and will allow Roche to focus on its specialty care portfolio in Korea.

Invida will manage all of the marketing and sales activities for Roche’s primary care products, including Xenical and Roaccutane, as well as products from Roche’s CNS portfolio, including Madopar for the treatment of Parkinson’s disease and Rivotril for epilepsy and Valium. Roche Korea has restructured for 2011 as part of its recently announced Operational Excellence Program.

Mark Brown, general manager, Invida Korea, commented, “We are excited to partner with Roche and provide them with the vital infrastructure to promote these products in the Korean market. In developing our agreement with Roche, we were very conscious of creating an alliance structure that would work within the Korean market and provide outstanding products for patients, while benefiting both companies. Roche’s primary care portfolio is one that will benefit greatly from the additional promotion that Invida will invest in it, and allow Roche to focus on developing other core areas of business.”

Svend Petersen, general manager, Roche Korea, said, “Our partnership with Invida is critical to ensure our success in further penetrating the Korean market. In working with Invida and utilizing their strong infrastructure and proven sales and marketing methodologies, we will be able to gain rapid market access for these products and reach primary care physicians throughout the region. This alliance will support our business goals by allowing us to shift resources and focus on our specialty care portfolio. We plan to continue to bring innovative products into Korea that will meet the needs of Korean patients.”
Fujifilm Launches Fujifilm Diosynth Biotechnologies

Posted on April 1, 2011 @ 10:03 am

The former Merck BioManufacturing Network has been named Fujifilm Diosynth Biotechnologies following the completion of FUJIFILM Corp.’s recent acquisition of the company. The acquisition includes the facilities located in Billingham, UK (MSD Biologics Ltd., formerly Avecia Biologics) and Research Triangle Park, NC (Diosynth RTP LLC).

Yuzo Toda, general manager of Pharmaceutical Products Division, FUJIFILM Corp., said, “We are delighted to complete the addition of this business to Fujifilm’s growing portfolio of healthcare and life science businesses. We intend that Fujifilm Diosynth Biotechnologies will lead the global Biologics CMO industry through continuous innovation of technologies, service delivery and quality, contributing to the enhancement of the quality of life of people worldwide. Key to this is the very talented and experienced workforce at both Billingham and RTP, backed by world-leading technologies and first-class manufacturing assets.”

Steve Bagshaw, managing director, Fujifilm Diosynth Biotechnologies, Billingham UK, added, “This transition of ownership to Fujifilm, and closer collaboration with our U.S. colleagues in NC will truly position us as a world leading contract biologics development and manufacturing business. We look forward to working with both existing and new customers to help bring their drug developments to market.”
Executive Moves: AAIPharma

Posted on April 1, 2011 @ 10:02 am

Dean Shirazi, Ph.D., has been appointed vice president of Analytical Development at AAIPharma Services Corp. Dr. Shirazi joined the company in June 1992 as a senior scientist and has served in a variety of key positions, including director of method development, divisional director, and, most recently, senior director of the Analytical Group. He has expertise in the field of chromatography.

“Dean is a key member of our Analytical team,” said George Spanos, Ph.D., vice president, Laboratory Services. “He is an outstanding scientist who is recognized in the method development and method validation business, and is also a respected mentor to young scientists here.”
PPD Joins PDP Consortium

Posted on April 1, 2011 @ 10:01 am

PPD, Inc. has been selected as a preferred provider to a consortium of 14 global health Product Development Partners (PDPs) to develop medicines for some of the world’s poorest countries. PPD will provide discovery, clinical development and post-approval services for drug and vaccine development for health initiatives for infectious diseases like HIV, tuberculosis and malaria and neglected diseases such as visceral leishmaniasis, Chagas disease and Human African trypanosomiasis.

“PPD is committed to enhancing health care worldwide by delivering the safest, most reliable drug discovery and development services,” said David Grange, chief executive officer of PPD. “Our company has a long history of supporting global government and public health initiatives, and we are pleased to share our clinical research capabilities with consortium members to help get safe, effective medicines to those who need them.”

Megan Paye, vice president of government and public health services for PPD, added, “This initiative aligns with PPD’s extensive experience in neglected tropical diseases and supports our mission of expanding work with nonprofit organizations to improve global health. Having worked in infrastructure-constrained settings, PPD will bring unique site evaluation, capacity planning/site management, physician relationships, and multinational global regulatory and quality strategies to benefit the PDPs in advancing their drug development programs.”
Pillar5 Pharma Passes Canadian GMP Inspection

Posted on April 1, 2011 @ 10:00 am

Pillar5 Pharma, Inc. recently underwent a successful GMP inspection by Health Canada. The inspection covered solid dose and aseptic manufacturing, and all quality systems. Pillar5 Pharma was issued a compliant rating by Health Canada’s Health Products and Food Branch.

“Receiving another compliant rating from Health Canada is a testament to the high level of attention paid to our quality processes and to the experience and technical knowledge of our employees,” said president and chief executive officer John Carkner.

March 2011

Merck Serono, Newron Broaden CNS Pact

Posted on March 31, 2011 @ 05:49 am

Merck Serono, a division of Merck KGaA, has entered into an agreement that broadens the scope of the collaboration with Newron Pharmaceuticals S.p.A. The two companies are already collaborating on the development of safinamide in Parkinson’s disease.

Newron will receive a development license for two Merck clinical-stage compounds, pruvanserin and sarizotan. Merck will retain buy-back options for each compound upon completion of proof-of-concept trials. Should these options be exercised by Merck, Newron will have a co-development option. Financial terms were not disclosed.

Pruvanserin and sarizotan are highly selective compounds for specific serotonin or dopamine receptors and modulate the activity of these neurotransmitters in the brain. Both compounds exhibit pharmacological properties and have clinical data that support further evaluation and development. Newron will assess the potential of these compounds in additional preclinical experiments prior to initiating proof-of-concept studies in central nervous system (CNS) diseases.

“We are very pleased to continue building our relationship with Newron,” said Dr. Bernhard Kirschbaum, executive vice president for Global R&D at Merck Serono. “We believe that this expanded collaboration will leverage Newron’s strong expertise in the early-stage development of compounds targeting CNS indications.”
AAIPharma Relocates, Expands Compendial Testing

Posted on March 31, 2011 @ 05:44 am

AAIPharma Services Corp. has relocated its compendial raw materials testing group to a new purpose-built laboratory space located within the company's Wilmington, NC headquarters. The move follows a series of recent reinvestments into the company's core analytical testing business.

The new lab will tie together the compendial raw material testing lab and its supporting business group under one roof. The new location will increase turnaround times for high-quality raw materials testing. The company states that a standard 10-day turnaround will be offered for most compendial raw materials.

Features of the new GMP laboratory space include state-of-the-art engineering controls, updated IT infrastructure utilizing Waters Empower-2 Chromatography Network data acquisition software, updated gas generation systems to support the dedicated Agilent 6890 gas chromatographs, HPLC systems for improved sample through-put and "completely updated support systems down to the new Milli-Q water systems and Lancer Laboratory Glassware Washer." In addition, the move integrates AAIPharma Services' physical chemistry and raw materials Laboratories to provide full service compendial testing and API characterization in-house.

Group manager Ryan Taro remarked, "This investment is one more sign of the commitment AAIPharma Services has to its customers in providing top-notch, cGMP testing services to support pharmaceutical and biotech industries." Future planned improvements include implementation of an online quotation and sample submission system that will facilitate how clients request quotes and submit samples for testing.

The recent lab move is a physical relocation of current lab operations, not a "laboratory site change" associated with the transfer of lab operations from one company to another.
Isogenica Opens North American Office

Posted on March 30, 2011 @ 05:49 am

Isogenica has established a dedicated business development and customer support team based in Alameda, CA. The team will provide direct support to existing and prospective customers in the U.S. and Canada. According to a company statement, "This latest development ensures Isogenica is now well positioned to address the antibody, protein and peptide engineering needs of its rapidly growing user base across North America."

The company also announced the appointment of Garry Merry as Business Development Consultant for North America. Before joining Isogenica, Mr. Merry was with Sloning Biotechnologies, where he was instrumental in establishing its gene library technology for antibody development and protein engineering. He has also held senior executive positions with other successful life science companies, such as Applied Biosystems, Millipore and Qiagen.

Dr Kevin Matthews, Isogenica's chief executive officer, remarked, “The creation of our new North American office is a critical milestone in the maturation of the company. Isogenica has already experienced significant success in 2011, with Johnson & Johnson Pharmaceutical Research Division. For established as well as prospective clients we understand that direct personal contact is fundamental to the proposition as well as essential for us to achieve our overall growth potential as a company. I am delighted that Garry will be underpinning our efforts in North America. He has an excellent knowledge of the market, and has established relationships with most of the key players in the field of antibody engineering, I look forward to his contribution”.
Dainippon Sumitomo, Intercept in Liver Drug Pact

Posted on March 30, 2011 @ 05:44 am

Dainippon Sumitomo Pharma Co, Ltd. (DSP) and Intercept Pharmaceuticals have entered into an exclusive licensing agreement for the development and commercialization of Intercept's first-in-class FXR agonist obeticholic acid (OCA, also known as INT-747). DSP will advance OCA in Japan and China for the treatment of chronic liver diseases, with an initial focus on primary biliary cirrhosis (PBC) and nonalcoholic steatohepatitis (NASH). Intercept is currently preparing for the initiation of a Phase III PBC program in the U.S. and Europe and, under the company's cooperative research and development agreement (CRADA) with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), a large placebo-controlled trial of OCA in NASH patients recently started enrolling in the U.S.

Intercept will receive an initial payment from DSP of $15 million and will be eligible to receive approximately $300 million in additional milestone payments associated with the successful development and commercialization of OCA. Upon launch of OCA, Intercept will be entitled to receive tiered double-digit royalties from DSP based on sales in its territory. DSP has the exclusive option to add several other Asian countries to its territory, including Korea and Taiwan, and to pursue additional indications. DSP will be responsible for the costs of developing and commercializing OCA in its territory.

"OCA is an important strategic addition to our growing pipeline of hepatology drugs and reflects DSP's strong commitment to specialty therapeutic areas," said Masayo Tada, president and chief executive officer of DSP. "There is a very high unmet medical need in the hepatology area in Asia and DSP's marketed products Sumiferon, a natural alpha interferon, and Miripla, a therapeutic agent for hepatocellular carcinoma, benefit many thousands of liver patients in Japan. We strongly believe that OCA has the potential to significantly add to the treatment options DSP can make available to these patients and are looking forward to working with Intercept to bring OCA to the market as an important new therapy for PBC and the first drug approved for NASH."
Executive Moves: BioStorage Technologies

Posted on March 29, 2011 @ 08:00 am

Piet Smet has been appointed director of business development for BioStorage Technologies’ European operations. Smet joins the company with more than 20 years of experience in clinical research sales and operational management. In his new role, Smet will be responsible for leading the European sales team and overseeing the development of new and existing customer relationships.

Prior to joining the company, Smet founded and managed PS consulting, a firm providing long-term and project-based management support for the life sciences industry. Smet has also held management positions with BARC Central Laboratory and MSOURCE, an international CRO.

“Piet’s experience will be critical in identifying key business opportunities as we continue to expand our Europe operations to provide the most comprehensive portfolio of services for complete sample asset management,” said Lori Ball, chief operating officer, BioStorage Technologies. “We are proud to welcome Piet to our team.”

Chiltern Opens Netherlands Office

Posted on March 29, 2011 @ 07:35 am

Chiltern International Ltd. has opened a new office in the Netherlands, appointing Angela Pasma as the Netherlands' Country Manager.

Mr. Maurizio Passanisi, Chiltern's director of the Benelux Region commented, "The Netherlands continues to be an excellent place for clinical research with experienced investigators as well as highly regarded international key opinion leaders, all adhering to the highest of medical standards."

He added, "Furthermore, in leading the growth of the Chiltern office in Leiden, Ms. Pasma brings a wealth of knowledge and experience to support Chiltern's growing full service clinical and flexible staffing services in the region."

Armand Czaplinski, executive director, Global Country Management for Chiltern, noted, "Chiltern's expansion in the Netherlands aligns perfectly with our primary goal to deliver expert, high quality services around the world and demonstrates our ongoing commitment to regional expansion in order to serve our clients' needs globally."
PPD Launches CTM App

Posted on March 29, 2011 @ 07:30 am

PPD, Inc. has launched its new Clinical Trials Mobile application for use on Apple iPad and Apple iPhone devices to help potential clinical research participants and investigators find clinical trials across a wide range of therapeutic areas.

According to a PPD statement, the app provides quick and advanced keyword search menus, allowing users to search the U.S. National Library of Medicine ClinicalTrials.gov database of more than 100,000 global clinical trials. Users can customize their search by location, gender, age and other search criteria. The application gives users details about specific trials such as eligibility criteria, trial locations and contact information. Trial searches can be saved for future reference and detailed trial information can be sent via email.

In addition, investigators and potential U.S.-based clinical trial participants can register in PPD's ClinicalTrials.com database to be alerted as new clinical trials become available that meet their specific criteria. The app is downloadable via Apple's iTunes store.

"Mobile devices have become important tools for potential patients and investigators in their search for clinical trials targeted toward a specific disease," said Mike Wilkinson, Ph.D., executive vice president and chief information officer for PPD. "PPD is focused on delivering new technologies that educate these groups about the opportunities available to them and making the search for finding clinical trials an easier, more efficient process."
ICON Opens Shanghai Office

Posted on March 29, 2011 @ 07:26 am

ICON plc has continued its expansion in the Asia-Pacific by opening a new office in Shanghai, China, and is also relocating its Beijing operations to larger premises. In addition, ICON has announced the appointment Dr. Malcolm Burgess to the position of executive vice president, Asia-Pacific, and Paula Mumby to vice president, Operations, Asia-Pacific for ICON’s resourcing business unit, DOCS.

Commenting on the announcement, Peter Gray, ICON's chief executive officer, said, “China is currently the third largest pharmaceutical market in the world and will soon become the second largest, as more and more pharmaceutical companies move their research to this region. We are growing our presence in this important market, as well as the broader Asia-Pacific region, and we have a highly experienced leadership team in place to support our plans for further growth.”

Dr. Burgess joined ICON in 2002 and has held a variety of leadership positions within the company, including chief operating officer, U.S. Operations from 2006 to 2009. He has more than 30 years’ experience within the pharmaceutical industry and prior to ICON worked with Novartis, Hoechst Marion Roussel and SmithKline Beecham.

Ms. Mumby has more than 18 years’ experience in the pharmaceutical, CRO, biotechnology and medical device industries in the UK and Asia Pacific and has more than 10 years’ resourcing experience. Prior to joining DOCS, Ms. Mumby was vice president, Asia Pacific and Japan at i3 Pharma Resourcing and also held a clinical development role at CSL.
Executive Moves: Roche

Posted on March 28, 2011 @ 09:30 am

Janet Hammond, M.D., Ph.D., has been appointed vice president of Translational Medicine – Virology in Pharmaceutical Research and Early Development (pRED) at Roche. Dr. Hammond will report to Jacques Banchereau, Ph.D., Discovery and Translational Area (DTA) head for Inflammation and Virology, and chief scientific officer at Nutley. She will be responsible for driving strategy and implementation of early clinical development for the Virology DTA.

Dr. Hammond has 13 years of experience in the pharmaceutical industry. Prior to joining the company, Dr. Hammond served as chief medical officer and senior vice president of Global Medical Affairs at Valeant Pharmaceuticals, where she was responsible for medical affairs and worldwide pharmacovigilence activities. As chair of the Global Safety Board, she was also responsible for ensuring patient, clinical trial and product safety. Other positions include serving as group director, Global Clinical Research, Virology and Infections Diseases at Bristol-Myers Squibb, and head of Clinical Drug Discovery Virology at GlaxoSmithKline.

“Janet’s background and experience will be a great addition to our efforts to drive Translational Medicine as well as Virology within Roche as we continue our quest to find new and more effective approaches to drug development, ultimately providing better options for patients,” said Dr. Banchereau.

Ecron Acunova Acquires aCROnordic

Posted on March 28, 2011 @ 09:28 am

Ecron Acunova has acquired aCROnordic, a full service CRO covering Denmark, Sweden, Finland and Norway, expanding Ecron’s clinical research presence in the region. Mr. Søren Strøh, founder and chief executive officer of aCROnordic, will continue in his role for the Nordic region.

Mr. D.A. Prasanna, founder and chairman of Ecron Acunova, said, “A recent change in the strategy of sponsors in the healthcare industry asks for more global presence of preferred provider CROs. The merger of EA and aCROnordic, both having decades of track record, an excellent reputation and deep local knowledge in their geographies, yields substantial synergy to both of us for serving our clients’ needs.”

“The merger has created great enthusiasm in aCROnordic. We see this as an opportunity to fulfill our dream of being the first Nordic development CRO in an international organization. The trust in this merger is the crowning consequence of our cooperation during the past 7 years. We have successfully delivered service on joint international projects with harmonized SOPs. As Nordic region’s leading CRO, we are happy to offer clients our well-known and personalized services on a larger geographic and therapeutic platform now,” said Mr. Strøh.
Executive Moves: AVI BioPharma

Posted on March 28, 2011 @ 09:27 am

Peter S. Linsley, Ph.D., has been appointed chief scientific officer of AVI BioPharma, Inc., effective May 1, 2011. Dr. Linsley is recognized industry-wide for his RNA- and microRNA-focused research as well as his work in advancing scientific discoveries into clinical development. He will be charged with continuing AVI’s strategy to create a world-class executive leadership team.

Prior to joining the company, Dr. Linsley was chief scientific officer of Regulus Therapeutics, a joint venture of Alnylam Pharmaceuticals and Isis Pharmaceuticals, created to focus on the discovery and development of drug candidates that target microRNAs. At Regulus, Dr. Linsley led the company’s R&D efforts and built a scientific base for some of the first strategic transactions in the microRNA therapeutic arena. Previously he was executive director of Cancer Biology at Merck Research Laboratories, where he led efforts to implement RNA interference technologies that culminated in Merck’s 2007 acquisition of Sirna Therapeutics, Inc.

“Peter’s rare combination of RNA-specific thought-leadership and drug discovery expertise positions him to play an integral role in establishing AVI’s PMO-based chemistry as a leading medical technology,” said Chris Garabedian, chief executive officer of AVI BioPharma. “We welcome Peter to our team as we look to expand and advance our pipeline of morpholino drug candidates to target a variety of disease areas.”
Cellceutix Signs CDA for Autism Drug

Posted on March 28, 2011 @ 09:26 am

Cellceutix Corp. has entered into a Confidential Disclosure Agreement (CDA) with a large pharmaceutical company for KM-391, its novel compound being developed as a treatment for autism.

Cellceutix chief executive officer, Leo Ehrlich, commented, “This is simply another vote of confidence from large pharma as to the strength of our pipeline and a testament to the attention that we are receiving on a global level. While signing a CDA does not imply or guarantee that a licensing deal or any other transaction will happen, it is important in the sense of industry recognition of our compounds, as the signing of a CDA this early in development is generally a very rare occurrence.”

Cellceutix’s formulation manufacturer, Formatech, has completed production of Kevetrin for use in trials. Kevetrin is a compound targeting lung, breast, colon and other cancers not responding to existing drug therapies. Cellceutix is on schedule to file its IND with the FDA in May 2011.
Quintiles Named Provider to PDP Consortium

Posted on March 25, 2011 @ 09:12 am

Quintiles has been named a preferred provider to 14 global health Product Development Partnerships (PDPs), a consortium that leverages their combined pipelines in an effort the get the most cost effective use of their R&D spend. PDPs are not-for-profit entities seeking to discover, develop and deliver new affordable medicines for some of the most neglected diseases in the world.

The 14 PDPs anticipate funding 128 Phase I-IV trials over the next two years. Quintiles will partner with the consortium to provide access to its global clinical development infrastructure, particularly in the area of infectious diseases such as HIV, malaria and tuberculosis.

“Quintiles is extremely pleased to have been chosen by the consortium members,” said Dr. Kelly McKee, Quintiles vice president and managing director, Public Health and Government Services. “The work they’re doing has the potential to reshape global health within a generation. The public health issues on which they are focused have the potential to save millions of lives. We are very excited to be named a preferred provider to the consortium and look forward to helping advance this critical mission.”
Executive Moves: Lexicon Pharmaceuticals

Posted on March 25, 2011 @ 09:11 am

Pablo Lapuerta, M.D., has been appointed chief medical officer at Lexicon Pharmaceuticals, Inc. Dr. Lapuerta will be responsible for directing clinical development of drug candidates from Phase II proof-of-concept through Phase III and approval.

Dr. Lapuerta has 15 years of pharmaceutical industry experience in a variety of leadership roles in drug development, global medical affairs and outcomes research strategy across multiple therapeutic areas. Most recently, he served as vice president at Bristol-Myers Squibb, where he was responsible for global development of an Alzheimer’s disease drug candidate associated with the use of an innovative biomarker.

“Dr. Lapuerta’s extensive experience in clinical development, regulatory strategy, and medical affairs are especially valuable as we progress the four programs we currently have in mid-stage clinical studies,” said Dr. Arthur T. Sands, president and chief executive officer of Lexicon. “His breadth of knowledge in multiple therapeutic areas meshes well with Lexicon’s broad pipeline in drug discovery and development.”
Executive Moves: ZS Associates

Posted on March 25, 2011 @ 09:10 am

Sanjay Joshi, Alex Contreras, Bill Sudlow and Ashish Vazirani will join ZS Associates leadership teams for the company’s global sales and marketing operations, business technology, software development and high-tech practice areas.

“These new leaders bring deep expertise and the ability to help our clients improve their commercial operations and accelerate business performance,” said managing director Jaideep Bajaj. “Their experience makes these individuals uniquely qualified to help ZS develop client services that focus on leading-edge business technology ideas, such as analytics process outsourcing, enterprise information management and business intelligence.”

Mr. Joshi is a 20-year veteran in management and business and technology outsourcing consulting. As a managing principal he will lead the growth of the company’s global operations practice. He is based out of the firm’s New York office. Mr. Joshi has experience across multiple industries, including healthcare, technology, telecom, consumer products and financial services.

Mr. Contreras has expertise in information technology strategy, architecture and business transformation. He will serve as principal and member of the leadership team in the firm’s business technology group based in Los Angeles.

Mr. Sudlow has 25 years of software product development and management experience. He will serve as chief technology officer and principal in charge of the company’s software development group based in the company’s global headquarters in Evanston, IL. Mr. Sudlow has extensive experience developing and delivering on-demand software-as-a-service (SaaS).

Mr. Vazirani, a 15-year sales and marketing management veteran, will serve as principal and leader of ZS Associates’ high-tech practice and will be based at the company’s San Mateo, CA office. Mr. Vazirani has led numerous large engagements with global technology and health care companies and has been the architect of major marketing and sales organization restructuring.
Genzyme’s Thyrogen Production Delayed

Posted on March 24, 2011 @ 09:27 am

Genzyme Corp. has encountered a manufacturing problem during the fill/finish stage of production of Thyrogen at its Allston, MA plant. As a result, a shortage of the thyroid medicine for Fabry’s disease is expected. The problem led to the rejection of a single lot of the drug because of a quality issue. Genzyme plans to fill and finish all future lots of Fabrazyme at a contract manufacturing facility operated by Hospira Inc., which already handles a large portion of Fabrazyme’s fill/finish.

Lori Gorski a spokeswoman for Genzyme stated that bulk drug production for both Fabrazyme and Cerezyme is proceeding successfully at the plant. One of the Contingent Value Rights in Sanofi’s acquisition of Genzyme is tied to a production quote of Fabrazyme.

According to the company, the rejected lot will cause some patients to delay treatment, while others may miss doses in coming months. Because of the shortages, the FDA has allowed Shire’s Fabry drug Replagal to be used under a special protocol, despite not being approved for marketing. Replagal is approved in Europe, and Shire has plans to file with the FDA.


Click here to learn more about Hospira
West, CareFusion to Develop Needle-Free Vial Device

Posted on March 24, 2011 @ 09:24 am

West Pharmaceutical Services and CareFusion will jointly develop and market a new, needle-free vial access device. This initiative is part of a five-year global distribution and supply agreement between the two companies.

The new product, which will be available in late 2011, will be designed to help prevent leaks, as well as reduce surface contamination and risk of exposure during a drug product’s reconstitution process. The system will be based on West’s vented vial adapter in combination with CareFusion’s needle-free connector and closed male luer technologies.

“West is pleased to offer its vented vial adapter technology with CareFusion to develop safer products for patients and caregivers. This new vented-vial access system can be used for transportation, reconstitution and administration of hazardous substances such as chemotherapy, antivirals and other cytotoxic drug products,” said Glen Zimmermann, associate director marketing, West Administration Systems, Americas. “We look forward to working with CareFusion on future development projects.”

“The safety of health care workers is one of our primary concerns,” said Bob Tolliver, director of OEM business development, Infusion for CareFusion. “This innovative component will be a strong addition to our existing portfolio designed to help protect clinicians from accidental exposure to hazardous drugs.”

The companies signed a development and distribution agreement in September 2010 providing West with exclusive worldwide rights to sell the Texium closed male luer to pharmaceutical companies and contract manufacturers as part of a drug kit. West also obtains non-exclusive rights to sell SmartSite in conjunction with Texium.
Sanofi Enters Diabetes Research Pact

Posted on March 24, 2011 @ 09:22 am

Sanofi-Aventis has entered into a research collaboration with Columbia University Medical Center for the development of new diabetes treatments. The three-year research collaboration with Dr. Gerard Karsenty’s lab will investigate the role of the osteoblast-secreted peptide, osteocalcin, in diabetes management. Sanofi will sponsor research in Dr. Karsenty’s lab and has an option to license and develop existing patents as well as any results from the research. Financial terms were not disclosed.

“We have spent more than a decade uncovering the biology of osteocalcin,” said Dr. Karsenty. “We are delighted to have Sanofi-aventis as a collaborating partner to help us continue this research.”
Beardsworth CRO Founder Dies

Posted on March 24, 2011 @ 09:20 am

Donna E. Beardsworth, the founder, president and chief executive officer of the CRO, Beardsworth Consulting Group, Inc., has died unexpectedly at age 54. The board has appointed Michael O’Brien as the president and chief executive officer. Mr. O’Brien, who has been with the company for nine years, previously served as president and CEO, until December 2010.

“We are shocked and greatly saddened by the passing of Donna. She was a dear friend who cared deeply about people and humanity. Donna was a visionary leader, a devoted clinician and a mentor to many within the Clinical Research Industry. The people with whom she worked over the years will deeply mourn her loss and miss her spirit. We extend our sympathies to her family and all of her friends,” said Vincent F. DiBianca, a principal in the company.

“Donna’s vision for our company was to focus on complicated clinical trials in oncology and other difficult therapeutic areas. Her goal was to make an impactful difference in healthcare. She was a true pioneer in the CRO industry, and we have all been inspired by her dedication and limitless spirit,” said Mr. O’Brien. “Donna was very proud to be ushering in the 25th anniversary of Beardsworth this year, and the company is fully committed to continuing her legacy.”

Ms. Beardsworth was honored with the Entrepreneur of the Year Award by the Hunterdon County Chamber of Commerce, in recognition of her corporate stewardship and vision.
Sinclair, Invida Expand Commercialization Pact

Posted on March 23, 2011 @ 09:24 am

Sinclair Pharma and Invida Holdings Pvt. Ltd. have expanded their collaboration to include India in their long-term partnership for the commercialization of Sinclair’s dermatology brands in the Asia-Pacific region. Invida is a specialty biopharmaceutical company with 4,000 employees and a presence in all major markets, including India. The expanded collaboration now includes 12 markets within the Asia Pacific region under which Invida has exclusivity for Sinclair’s dermatology and wound care brands.

The Sinclair-Invida partnership is preparing for the commercialization phase for the initial launches. In India, Invida’s resources will be focused primarily on commercializing Sinclair’s products for atopic dermatitis, seborrhoeic dermatitis and acne. Invida’s team in India will be supported by Sinclair’s locally based regional business director to help ensure the timelines and success of these launches.

Chris Spooner, chief executive officer of Sinclair, said, “As a leading emerging market with the potential for sustainable high growth, India is key for Sinclair and Invida has again proved the compelling partner of choice with its demonstrable ambition, presence and commitment to our portfolio.”

John Graham, chief executive officer of Invida, said, ”I am delighted to expand our regional collaboration with Sinclair in India. This addition demonstrates the high confidence Sinclair has in Invida’s market expertise in India and throughout the region.”
PRECOS, Argenta Extend Oncology Alliance

Posted on March 23, 2011 @ 09:23 am

Preclinical Oncology Services Ltd. (PRECOS) has extended its alliance with Argenta for comprehensive oncology-focused drug discovery services. The five-year extension will allow both companies to continue to offer expertise in cancer research to their pharmaceutical clients.

PRECOS offers advanced patient-relevant in vivo models that closely reflect the clinical situation for each aspect of cancer progression, encompassing pre-cancerous lesions, primary tumors and metastasis. This ability to create cell lines from patient primary tissues means that cell lines are not selected based on their ability to survive in vitro, but on their true characteristics as cancer cells.

Argenta can now incorporate PRECOS’ in vitro, ex vivo and in vivo cancer models and scientific expertise into its integrated oncology drug discovery service offering, from hit identification through lead optimization and in vivo “proof-of-concept” to clinical candidate selection.

“Argenta has an excellent reputation for providing first class contract drug discovery services to the global pharmaceutical industry; especially in oncology,” said Sue Watson, chief scientific officer, PRECOS. “We are looking forward to working with Argenta across a number of ongoing cancer-focused contract research programs, in addition to various major projects currently in the pipeline. This agreement further demonstrates our business growth and commitment to providing innovative drug discovery services.”
Executive Moves: Quay Pharma

Posted on March 23, 2011 @ 09:21 am

Mark Powell has been appointed Scientific Manager at Quay Pharma. Dr. Powell will take on wider technical responsibility and seek to further raise the scientific profile of the company. Quay provides solid dosage development covering a broad range of formulation types including lipophilic systems, supported by the development of analytical methods for the recovery of API from lipid systems.

Dr. Powell has been with the company for nearly eight years and was previously in charge of the company’s Analytical Development Group. He has experience working in the water industry, serving as a consultant, and as a senior lecturer at Liverpool John Moores University.

“Mark’s in-depth knowledge and skills are invaluable to our client base and in his new role he will help us to consolidate and further develop our reputation and extensive range of specialist services,” said Quay Pharma’s chief executive officer Mike Rubinstein. “We are also delighted that his abilities have gained even wider recognition through his work with the RSC.”

Dr. Powell has also been elected Honorary Treasurer for the Analytical Division of the Royal Society of Chemistry (RSC). In this role, he will oversee the Analytical Chemistry Trust Fund, which helps to support research projects, provides travel grants for overseas students, and promotes an annual schools competition.


Southern, Biomedical in Imaging Pact

Posted on March 23, 2011 @ 09:19 am

Southern Research Institute has signed a services agreement with the Biomedical Research Foundation of Northwest Louisiana that will provide commercial non-invasive preclinical imaging services exclusively for the Southern Research’s scientific research center. The Biomedical Research Foundation will provide radiopharmaceuticals, radiochemistry and radiopharmacy expertise, and other supporting services. In addition, it will provide small animal imaging services and animal care services through a sub-contract with the LSU Health Sciences Center in Shreveport (LSUHSC-S).

“We were very impressed with LSU Health Sciences Center’s imaging facilities, the team there, and their entrepreneurial spirit,” said Andrew D. Penman, Ph.D., vice president of drug development at Southern Research. “This agreement provides us with access to state-of-the-art preclinical imaging facilities, a dynamic research staff at LSUHSC-S, and the opportunity to provide an increasingly important service to our biopharmaceutical clients.”

“Southern Research’s expertise and research successes are well known in our academic community and in industry. We look forward to working with Southern Research as part of its successful drug discovery and development program,” said Jack Sharp, president of the Biomedical Research Foundation.
Aptiv, CGI Enter Clinical Service Alliance

Posted on March 23, 2011 @ 09:16 am

Aptiv Solutions and Cancer Genetics, Inc. (CGI) have formed a strategic partnership to provide comprehensive solutions for the conduct of oncology clinical trials. Aptiv’s services include adaptive trial design, early phase product strategy, regulatory services, pharmacovigilance, and global operational support. CGI provides disease-specific biomarker knowledge, molecular testing and oncology lab services for the early stages of clinical trials.

The goal of the alliance is to provide clients with a better understanding of modes of action of a variety of therapeutics and the role for biomarkers in the oncology drug development process. Using genomic technologies and other methodologies, the alliance aims to provide early insight in complex diseases to help drive informed decisions and the successful development of targeted therapies.

“We are excited about partnering with CGI to enhance our ability to offer molecular and genetic laboratory expertise to our clients,” said Gene Resnick, MD, chief medical officer for Aptiv Solutions. “We recognize the critical role of biomarkers in the development of new agents in oncology and other therapeutic areas, and look forward to bringing a combined solution to the pharmaceutical, biotech and medical device industries which will enable clients to accelerate the progress of more efficient clinical trials. Adding this capacity to our existing expertise in oncology trial management will bring a value-add for sponsors and ultimately for patients.”

“Integrated clinical information is critical to providing customized patient treatment in which drug usage and dosage can be specifically targeted to the individual patient’s genetic requirement,” said Panna Sharma, chief executive officer of CGI. “As a leader in personalized medicine, CGI is confident that this collaboration will assist our clients in the development of new therapeutics and diagnostics by reducing the timeframe and costs for regulatory approval through patient stratification.”
Cephalon To Acquire Gemin X

Posted on March 22, 2011 @ 10:09 am

Cephalon, Inc. has signed a definitive merger agreement to acquire Gemin X Pharmaceuticals, Inc., a privately-held biopharmaceutical company, for $225 million cash. Gemin X stockholders could also receive as much as $300 million in cash payments based on certain regulatory and sales milestones. The agreement is subject to customary closing conditions including the necessary regulatory approvals. The merger is expected to close in 2Q11.

Gemin X is developing a pipeline of targeted cancer therapeutics based on reinitiating programmed forms of cell death, including apoptotic and autophagic cell death, as well as the inhibition of metabolism in cancer cells. Gemin X’s lead product candidate, obatoclax (GX15-070), is a pan Bcl-2 inhibitor currently in Phase II trials in patients with extensive stage small cell lung cancer (ES-SCLC). The trial is evaluating the safety and efficacy of obatoclax as a first line treatment in combination with standard chemotherapy.

“I am pleased to have entered into a merger agreement with Gemin X,” said Kevin Buchi, chief executive officer of Cephalon. “Its array of novel, targeted cancer therapeutics is a welcome addition to our current oncology portfolio. I am particularly excited about Gemin X’s lead compound, obatoclax, which if successful has the potential to significantly benefit patients suffering from small cell lung cancer — a devastating disease for which current treatments are limited and additional therapies are desperately needed.”

Merck, Sanofi End Animal Health JV

Posted on March 22, 2011 @ 10:07 am

Merck and Sanofi-Aventis have terminated their agreement to form a new animal health joint venture by combining their animal health businesses Intervet/Schering-Plough and Merial. As a result, both companies will maintain separate animal health businesses.

The companies are terminating their agreement because of the increasing complexity of implementing the proposed transaction, in terms of the anticipated divestitures and the time it would take for the worldwide regulatory review process. Merck and SA have mutually agreed that ending the agreement is in the best interests of both companies. There are no associated termination penalties and each company is responsible for its own expenses.
Tesaro Acquires Rights to Amgen ALK Program

Posted on March 22, 2011 @ 10:05 am

Tesaro, Inc. has signed an agreement with Amgen to gain exclusive worldwide rights for the development, manufacture, commercialization of small molecule inhibitors of Anaplastic Lymphoma Kinase (ALK). Tesaro plans to develop one or more compounds for oncology indications, including non-small cell lung cancer (NSCLC) in tumors that are ALK-positive. The agreement includes an upfront payment and potential future payments and royalties based on development and commercial milestones. Figures were not disclosed.

Abnormal ALK fusion proteins are thought to be a key driver of certain types of cancers, including NSCLC as demonstrated in recent trials of an ALK inhibitor. Sub-populations of other cancers including lymphoma and neuroblastoma are also associated with abnormal expression of ALK proteins. Amgen’s oral, small molecule ALK inhibitors are highly potent and selective, and have desirable pharmaceutical properties.

“Tesaro is very pleased to announce this license agreement and intends to rapidly complete the necessary studies and activities required for submission of an IND application and advance this promising therapeutic for cancer patients to clinical phase testing,” said Mary Lynne Hedley, Ph.D., president and chief scientific officer of Tesaro. “ALK inhibition shows great promise for a specific and identifiable population of patients. Obtaining rights to this potentially best-in-class program advances our mission to make a difference in the lives of cancer patients and enhances our company’s pipeline of cancer therapeutics and supportive care agents.”
Gerresheimer Acquires Brazilian Manufacturer

Posted on March 22, 2011 @ 10:04 am

Gerresheimer AG has acquired Vedat, a Brazilian manufacturer of plastic pharmaceutical packaging products, in an effort to strengthen its pharmaceutical packaging business in South America. Vedat is located in Sao Paolo, Brazil and employs approximately 450 people.

Vedat’s product portfolio includes plastic closures, PET bottles and other plastic containers and the majority of its customers are based in the South American pharmaceutical industry. Gerresheimer currently manufactures plastic pharmaceutical packaging and plastic medical systems for the South American market at three plants in Brazil and one plant in Argentina.

Uwe Rohrhoff, chief executive officer of Gerresheimer AG, commented, “Expanding in emerging markets is a key component of our growth strategy. The acquisition of Vedat, a technology leader and very profitable company in Brazil, is significantly strengthening our position in the South American pharmaceutical primary packaging market. It perfectly fits our strategy of doubling our sales in the emerging markets from EUR 100 million to EUR 200 million by 2013.”
Financial Report: PDI, Inc.

Posted on March 22, 2011 @ 10:02 am

PDI, Inc.

4Q Revenues: $44.7 million (+94%)

4Q Loss:
$2.6 million (loss of $18.4 million in 4Q09)

FY Revenues: $144.7 million (+80%)

FY Loss: $6.8 million (loss of $33.6 million FY09)

Comments: Sales services segment revenue for the quarter was $41.4 million (+97%) and for the year was $133.3 million (+82%). Marketing services revenue for the quarter was $3.3 million and for the year was $11.3 million, down slightly compared to 2009. Results for the quarter includes a $3.1 million operating loss related to the Group DCA acquisition, and for the year includes the operating loss of $4.3 million, comprised of a $0.5 million from legacy PDI and a $3.8 million from the Group DCA acquisition.
Novartis Gains EU Approval for Gilenya

Posted on March 21, 2011 @ 09:30 am

Novartis received approval from the European Commission for Gilenya (fingolimod) 0.5 mg daily pill for the treatment of highly active relapsing-remitting multiple sclerosis (RRMS), or in patients with rapidly evolving severe RRMS.

The EU application included data showing significant efficacy in reducing relapses, the risk of disability progression, and the number of brain lesions detected by magnetic resonance imaging (MRI).

“This marks another major regulatory approval and we are pleased that Gilenya will become available to more eligible MS patients,” said David Epstein, division head of Novartis Pharmaceuticals. “Novartis is dedicated to bringing innovative new treatments to patients where there is significant unmet need. Gilenya has been in clinical development for MS since 2003 and we are grateful for the commitment of those involved, especially the trial participants, who have contributed significantly to the development of this novel medicine.”

Gilenya, licensed from Mitsubishi Tanabe Pharma, is the first in a new class of drugs called sphingosine 1-phosphate receptor (S1PR) modulators. Gilenya is thought to work by reducing the immune system’s attack on the central nervous system (CNS) by retaining certain white blood cells (lymphocytes) in the lymph nodes, preventing them from reaching the CNS and attacking it.

Genentech aBCC Drug Meets Phase II Endpoint

Posted on March 21, 2011 @ 09:29 am

Genentech’s Phase II study of its investigational Hedgehog Pathway Inhibitor, vismodegib (RG3616/GDC-0449), showed positive results in people with advanced basal cell carcinoma (aBCC), a severe form of skin cancer. The study met its primary endpoint, showing vismodegib shrank tumors in a pre-defined percentage of people in the study. A preliminary safety assessment showed the most common adverse events were consistent with previous vismodegib studies.

“These results are important because people with this disfiguring and potentially life-threatening advanced form of skin cancer currently have no approved treatment options,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “We look forward to presenting the study data in more detail and discussing the results with global health authorities.”

The Hedgehog signaling pathway plays an important role in regulating proper growth and development. Mutations in the pathway that reactivate Hedgehog signaling are seen in several different types of cancer. Abnormal signaling in the Hedgehog pathway is implicated in the majority of BCC cases.
Executive Moves: BioProcess Technology Consultants

Posted on March 21, 2011 @ 09:28 am

Julia Dishman has been appointed manager of sales and marketing for BioProcess Technology Consultants. Ms. Dishman will be responsible for helping to manage the company’s current client portfolio, develop and implement new marketing initiatives, provide customer service and follow-up, and assist with international expansion efforts.

“Julie is a specialist in integrating industry and business knowledge into effective marketing solutions that help drive new business,” said Howard L. Levine, Ph.D., president of BioProcess Technology Consultants. “Her extensive experience working closely with senior management teams in the biotechnology industry to achieve business and sales objectives make her ideally suited for our team. Her fresh perspective and analytical approach will help us expand our consulting services globally,”

Prior to joining the company, Ms. Dishman was an independent biotechnology business development consultant for both product and technology-based start-up companies. She was previously at Merrimack Pharmaceuticals, where she established the business development, market research, and public relations functions.

Almac, Exco InTouch in Technology Alliance

Posted on March 21, 2011 @ 09:19 am

Almac’s Clinical Technologies business unit has formed an exclusive integrated patient management alliance with Exco InTouch that will focus on integrating the technology and processes of each company to deliver patient management, compliance, retention, and ePRO service offerings for clinical trials.

The Almac-Exco InTouch offering seeks to engage, retain, and enhance compliance of patients from the earliest stages of recruitment and throughout the course of a trial. Exco InTouch will work with Almac to integrate its retention and compliance technology solutions with Almac’s IXRS technology, an integrated phone and web platform. This offering will allow patients to receive messages for key elements of their required study conduct using Short Message Service (SMS) text messages, emails, or phone calls.

Almac president Jim Murphy said, “The alliance between Almac and Exco InTouch provides sponsors with a practical, cost-effective solution to managing patients during a clinical trial. Our joint solutions will help enhance patient recruitment, retention and compliance, three highly critical areas of concern for our clients.”

Tim Davis, chief executive officer of Exco InTouch, added, “We are delighted to work with Almac’s clinical technologies business on such a powerful mobile and interactive response solution. Rarely do you have an opportunity to employ a solution that will help all trial participants: the sponsor, the site and the patient. Our clients are already looking forward to taking advantage of this unique Almac-Exco InTouch offering.”

Executive Moves: Catalent Pharma Solutions

Posted on March 18, 2011 @ 09:36 am

Tim McFadden has been appointed vice president and general manager of Consumer Health Softgel at Catalent Pharma Solutions, Inc. Mr. McFadden will be located at Catalent’s headquarters in Somerset, NJ. He replaces Jorge Castro, who is retiring from the company at the end of March.

Mr. McFadden joins the company with more than 20 years of experience in marketing, sales and general management in the consumer healthcare and animal health industries. Most recently, he was executive vice president, sales and marketing, for the pharmaceutical distribution business of Cardinal Health, where he led a team of professionals in the commercialization of pharmaceutical products and value-added services to customers. Prior to that, Mr. McFadden spent 19 years at Pfizer (formerly Wyeth) in the Consumer Health division in a wide range of sales and marketing positions of increasing responsibility.

Dave Heyens, Catalent’s president, Softgel Technologies, said, “We are pleased to welcome Tim to Catalent. He brings an impressive track record of driving top- and bottom-line results and leading high-impact, global teams with a strong sense of customer focus. I also want to thank Jorge for his many contributions during his time with Catalent and wish him well upon his forthcoming retirement.”


Click here to learn more about Catalent.

Quest To Acquire Celera Corp.

Posted on March 18, 2011 @ 09:35 am

Quest Diagnostics, Inc. will acquire Celera Corp. for $671 million, providing Quest with access to genetic tests and an R&D pipeline focused on cardiovascular disease and cancer. The transaction is expected to close the end of April.

Celera focuses on sequencing the human genome and identifying links between genetic variations and disease states. Quest also recently announced plans to acquire the Athena Diagnostics business from Thermo Fisher Scientific Inc. for $740 million in cash. Athena is a provider of diagnostic tests for neurological conditions, including Alzheimer's disease.
Sage Bionetworks, AZ Enter Cancer Pact

Posted on March 18, 2011 @ 09:33 am

Sage Bionetworks and AstraZeneca have entered a collaboration to investigate certain cancers using advanced computational models of disease genetics. The goal is to better match patients with appropriate treatments that might also lead to new cancer therapeutics.

The partnership will leverage Sage Bionetworks’ expertise in computer models of disease genetics with AstraZeneca’s oncology expertise, including access to data on AstraZeneca’s compounds. The focus is to provide data-driven rationales for prioritizing therapeutic targets for developing new insights to improve cancer treatments, as well as potentially helping to identify cancer patient subpopulations that will most likely benefit from such treatments. The financial terms of the deal were not disclosed.

Dr. Jonathan Derry, vice president of research at Sage Bionetworks, said, “This is an exciting opportunity to combine what we have learned about complex genetic networks with the outstanding resources and scientists at AstraZeneca.”

Dr. Susan Galbraith, vice president and head of Oncology Innovative Medicines Unit at AZ, said, “We are looking forward to collaborating with Sage Bionetworks to build realistic, predictive models of cancers to expand our current understanding of these diseases and potentially harness that knowledge into new target identification, portfolio positioning and patient selection all of which we hope will lead to new treatment options for patients.”
Ambrilia, ZBx Enter Licensing Deal

Posted on March 18, 2011 @ 09:32 am

Ambrilia has entered into an agreement granting ZBx Corp. an option to acquire exclusive worldwide rights to Ambrilia's PSP-94 reagents and related intellectual property. If ZBx exercises its option, Ambrilia would be eligible to receive as much as $50,000 upfront, sales milestones, royalties on sales, as well as a percentage of proceeds from any sublicenses or sale of PSP-94. ZBx will cover further development, manufacturing and commercialization costs.

Executive Moves: Pii

Posted on March 17, 2011 @ 09:56 am

Rampurna Prasad Gullapalli has been named vice president of Drug Delivery Technologies at Pharmaceutics International Inc. (Pii). Dr. Gullapalli is responsible for providing strategic scientific and technical leadership in areas of softgel, liquid-filled hard capsules, and novel drug delivery technologies for Pii's contract development and manufacturing business.

"Prasad's extensive background in oral dosage form development adds to Pii's leadership position as a foremost provider of oral dosage form development and GMP manufacturing services to the pharmaceutical industry," said Steve King, senior vice president of Pii. "We look forward to him helping us continually grow our oral formulation development capabilities."

Prior to joining Pii, Dr. Gullapalli served as an associate director of Elan Pharmaceuticals, where he was responsible for preformulation and oral dosage form development. He also served in various scientific positions with increasing responsibilities at Chiron, Purdue Pharma, Banner Pharmacaps and R.P. Scherer (now Catalent).
ARIAD Exercises Ridaforolimus Option

Posted on March 17, 2011 @ 08:57 am

ARIAD Pharmaceuticals, Inc. has exercised its option with Merck & Co. to co-promote ridaforolimus, an investigational mTOR inhibitor, in the sarcoma indication, upon approval in the U.S.

Under the license agreement dating back to May 2010 for the development, manufacture and commercialization of ridaforolimus in oncology, ARIAD has the option to co-promote ridaforolimus with as much as 20% of the sales effort for the product in all indications in the U.S.

“The decision to co-promote ridaforolimus upon potential launch in 2012 is consistent with our plans to build a fully integrated commercial oncology company and dovetails with the potential launch of ponatinib, our investigational pan-BCR-ABL inhibitor, in patients with resistant or intolerant chronic myeloid leukemia in late 2012 or early 2013,” said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD.
Executive Moves: Laureate Biopharmaceutical Services

Posted on March 17, 2011 @ 08:55 am

Ann M. Daus, Ph.D. has been named vice president of Quality at Laureate Biopharmaceutical Services. Dr. Daus will lead the company’s strategic quality plan, recruit new leaders to supplement the quality management team, lead the strategic expansion of testing services and improve companywide systems.

“Ann has the proven leadership experience, personal energy and technical skills required to drive our quality organization and quality processes to the next level as we continue to invest in the business,” said Michael A. Griffith, Laureate’s chief executive officer. “Ann has extensive experience managing change in complex organizations and possesses strong quality and technical management skills.”

Dr. Daus has more than 20 years of experience, including 15 years of management of quality and technical functions including quality assurance, quality control, protein characterization and methods development. Prior to joining the company, she served as vice president of Quality Control & Bioanalytical Sciences for ImClone Systems, Inc., where she led the department that supported the manufacture of both pilot plant and commercial biopharmaceuticals.
Epistem, Sanofi Enter Research Pact

Posted on March 17, 2011 @ 08:54 am

Epistem has entered into a three-year collaboration with Sanofi-aventis U.S., Inc. for the use of Epistem’s biomarker gene expression profiling and immunohistochemistry technologies. Epistem will provide discovery through to clinical biomarker support for Sanofi’s oncology programs. Epistem may receive as much as $4 million in research support payments including certain cost reimbursement.

The collaboration is expected to establish a biomarker strategy aimed at identifying biological responses to drugs in relevant tissues. Activities will cover preclinical, ex vivo and clinical support.

Matthew Walls chief executive officer of Epistem, said, “We are excited at the prospect of working across a range of oncology programs and of applying our technology in collaboration with the team at Sanofi-aventis. This collaboration represents an important milestone for the Company as we continue to exploit our biomarker technologies which are well positioned to support and streamline the drug development process.”
MorphoSys, Boehringer Sign Manufacturing Pact

Posted on March 16, 2011 @ 09:26 am

MorphoSys AG and Boehringer Ingelheim have signed a manufacturing agreement for therapeutic antibodies covering the process development and manufacture of additional clinical material for MorphoSys’s MOR208 program and other drug candidates. MOR208 is a potent monoclonal anti-CD19 antibody in development for the treatment of chronic lymphocytic leukemia and potentially other B-cell malignancies. The program is currently in Phase I development in the U.S. by MorphoSys’s partner Xencor, Inc.

“Adding another supplier to our proprietary development set-up will help to prevent any bottlenecks in clinical trial supply in the years ahead,” said Dr. Marlies Sproll, chief scientific officer of MorphoSys AG. “Also, establishing a commercial manufacturing process with Boehringer Ingelheim early in the development of MOR208 will clearly increase the value of this program.”

Simon Sturge, corporate senior vice president of the biopharmaceuticals division at Boehringer Ingelheim, said, “We believe that the combination of MorphoSys’s successful track record in the discovery and clinical development of antibody-based therapeutics and our proven competence in technical development and manufacturing will be an optimal fit. We look forward to supporting the team at MorphoSys with robust manufacturing processes for clinic and market supply.”
Akrimax Launches NitroMist

Posted on March 16, 2011 @ 09:24 am

Akrimax Pharmaceuticals has introduced NitroMist (Nitroglycerin Lingual Aerosol) 400mcg/spray indicated for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. NitroMist provides nitroglycerin in a rapidly absorbed, mentholated spray formulation designed for use on or under the tongue. NitroMist is available in a fully sealed aerosol delivery system and has a shelf life of 36 months. NitroMist does not contain ethyl alcohol.

Wayne Anderson, Akrimax’ president and chief executive officer, said, “Akrimax is committed to providing health care providers and their patients with therapies that can make an important difference in the lives of patients. We believe NitroMist is an excellent example of this. NitroMist is the second new product that Akrimax has brought to market in the past year. Akrimax also has expanded its sales force by a third in order to educate health care providers about NitroMist and its other promoted brands, Tirosint and Inderal LA.”


Click here to learn more about Akrimax.

Almac Adds Walleting for Clinical Trial Supply

Posted on March 16, 2011 @ 09:22 am

Almac has invested in two ZED automated inline wallet presses at its Craigavon and Pennsylvania facilities. According to the company, the fully automated machines will drastically reduce timelines associated with the use of blister card packaging, compared to current rotary press methods. The automation on the machine is designed for accurate placement of blister strips into the wallet cards. The location and orientation of the blisters is then verified by a vision system prior to sealing the card, helping to keep rejects to a minimum.

Martin Lamb, Almac’s global vice president of business development, said, “The machines are a welcome addition to Almac’s growing portfolio of automated primary packaging services as they demonstrate the company’s continued commitment to innovation and driving improvements across the clinical supply chain. These lines are ideal for larger Phase III trials that can require higher volumes of wallet cards. Also product pooling and using supplies across multiple protocols can drive card quantities past the traditional smaller volumes required for clinical supply. This allows us to provide the client with the right option for their study.”


Click here to learn more about Almac.
RegeneRx AMI Trial Placed on Clinical Hold

Posted on March 16, 2011 @ 09:19 am

RegeneRx Biopharmaceuticals, Inc. has received a notice from the FDA indicating that, due to non-compliance with cGMP regulations by its contract manufacturer, the company’s Phase II trial of RGN-352 has been placed on clinical hold. RGN-352 is an injectable formulation of Thymosin beta 4 in development for the treatment of acute myocardial infarction (AMI). The company was scheduled to begin enrolling patients in the trial in the coming weeks and it is unknown how long the clinical hold will be in place.

The clinical hold is limited to cGMP compliance issues at a specific contract manufacturing site and is not directed at the safety of RGN-352 or the Phase II development protocol. According to the company’s financial filings, it employs a single contract manufacturer for the drug product. As of March 31, 2010, the company was “in the early stages of qualifying backup manufacturers.”
Cytovance to Expand Bio-Manufacturing Capabilities

Posted on March 15, 2011 @ 09:17 am

Cytovance Biologics has secured financing of $22.5 million from Great Point Partners, LLC to invest in the expansion its biologic manufacturing capabilities in Oklahoma City.

The investment will enable Cytovance to expand its clinical trial and commercial scale cGMP manufacturing by funding facility, service and personnel expansion at its research and manufacturing operation in Oklahoma City. Cytovance will move to a nearby facility with laboratories recently vacated by Genzyme. Cytovance also acquired analytical and bioprocess equipment from Genzyme for the expanded facilities.

“Great Point reached out to us last year. It was evident from our first conversation they were very knowledgeable about the biologics manufacturing space and recognized the potential growth opportunities for Cytovance with additional working capital. They share our existing partners’ optimism moving forward and will be a valuable addition to our organization in terms of their vision and understanding of our business,” said Darren Head, chief executive officer of Cytovance. “Great Point’s investment allows us to accelerate our next phase of growth.”

As part of their investment, Great Point managing directors Dr. Jeffrey R. Jay and David Kroin, and senior vice president Noah F. Rhodes, III, will join Cytovance’s board of directors.

Takeda, KINAXO Extend Research Pact

Posted on March 15, 2011 @ 09:06 am

KINAXO Biotechnologies GmbH has entered a second collaboration with Takeda Pharmaceutical Co., under which KINAXO will apply its PhosphoScout technology to assist research of Takeda’s drugs under development. The goal of the collaboration is to allow Takeda to make early decisions on drug efficacy and safety. Financial details were not disclosed.

PhosphoScout enables quantitative analysis of cellular phosphoproteomes on a global scale and provides valuable insights into a drug’s mode of action. PhosphoScout can also identify differentially regulated phosphorylation sites in vivo that may serve as pharmacodynamic or drug response biomarkers in clinical trials.

Dr. Andreas Jenne, KINAXO’s chief executive officer said: “We are very pleased to continue our collaboration with Takeda, a world leading healthcare company, and look forward to supporting Takeda’s efforts in developing drugs. This collaboration once again demonstrates the power of our PhosphoScout platform in drug discovery and development.”

Incyte, Novartis Ruxolitinib Trial Shows Promise

Posted on March 15, 2011 @ 09:04 am

Incyte Corporation’s COMFORT-II, the second Phase III trial of investigational Janus kinase (JAK) inhibitor, ruxolitinib, has met its primary endpoint of significantly reducing spleen size in patients with myelofibrosis (MF), when compared to best available therapy. This trial was conducted by Novartis as part of the Incyte-Novartis worldwide collaboration and license agreement for ruxolitinib.

The study showed treatment with ruxolitinib provided a statistically significant reduction in spleen size in patients with primary MF, post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF), when compared with best available therapy. Also, the safety profile of ruxolitinib was consistent with previous studies.

“The positive results from the European COMFORT-II trial confirm the data from the U.S. trials and further strengthen our confidence that ruxolitinib has the potential to provide myelofibrosis patients, and the physicians who treat them, a new approach to effectively manage this debilitating, life-threatening disease,” stated Paul Friedman, M.D. president and chief executive officer of Incyte. “We and Novartis will continue to work diligently to bring ruxolitinib forward as the first JAK1 and JAK2 inhibitor available to treat MF.”

Data from the COMFORT-II and COMFORT-I trials will be used for worldwide regulatory filings, planned for 2Q11 in the U.S. and the EU. Both the European Commission (EC) and the FDA have granted ruxolitinib orphan drug status for MF.
Executive Moves: ClinTec International

Posted on March 15, 2011 @ 08:59 am

Dr. Stuart Grant has been promoted to associate director of regulatory affairs and medical writing at ClinTec International. Dr. Grant joined the company in 2010 as senior manager of medical writing and regulatory affairs with more than 9 years industry experience. Previously he was a regulatory affairs consultant at a global CRO, where he was responsible for managing Phase I–IV regulatory submissions and study start-up activities. His experience covers several therapeutic and research areas including cardiovascular, respiratory, psychiatry, pharmacokinetics and medical devices.

Dr. Grant stated, “I’m delighted to be given this opportunity within ClinTec. The company is continuing to expand into new geographical regions and pharmaceutical sectors, which inevitably require us to adapt our processes to satisfy the various regulatory requirements. I’m excited to be heading these departments and look forward to the challenges and opportunities that our continuing growth will bring in these areas.”
Lilly Bids for J&J Animal Health Biz

Posted on March 14, 2011 @ 09:19 am

Elanco, Lilly’s animal health division, has made a one-time offer to acquire the animal health business of Janssen Pharmaceutica NV, a Johnson & Johnson company. Janssen’s animal health business, headquartered in Beerse, Belgium, is focused on targeting disease segments in companion animals and livestock, with special emphasis on swine and poultry.

Should the deal close, Elanco would obtain a portfolio of about 50 marketed animal health products, as well as the transfer of Janssen’s animal health employees. Manufacturing facilities would not be included in the transaction, which is subject to customary closing conditions. Financial terms were not disclosed.

“The addition of Janssen’s animal health business will strongly support a number of strategic growth priorities for Elanco, while providing synergies with our current operations,” said Jeff Simmons, Lilly senior vice president and president of Elanco. “Through this transaction, we intend to further expand our European presence, bolster our growing portfolio of companion animal medicines and diversify our food animal portfolio with new swine and poultry products. We are excited about these new opportunities to improve animal health, food safety and food animal production while delivering greater value to our customers.”

PROLOR Biotech Expands R&D Facility

Posted on March 14, 2011 @ 09:17 am

PROLOR Biotech, Inc. is relocating its corporate office and R&D facility to a new, larger building located near its current site in the Weizmann Science Park in Nes Ziona, Israel.

The new headquarters and upgraded R&D facility comprise approximately 10,000 sq. ft. of leased space, allowing for growth in all areas, including new drug research and clinical development. The expanded R&D facility includes clean rooms for GMP-grade production of therapeutic drug candidates for the production of a variety of therapeutic proteins for R&D applications.

“We are excited that this move gives us the opportunity to upgrade our R&D facility, allowing for the planned expansion in R&D headcount and activity needed to accomplish the ambitious goals we have set for our clinical development and research programs in 2011 and 2012,” said Shai Novik, president of PROLOR. “This new facility makes it possible for us to strengthen our capabilities across the board, and we intend to leverage it fully to help accomplish our stated milestones.”
Executive Moves: Catalent

Posted on March 14, 2011 @ 09:16 am

Lance Miyamoto has been appointed senior vice president of Human Resources, Catalent Pharma Solutions, Inc. Mr. Miyamoto will be located at the company’s headquarters in Somerset, NJ. He replaces Harry Weininger, who is retiring from the company.

Mr. Miyamoto has more than 25 years of human resources experience. Prior to his own consulting business, he was an executive vice president of Comverse Technology, Inc., where he led all aspects of the global human resources function and worked directly with the board of directors to revise all people-related company practices and create stronger governance. His previous positions include executive vice president of HR for AOL LLC, member of the Human Resources Council, and executive vice president of HR for Lexis-Nexis.

John Chiminski, Catalent’s president and chief executive officer, said, “We are pleased to have Lance join the Catalent executive team. He brings experience and proven expertise in delivering HR systems that drive business results and growth. I also want to thank Harry for his many contributions during his time with Catalent and wish him well upon his forthcoming retirement.”
Executive Moves: Labopharm

Posted on March 14, 2011 @ 09:14 am

Mark D’Souza has been appointed president and chief executive officer of Labopharm and a member of the board of directors. Mr. D’Souza previously served as the company’s chief financial officer. “We are delighted to have Mark’s knowledge and experience to lead the corporation forward,” said Santo J. Costa, Labopharm’s chairman.

Mr. D’Souza replaces James Howard-Tripp, who will step down from his role. “We are very grateful to Jim for his efforts on behalf of the Corporation over the last 11 years,” said Mr. Costa.

Labopharm also announced that the board of directors, together with the company’s management, has undertaken a complete review of the business, including consideration of all available strategic options.
J&J Unit Signs Consent Decree for U.S. Facilities

Posted on March 11, 2011 @ 09:53 am

McNeil-PPC, Inc., a Johnson & Johnson subsidiary, has finalized the terms of a Consent Decree with the FDA. The decree covers manufacturing facilities operated by the McNeil Consumer Healthcare Division in Las Piedras, PR, Fort Washington, PA, and Lancaster, PA. The Consent Decree is subject to approval by the U.S. District Court of Pennsylvania.

In July 2010, McNeil submitted a Comprehensive Action Plan (CAP) to improve quality systems at its U.S. manufacturing facilities. McNeil believes that the terms of the consent decree recognize remediation efforts to date, consistent with its commitments as part of the CAP.

Under the terms of the consent decree, the company will continue to operate the manufacturing facilities in Las Piedras, PR and Lancaster, PA and will work with an independent expert who will inspect these sites and issue recommendations for remediation to address any observations identified. These plans will be submitted to the FDA and are subject to the agency’s approval. The independent expert will also review certain manufacturing records at the two sites while remediation is ongoing to ensure quality standards of products released from the sites. The company expects that the consent decree will oversee its operations for at least five years following the completion of the remediation plan.

In April 2010, the company voluntarily closed its manufacturing facility in Fort Washington, PA and announced that it would not re-open the plant until it completed remediation efforts at that facility.
FDA Approves Dendreon Expansion

Posted on March 11, 2011 @ 09:51 am

Dendreon Corp. received approval from the FDA for the expansion of its NJ manufacturing facility, allowing the company to significantly increase the availability of Provenge (sipuleucel-T), a treatment for metastatic castrate resistant (hormone refractory) prostate cancer.

The FDA approved Provenge last April. At that time Dendreon had 12 workstations at its NJ facility to supply the drug. The FDA has approved 36 additional workstations, bringing the total workstation count to 48. With the additional workstations, Dendreon expects to have approximately 225 infusion centers prepared to treat their first patient by the end of the 2Q11, approximately 450 infusion centers by 4Q11, and approximately 500 by the end of the year.

“The significant 4.1 month median survival benefit PROVENGE demonstrated represents a major milestone in the treatment of metastatic CRPC. To put Provenge in perspective, over the past 15 years, there have only been three other therapies in any metastatic cancer setting to show a survival benefit of four months or more,” said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. “With FDA approval of the additional NJ workstations, we now have significant capacity to make this important therapy available to the many men across the U.S. who may benefit from it.”

Tolerx, GSK Diabetes Study Misses Endpoint


Posted on March 11, 2011 @ 09:50 am

Tolerx and GlaxoSmithKline’s Phase III DEFEND-1 study of otelixizumab, an investigational humanized anti-CD3 monoclonal antibody, did not meet the primary efficacy endpoint in patients with new-onset autoimmune type 1 diabetes.

Preliminary data did not show new or unexpected treatment-related safety concerns during the study. GSK will continue to explore additional dosing regimens in the clinical development program for otelixizumab. New recruitment and dosing in the DEFEND-2 study, the ongoing confirmatory Phase III study with a design similar to DEFEND-1, has been suspended pending review of the DEFEND-1 results.

“While we are disappointed in the DEFEND-1 results of otelixizumab, we remain committed to the development and commercialization of the candidates in our pipeline, each of which has a distinct mechanism and target for correcting abnormal immune responses,” said Douglas J. Ringler, VMD, president and chief executive officer of Tolerx. “Our immunotherapy candidates represent some of the latest scientific advances in harnessing the immune system for therapeutic benefit, including TRX518 which is a showpiece of our pipeline as an immunotherapy to treat cancer.”

Sanofi, Regeneron Lung Cancer Trial Misses Endpoint

Posted on March 11, 2011 @ 09:49 am

Sanofi-aventis and Regeneron Pharmaceuticals’ Phase III VITAL trial evaluating the investigational drug aflibercept (VEGF Trap) for the second-line treatment of non-small cell lung cancer (NSCLC) showed that adding aflibercept to the chemotherapy drug docetaxel did not meet the primary endpoint of improvement in overall survival compared with docetaxel plus placebo. The addition of aflibercept to docetaxel demonstrated activity in key secondary endpoints of the study: progression free survival (PFS) and an overall objective response rate (ORR) of 23.3% in the aflibercept arm compared to 8.9% in the placebo arm.

The adverse events (AEs) on the aflibercept arm were 10% greater than the control arm and included stomatitis, weight loss, hypertension, epistaxis and dysphonia. AEs leading to treatment discontinuation occurred in 27.2% of patients in the aflibercept arm compared to 14.6% in the placebo arm.

“Bringing new and innovative cancer therapies to patients can be incredibly challenging, especially in difficult-to-treat cancers such as second-line non-small cell lung cancer,” said Debasish Roychowdhury, senior vice president and head of Global Oncology Division, Sanofi-aventis. “Our Phase III trials of aflibercept in metastatic colorectal cancer and hormone-refractory metastatic prostate cancer are underway to determine the clinical potential of aflibercept for patients with these advanced cancers.”
GNS, Biogen Idec Identify RA Drug Targets

Posted on March 11, 2011 @ 09:47 am

GNS Healthcare and Biogen Idec published results from a study focused on identifying novel drug targets for the one-third of rheumatoid arthritis patients who do not respond to leading anti-TNF therapies.

The study resulted in an experimental and computational approach for researchers to integrate clinical, molecular and genetic data into models of disease progression and drug response. This approach helped predict individual patients’ clinical responses to the shutting down of specific pathways, suggesting that accurate determinations can be made about patients’ responses to existing drugs as well as the inhibition of novel targets and pathways based on DNA and gene expression data from a given patient’s blood.

The researchers used GNS’ supercomputer-driven REFS (reverse-engineering and forward-simulation) scientific computing platform to construct a comprehensive disease model directly from the raw data. This computer disease model enabled the team to conduct virtual clinical trials, simulating the clinical effect of inhibiting various drug targets and predicting novel and previously known alternative genetic targets to anti-TNFs.

“This project established that a relatively small, heterogeneous clinical trial dataset could be directly used to learn novel disease biology if one has access to a significantly powerful computational modeling platform. This is the first time that a patient-data driven, computer model of rheumatoid arthritis has been developed to generate patient-specific predictions to the response to existing drugs and the response to inhibiting novel targets and pathways of the disease,” said Colin Hill, chief executive officer and co-founder of GNS Healthcare.

Executive Moves: Eli Lilly and Co.

Posted on March 10, 2011 @ 09:29 am

Greg Plowman, M.D., Ph.D., has been appointed to lead Lilly’s oncology research efforts as the vice president of oncology research, and senior vice president of ImClone Systems research. Dr. Plowman will oversee the oncology research efforts of both Lilly and its subsidiary, ImClone, and will be based at ImClone’s Alexandria Center for Life Science in New York City. He reports to Jan Lundberg, Ph.D., executive vice president, science and technology, and president, Lilly Research Laboratories (LRL), and Bernhard Ehmer, M.D., president of ImClone.

“Oncology represents a major area of unmet medical need and rapidly advancing science is driving us to discover new treatments with better efficacy to prolong the survival of the patients we serve,” said Dr. Lundberg. “The introduction of a new oncology research leader across Lilly and ImClone will ensure the pursuit of the right mechanisms, therapeutic agents and tailoring strategies across our oncology business. Greg’s position is unique and his experience makes him an ideal choice for this new position.”

Most recently, Dr. Plowman served as a senior director in research for six years at Genentech, a member of the Roche Group. He directed research efforts in anti-angiogenesis, biomedical imaging, and tumor biology, and was responsible for building a pipeline of new agents for treatment of cancer and ocular disease. He has 25 years of experience in cancer research including leadership roles at Oncogen, Sugen, Exelixis and Genentech (now Bristol-Myers Squibb, Pharmacia and Roche).

Epizyme, Eisai Enter Epigenetic Enzyme Engagement

Posted on March 10, 2011 @ 09:26 am

Epizyme, Inc. has entered a worldwide partnership with Eisai Co. to discover, develop and commercialize therapeutics targeting EZH2, an epigenetic enzyme, for the treatment of lymphoma and other cancers. Epizyme will receive $6 million upfront and is eligible to receive more than $200 million in additional R&D and sales milestones, as well as royalties. Eisai will fund all research through human proof-of-concept, at which point Epizyme can opt into a profit share and co-commercialization agreement in the U.S.

“Eisai is committed to bringing epigenetic therapeutics to cancer patients,” said Takashi Owa, Ph.D., president, Oncology Product Creation Unit, Eisai Product Creation Systems. “Epizyme’s proprietary product platform, leadership in determining the oncogenic role of EZH2 in genetically-defined cancers, and success in discovering novel, potent, and selective small molecule inhibitors of histone methyltransferases (HMTs), an important epigenetic target class, led us to them as the partner of choice in epigenetic drug discovery.”

“Our partnership with Eisai reflects our shared belief in the therapeutic potential of this area and is an important element in the ongoing execution of our strategy to build a leading new biopharma company by bringing innovative personalized therapeutics to genetically-defined cancer patients,” said Robert Gould, Ph.D., president and chief executive officer of Epizyme. “The U.S. profit-share and co-commercialization option is a key element of our strategy to discover, develop and also to commercialize epigenetic medicines.”

Financial Report: Patheon 1Q11

Posted on March 10, 2011 @ 09:23 am

Patheon 1Q11

1Q Revenues: $175.7 million (+12%)

1Q Loss: $500,000 (loss of $11.1 million 1Q10)

Comments: Commercial manufacturing revenues were up 16% to $148.7 million. North American commercial revenues were $5.1 million (+9%). European commercial revenues were $15.5 million (+22%). Pharmaceutical Development Services revenues were $27.0 million (+1%). European commercial revenues benefited from a $30 million reservation payout by a client that chose not to continue a lyophilized cephalosporin project after receiving a complete response letter.


Click here to learn more about Patheon
Catalent’s Schorndorf Facility Marks 50 years

Posted on March 10, 2011 @ 09:21 am

Catalent Pharma Solutions celebrates the 50th anniversary of its Schorndorf, Germany facility, which specializes in modified release technologies and clinical supply services.

The Schorndorf facility first opened in 1961 as Allpack and grew to serve the pharmaceutical industry in service areas such as clinical supply, manufacturing, quality assurance and R&D. In recent years, the facility doubled GMP production capacity, built a new distribution center for clinical trial medication, and doubled its lab space.

“We are extremely proud of Schorndorf’s rich 50-year history and proven excellence in providing a full-range of services and innovative solutions to meet the increasingly complex needs of our customers,” said Ian Muir, Ph.D., president, Modified Release Technologies, Catalent Pharma Solutions. “Our focus on reliability combined with our diverse employee base, and long-term customer partnerships, have made us successful in broadening Schorndorf’s roots and optimizing our offerings.”

The Schorndorf facility has been supporting global pharmaceutical companies such as Lilly. “Over the years Lilly has established an enduring partnership with Catalent Germany Schorndorf GmbH,” said Sherman Whitfield, director, Office of Alliance Management, Lilly.


Click here to learn more about Catalent
FDA Approves Benlysta for Lupus

Posted on March 10, 2011 @ 09:19 am

Human Genome Sciences, Inc. and GlaxoSmithKline received approval from the FDA for Benlysta (belimumab) for the treatment of autoantibody-positive systemic lupus erythematosus (SLE) in patients receiving standard therapy. Benlysta is the first in a new class of drugs called BLyS-specific inhibitors. Belimumab blocks the binding of soluble BLyS, a B-cell survival factor, to its receptors on B cells.

“We and GSK are honored to have the opportunity, with the approval of FDA, to bring Benlysta forward in the U.S. as the first new drug for systemic lupus in more than 50 years,” said H. Thomas Watkins, president and chief executive officer, HGS.

Moncef Slaoui, Ph.D., chairman, GSK R&D, said, “The approval of Benlysta is an important step for appropriate lupus patients. Patients have been waiting for new treatment options to help manage this chronic disease. We look forward to working together with HGS to bring this new medicine to patients in the U.S.”

GSK submitted a MAA for Benlysta to the EMA in June 2010. Regulatory applications have also been submitted in Canada, Australia, Switzerland, Russia, Brazil and The Philippines.
BMS, KineMed Extend Alzheimer’s Pact

Posted on March 9, 2011 @ 09:28 am

Bristol-Myers Squibb and KineMed, Inc. have extended their research collaboration in the area of Alzheimer’s disease and other neurodegenerative conditions. Under the extension, BMS has non-exclusive license to KineMed’s technologies to identify and characterize biomarkers for Alzheimer’s disease in cerebrospinal fluid.

“Understanding what is going on in the living brain is key to drug development in neurodegenerative diseases. We can measure fundamental brain processes in a living person that have never been measured before. KineMed is enabling research on potential treatments that address the causes, rather than the symptoms, of disease,” said David Fineman, president and chief executive officer of KineMed, Inc.

“Quantifying the dynamics of causative pathogenic processes such as neuronal transport gives pharma companies a tremendous advantage in monitoring drug efficacy,” commented Marc Hellerstein, M.D., Ph.D., head of KineMed’s Scientific Advisory Board and Calloway Chair Professor at UC Berkeley and Professor of Medicine at UCSF School of Medicine.
Aeterna Zentaris, Yakult Honsha In Onco-Development Pact

Posted on March 9, 2011 @ 09:27 am

Aeterna Zentaris, Inc. and Yakult Honsha Co. have signed an exclusive development, commercialization and licensing agreement for Aeterna Zentaris' lead anti-cancer compound perifosine, in Japan. Perifosine, a novel oral PI3K/Akt inhibitor, is currently in Phase III development for the treatment of colorectal cancer and multiple myeloma in the U.S. and Europe.

Aeterna Zentaris will receive $8.3 million upfront and is eligible to receive as much as $60.9 million if certain milestones are achieved. Aeterna Zentaris will be supplying perifosine to Yakult Honsha on a cost-plus-basis and is entitled to receive royalties on sales of perifosine in Japan. Yakult Honsha will be responsible for the development, registration and commercialization in Japan.

"We are delighted to have a partner such as Yakult Honsha who has a proven track record in oncology and particularly in colon cancer, one of the main indications being targeted with perifosine. This partnership marks another important milestone in our quest to bring perifosine to market worldwide, which could provide cancer patients with a novel treatment option. Furthermore, perifosine could generate significant long-term revenue for Aeterna Zentaris while building value for our shareholders," said Juergen Engel, Ph.D., president and chief executive officer of Aeterna Zentaris.

Mr. Shigeyoshi Sakamoto, head of the Pharmaceutical Division and managing director of Yakult Honsha, said, "We are delighted to have added perifosine to our pipeline in oncology, which we have positioned as our key therapeutic domain. We look forward to pursuing development and commercialization of perifosine in Japan, by efficiently utilizing the data of ongoing Phase III trials in the U.S. and Europe for patients with colorectal cancer and multiple myeloma. This partnership will enable us to further strengthen our initiative in the field of colorectal cancer and to embark on new fields including multiple myeloma."
Financial Report: WuXi PharmaTech

Posted on March 9, 2011 @ 09:25 am

WuXi PharmaTech

4Q Revenues: $88.6 million (+20%)

4Q Earnings:
$17.3 million (+42%)

FY Revenues: $334.1 million (+24%)

FY Earnings:
$90.8 million (+72%)

Comments: Growth in the quarter was driven by Lab Services revenue (+16%) and a 59% increase in Manufacturing Services revenues. For the year, growth was driven by both China- and U.S.-based Lab Services revenue (+18%) and 95% growth in Manufacturing Services revenues. In the quarter, earnings include a 38% growth in income from continuing operations and the non-recurrence of a loss from discontinued operations in 4Q10. FY earnings include a 30% increase in operating income and a favorable change in other income (expenses).


Stemline AML Drug Gains Orphan Status

Posted on March 9, 2011 @ 09:23 am

Stemline Therapeutics’ lead compound SL-401 has received Orphan Drug designation from FDA for the treatment of acute myeloid leukemia (AML). The orphan designation helps to support the development of new therapies that treat rare diseases and offers incentives such as seven years of marketing exclusivity, tax credits, and clinical development grants, as well as a waiver of Prescription Drug User Fee Act (PDUFA) filing fees.

SL-401 has completed a multi-center Phase I/II trial in AML demonstrating single agent efficacy, including two durable complete responses (CRs), multiple blast reductions and disease stabilizations, as well as an overall survival (OS) benefit in heavily pre-treated patients. SL-401 was well tolerated and bone marrow-sparing. SL-401 will now enter Phase III trials in patients with advanced AML.

Stemline's chief executive officer, Ivan Bergstein, said, "Receipt of Orphan Drug designation represents another key milestone in the advancement of SL-401 through the regulatory process. We are also very encouraged by the potential of SL-401 to benefit patients with advanced stage AML, an unmet medical need, as well as additional hematologic malignancies including MDS, CML and potentially certain lymphomas."
Executive Moves: Hospira, Inc.

Posted on March 8, 2011 @ 09:21 am

F. Michael (Mike) Ball has been appointed chief executive officer of Hospira, Inc. and a member of the board, effective March 28, 2011. He succeeds the company's founding CEO, Christopher B. Begley, who will assume the role of executive chairman.

Mr. Ball currently serves as president of Allergan, Inc., where he has spent the past 16 years of his career. During this time, Mr. Ball was responsible for accelerating growth in international markets and leading the strategy and execution of global commercial activities for specialty pharmaceuticals, OTC products and surgical devices.

"From the outset of our CEO search, the board and I were determined to identify a candidate who would extend Hospira's growth trajectory, expand our global reach, and inspire our employees as we continue our patient-focused journey to sustainable top-tier financial performance," said Mr. Begley. "With his proven track record of growing complex global businesses, demonstrated success in leading diversified healthcare portfolios and strong commitment to creating value for all company stakeholders, we found the perfect fit with Mike Ball. We are thrilled to welcome Mike to the Hospira family, and I look forward to partnering with him and our board to continue to advance our great company."

Mr. Ball said, "I am deeply honored and excited to join Hospira's 14,000 employees in advancing our shared passion to increase patient and caregiver safety and productivity, reduce the high costs of healthcare, and provide the highest quality products that address critical unmet needs around the globe. With our strong financial position, market leadership and talented workforce, Hospira is uniquely positioned to capitalize on our exceptional growth potential while we create value for our employees, customers, shareholders and global communities."
RainDance Technologies, Ambry Genetics Enter ADME Pact

Posted on March 8, 2011 @ 09:17 am

RainDance Technologies, Inc. and Ambry Genetics have entered a collaboration focused on the development and commercialization of a comprehensive drug absorption, distribution, metabolism, and excretion (ADME) genetic screening panel for use on next-generation sequencing (NGS) systems. Financial terms were not disclosed.

The new ADME panel leverages RainDance's primer design methods and microdroplet-based RDT 1000 platform. It’s designed to provide scientists with the capacity to perform sequence analysis of entire coding regions associated with more than 220 key drug metabolism-linked genes including transporters, receptors, regulators and all pharmacodynamics and pharmacogenetic genes, as well as all FDA-identified pharmacogenomic biomarker genes.

"Scientists interested in analyzing ADME-linked genes can now look far beyond what existing genotyping panels reveal and discover the novel chromosomal changes and rare variants associated with drug metabolism and molecular pharmacology," said Darren Link, Ph.D., co-founder and vice president of R&D at RainDance Technologies. "Through our collaboration with Ambry Genetics, we are providing a solution that puts the most advanced ADME research tools within reach of the many research organizations focused on reducing the significant costs associated with failed drug trials and avoidable hospitalizations."

"We are very pleased to be working closely with RainDance and to be the first service provider delivering this innovative and first-of-its-kind ADME sequencing service," said Ardy Arianpour, vice president of business development at Ambry Genetics. "We are confident that our pharmaceutical, biotechnology and research customers will be eager to utilize this novel predictive toxicology tool to enhance their safety strategies and reduce the costs associated with performing ADME analysis across the many research projects and clinical trials that rely on these critical data."
Eisai Restructures U.S. Operations

Posted on March 8, 2011 @ 09:00 am

Eisai, Inc., a U.S. subsidiary of Eisai Co., Ltd., plans to restructure its operations, cutting approximately 20% of its workforce across all U.S. functions, resulting in the loss of 600 positions by April 1, 2011. The restructuring is part of Eisai’s global strategic plan for FY2011-2015, to become a more efficient and focused organization.

The company plans to focus on advancing its oncology portfolio and launch new neuroscience assets. Eisai’s U.S. operations include R&D, manufacturing, sales and marketing, and administrative functions.

“This restructuring is essential to our remaining competitive in this rapidly changing environment,” said Lonnel Coats, president and chief executive officer of Eisai Inc. “It will enable us to continually make the necessary investments in our science, our people and ultimately our human health care (hhc) mission, while ensuring an adequate return to our shareholders.”
FDA Accepts Dapagliflozin NDA

Posted on March 8, 2011 @ 08:58 am

Bristol-Myers Squibb and AstraZeneca’s NDA for dapagliflozin, an investigational drug for the treatment of type 2 diabetes, has been accepted by the FDA. Also, a MAA for dapagliflozin has been validated by the EMA. Both submissions were filed in December 2010. The Prescription Drug User Fee Act (PDUFA) goal date for the FDA is October 28, 2011.

The submissions included two years of data from a global development program involving approximately 6,000 individuals in 40 clinical studies. The U.S. application also includes data assessing the cardiovascular safety of dapagliflozin in adults with type 2 diabetes.

If approved, Dapagliflozin would be the first in a new class of drugs that inhibits sodium-glucose cotransporter-2 (SGLT2), which is designed to help control glycemia independently of insulin pathways, leading to the excretion of excess glucose.
BMS, WuXi PharmaTech in Shanghai Stability Pact

Posted on March 7, 2011 @ 09:17 am

Bristol-Myers Squibb and WuXi PharmaTech have entered a strategic partnership to conduct stability studies of small-molecule new chemical entities to support global marketing applications. WuXi will build and operate a dedicated, 25,000-sq.-ft. cGMP analytical testing facility in Shanghai to store and test stability samples and perform other services for BMS. WuXi will also employ a staff for stability testing, sample management, analytical testing, pharmaceutical science, quality assurance, metrology and other services, including stability data reporting to support BMS’ global dossier submissions.

“This new agreement expands our already productive relationship with BMS, a valued customer for many years,” said Ge Li, Ph.D., chairman and chief executive officer of WuXi PharmaTech. “We will continue to help them to improve their R&D productivity with our innovation-driven, cost-effective and fully integrated R&D service platform.”

“WuXi PharmaTech is an important partner for BMS’ R&D organization,” said Mark Powell, Ph.D., senior vice president, Non-Clinical Development, BMS. “This agreement will expand the scope of our relationship with WuXi and enhance the presence of BMS in China. It is also an example of our R&D organization executing our company’s BioPharma model by using selective integration to leverage the strengths and talents of both Bristol-Myers Squibb and a valued partner.”
Covance Gets AAALAC Accreditation in Shanghai

Posted on March 7, 2011 @ 09:16 am

Covance, Inc. was awarded full accreditation for its early development research facility in Shanghai, China from the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC). The Shanghai facility provides bioanalytical, toxicology, lead optimization toxicology, in-vivo PK screening and metabolism services. Through voluntary accreditation and assessment programs, AAALAC promotes the humane treatment of animals in science and recognizes the highest standards for animal care and use in 34 countries.

“Covance takes very seriously our obligations to the animals in our care. The unanimous approval from AAALAC International for full accreditation with no additional recommendations for improvement affirms that we adhere to the highest standards of animal care,” said Honggang Bi, corporate vice president and general manager, Covance China. “The Council on Accreditation of AAALAC International commended the management and staff at the Shanghai facility for providing institutional and administrative commitment to the animal care program as evidenced by our newest facility, equipment, and programs.”
GEA Pharma Systems Expands Into Nordic Market

Posted on March 7, 2011 @ 09:14 am

GEA Pharma Systems has partnered with Christian Berner Tech Trade to sell its range of GEA solid dosage technologies in Sweden and Norway, expanding GEA Pharma’s market reach in the region. The agreement covers the supply and servicing of granulation and drying equipment of Aeromatic-Fielder and Collette, the pelletizing and coating technologies of Aeromatic-Fielder, including NICA System, and the contained materials handling technologies of Buck.

Frans K.A. Maas, vice president sales and marketing for GEA Pharma Systems, said, ”The new agreement will provide an excellent service network enabling us to react more quickly to our customers’ requirements for high quality service and supply of market leading solid dosage technology.”

Dr. Bo Söderqvist at Christian Berner Tech Trade said, “This new range of products fits well with our strategy to expand within the pharmaceutical processing industry, and we are exited to be able to present these well proven and market leading technologies.”
Marken Adds Capabilities in Singapore

Posted on March 7, 2011 @ 09:12 am

Marken has relocated and expanded its Singapore office to support specialty logistics services for clients. The expansion includes a new purpose-built GMP compliant facility to support investigational medical product distribution, as well as the addition of key specialty services for its programs in the Asia Pacific and Middle East regions.

The new 14,500-sq.-ft. clinical trial supply depot offers storage conditions including: secured controlled drug (ambient), 15° – 25°C (controlled ambient), -2° – 8°C (cold storage), -20°C (frozen), and -80°C (deep frozen). Clinical trial logistics services include: storage and distribution, drug returns and destruction, kit building, and short- and long-term biological specimen storage in ultra low freezers.

Gerard Barba, chief executive officer of Marken, commented, “The opening of our directly owned depot in Singapore sets the cornerstone of an expanding global network of GMP compliant distribution centers for Marken.”
Ventrus Contracts inVentiv, Almac for Phase III Trial

Posted on March 4, 2011 @ 09:03 am

Ventrus Biosciences has selected inVentiv Clinical Solutions to manage its Phase III trial with Iferanserin in development for the treatment of hemorrhoids. Ventrus has selected Almac Group to provide electronic patient-reported outcomes solutions.

Ventrus plans to initiate its first Phase III trial in 2011 and expects data in 1Q12. The study will enroll 400 patients who will be randomized to receive placebo or Iferanserin. The primary endpoint is cessation of bleeding.

Russell Ellison, chief executive officer of Ventrus, said, “During our selection process, we were looking for strategic partners who have a proven track record with gastrointestinal studies and track record of success. inVentiv and Almac rose above the other research organizations and we are delighted to be working with them.”


Click here to learn more about Almac Group

Executive Moves: ISP Pharmaceuticals

Posted on March 4, 2011 @ 09:01 am

Dr. Yunxia (Vivian) Bi has been appointed Technical Director of ISP Pharmaceuticals Solubility Initiative. In this newly created position, Dr. Bi will oversee development of technical data and information to support the use of ISP’s solubility-enhancing ingredient portfolio and solid dispersion development services by pharmaceutical formulators. Dr. Bi has experience in oral drug delivery systems formulated for bioavailability enhancement, and is author of more than 40 research papers and abstracts in formulation research. Prior to joining the company, Dr. Bi served as associate principal scientist at AstraZeneca.

“ISP is pleased to appoint a scientist with experience in confronting the challenges in developing poorly soluble drugs to lead this important R&D initiative. Dr. Bi knows the processes pharmaceutical makers follow when formulating poorly soluble entities and the general pathways pharmaceutical makers follow when commercializing such entities. We are confident Dr. Bi will be an asset to companies that want to reduce the development timeline and costs associated with the development of poorly soluble drugs,” said Philip Strenger, senior vice president Global Pharmaceuticals, ISP.
Executive Moves: Pillar5 Pharma

Posted on March 4, 2011 @ 08:59 am

Dan DeVido has been appointed business development manager at Pillar5 Pharma, Inc. He joins Jocelyn Larose, director business development, on the business development team.

Working from the North Carolina area, Mr. DeVido will be responsible for developing new business and will play a critical role in extending the company’s reach to new customers in the U.S. market. Mr. DeVido has an extensive background in contract manufacturing in both sales and technical areas.

“I am very excited about Dan joining our organization to enhance our Business Development efforts,” said Pillar5’s president and chief executive officer, John Carkner. “The Business Development Team is responsible for managing existing accounts and generating new business opportunities for Pillar5. Dan’s technical expertise and industry knowledge will further enhance Pillar5’s market position as an innovative and capable contract manufacturing partner.”


Click here to learn more about Pillar5Pharma
Corgenix, Randox Complete IT Assay

Posted on March 4, 2011 @ 08:57 am

Corgenix Medical Corp. has successfully completed the feasibility stage for a new, high-speed automated test format for its AspirinWorks Test, developed in collaboration with Randox Laboratories. The new format was created to make it faster and easier to perform the AspirinWorks Test at clinical labs and hospitals.

“We’ve taken another critical step forward in expanding the potential market for the AspirinWorks Test,” said Douglass Simpson, Corgenix president and chief executive. “The next step in this process will be the launch of the new fully automated immunoturbidimetric (IT) format, making it easier and faster to process large volumes of this important cardiovascular test.”

Once completed and approved by the FDA, the new IT assay will be compatible with automated chemistry analyzers. The assay will be manufactured at Randox Laboratories in the UK, and the two companies will share global distribution rights.
Charles River To Supply Pfizer’s Research Models

Posted on March 3, 2011 @ 09:22 am

Charles River Laboratories and Pfizer have entered into a marketing and distribution agreement to provide certain Pfizer-developed genetically modified research models to the biomedical research community. Charles River will supply pre-competitive, transgenic research models developed by Pfizer covering a range of therapeutic areas, including neuroscience, diabetes and cardiovascular disease.

“Charles River is extremely pleased to partner with Pfizer to further expand our growing portfolio of genetically modified research models that we can make available to our global client base,” said Dr. Iva Morse, corporate vice president, Global Research Model Services at Charles River. “The use of genetically modified research models continues to emerge as an important tool to allow scientists in their research to target specific disease states and genetic markers. We appreciate that Pfizer has selected Charles River to bring their unique models to market.”

Rick Connell, vice president and worldwide head of External Research Solutions Center of Excellence at Pfizer, added, “This agreement with Charles River aligns with Pfizer’s strategy to externalize our pre-competitive tools and assets to a broader community of scientists outside of Pfizer’s walls. We collectively share an interest in seeing science advance to enable the continued development of innovative medicines for patients. Charles River is a leader in providing products and services to the biomedical research community, so we expect that our genetically modified models will be delivered to their clients with the highest standards of quality and care for which they are globally recognized.”
Lycera, Merck Enter Autoimmune Research Pact

Posted on March 3, 2011 @ 09:21 am

Lycera Corp. and Merck have entered into an exclusive research collaboration to discover, develop and commercialize drug candidates to treat autoimmune diseases such as rheumatoid arthritis, psoriasis, inflammatory bowel disease and multiple sclerosis, with small molecules that target T-helper 17 (Th17) cells, key mediators of inflammation.

Lycera will collaborate with Merck, through an affiliate, on discovery efforts and preclinical development targeting the retinoic acid related orphan receptor (RORγt). Merck is responsible for clinical development and will have worldwide marketing and commercialization rights to any resulting products, while Lycera retains a profit share option in the U.S. Lycera will receive $12 million upfront, research funding, and is eligible to receive as much as $295 million in R&D and regulatory milestone payments, as well as royalties and sales milestones.

“We are delighted to be working with Merck, which brings industry leading expertise in drug discovery, development and commercialization to this collaboration,” said Gary D. Glick, Ph.D., Lycera founder and chief scientific officer. “This joint partnership is a significant validation of Lycera’s discovery capabilities and our Th17 program, and enables us to expand the scope of our research in this promising area to expedite our discovery efforts as well as our timeline to enter the clinic.”

“Autoimmune diseases continue to represent a significant unmet medical need globally,” said Don Nicholson, Ph.D., vice president and head of worldwide discovery, Respiratory and Immunology Franchise, Merck Research Laboratories. “Lycera has established a strong reputation for innovation in this area and we look forward to working together to advance this program.”

Th17 cells are characterized by the production of interleukin-17 (IL-17), a highly inflammatory cytokine that plays an important role in immune-mediated diseases, including psoriasis, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease (colitis) and asthma. Lycera has developed a program that targets Th17 cells and has identified potent and specific inhibitors of RORγt that reduce IL-17 production in primary cells and in vivo.

Ricerca, Fulcrum Pharma in Pact

Posted on March 3, 2011 @ 09:19 am

Ricerca Biosciences has entered a strategic partnership with Fulcrum Pharma, an Aptiv Solutions company, to provide value-added capabilities to biopharma companies by creating a streamlined and efficient process to move a drug candidate from development to the clinic.

The collaboration will leverage Ricerca’s comprehensive preclinical services from early discovery medicinal chemistry, compound screening, profiling and lead optimization through full drug safety, metabolism and efficacy development support, as well as clinical supply and commercial API production. Fulcrum Pharma provides strategic and operational regulatory support to assist clients with regulatory submissions.

“The Fulcrum Pharma collaboration is an attractive and exciting proposition for Ricerca and our clients. Fulcrum Pharma brings deep experience in IND authorship and regulatory approval, which fits well with Ricerca’s preclinical services in discovery pharmacology, chemical development and drug safety assessment. The relationship greatly expands our ability to serve our clients who are preparing for regulatory submission anywhere in the world,” commented Ian Lennox, chief executive officer of Ricerca.

“The collaboration offers our early stage clients a streamlined service to move efficiently through preclinical development to creation of high quality IND submissions,” said Patrick K. Donnelly, Aptiv Solutions’ chairman and chief executive officer. “This approach, coupled with our expertise in adaptive clinical trial design, will provide our clients with the ability to accelerate the development of their products and stay ahead of the competition.”

LSNE Passes FDA Inspection

Posted on March 3, 2011 @ 09:15 am

LSNE has recently completed a comprehensive FDA audit of its medical device manufacturing facility in Manchester, NH. The successful completion of the week-long audit, for which no 483 citations were issued, demonstrated a quality cGMP manufacturing environment for services offered.

LSNE also recently completed an FDA Pre-Approval Inspection (PAI) and Compliance Audit for an Abbreviated New Drug Application (ANDA) for a sterile-injectable drug product at its Bedford, NH fill/finish facility.


Click here to learn more about LSNE
Amyris, Antibioticos Enter Contract Mfg. Pact

Posted on March 3, 2011 @ 09:11 am

Amyris, Inc. has entered into a contract manufacturing agreement with Antibióticos, S.A. to produce farnesene at Antibióticos’ facilities in León, Spain. The farnesene product will be owned and distributed by Amyris. The two companies began testing fermentation production runs in January 2011, and following the successful outcome, are proceeding with expanded production.

“This agreement with Antibióticos should allow us to reach our target initial production levels and meet customer demand for our near-term product offerings,” said John Melo, chief executive officer of Amyris. “We have been very impressed with the world-class technical expertise in aseptic fermentation at Antibióticos, and are looking forward to leverage this as we build up our commercial production capability.”

“This agreement merges our experience and technical capacity with Amyris’s technology and processes, and forms another important step in the strategy of diversifying our business portfolio,” said Daniele Pucci Di Benisichi, chief executive officer of Antibióticos. “Our initial work with Amyris has validated their technology in our facility. Additionally, we see a strong match between the two companies’ values and vision. Antibióticos follows a very demanding and selective approach for new projects, and we are proud to use this cutting-edge technology.”
Financial Reports: Kendle

Posted on March 3, 2011 @ 08:23 am

Kendle 4Q10

4Q Service Revenues: $77.9 million (-19%)

4Q Loss: $9.2 million (earnings of $5.0 million in 4Q09)

FY Service Revenues: $333.8 million (-20%)

FY Loss: $4.6 million (earnings of $15.2 million in FY09)

Comments: Early Stage service revenues dropped 38% in 4Q10 and fell 31% for FY. Late Stage service revenues declined 16% and 17% in those periods, respectively. The company took a $7.3 impairment charge in 4Q related to closing an facility in its Early Stage unit, and took a $3.8 million charge for restructuring costs.
Executive Moves: Quintiles

Posted on March 2, 2011 @ 09:30 am

Jim McDermott has been appointed managing director of Quintiles’ Market Intelligence Practice for the Consulting group. The group provides analytic tools and methodologies that combine techniques, decision modeling and analytics, to help guide biopharmaceutical companies through strategic planning.

“We are excited to have Jim join Consulting to lead this insight-driven team,”said Jay Norman, president of Quintiles Consulting. “Our consultants bring fresh thinking on market intelligence to help biopharma companies make better decisions throughout the entire product lifecycle. Developing a market-leading, profitable business strategy requires relevant, robust market intelligence – and consulting delivers.”

Mr. McDermott has more than 30 years of biopharma industry experience. For the past 10 years, he worked at Decision Resources, Inc., most recently as global practice leader of their consultancy group, where he was responsible for helping build the company’s applied syndicated data business for leading biopharmaceutical companies. Prior to DRI, he held positions at Index, SRI International, Nervewire and Procter & Gamble.
IRX Therapeutics Enters Research Collaboration


Posted on March 2, 2011 @ 09:26 am

IRX Therapeutics has signed a research collaboration agreement with a leading research-based pharmaceutical company to assess the potential effects of IRX-2 on the tumor microenvironment. Tumor specimens from subjects treated with IRX-2 and control subjects will be analyzed using gene analysis technology to characterize the action of IRX-2 immunotherapy at the molecular level.

IRX-2 is designed to broadly restore the immune system to overcome cancer–induced immune suppression and restore anti-tumor response. The IRX-2 immunomodulator includes multiple cytokine components that work to activate different arms of the immune system. IRX Therapeutics performed a Phase II trial that enrolled patients with newly diagnosed head and neck squamous cell cancer who received IRX-2 immunotherapy prior to surgery.

“This is a great opportunity for IRX Therapeutics to work with one of the leading developers of cancer therapies to further our understanding of the action of our novel immunomodulator, IRX-2. We are hopeful that these studies will further evidence the potential of IRX-2 to effect an immune based attack on a cancer patient’s tumor,” said John W. Hadden II, president and chief executive officer of IRX Therapeutics.

PTC Therapeutics Achieves BMI1 Milestone

Posted on March 2, 2011 @ 09:24 am

PTC Therapeutics, through its Wellcome Trust collaboration, has identified a chemical series of molecules that penetrates the blood-brain barrier in animal models and reduces levels of BMI1, a protein linked to drug-resistant cancers. The milestone triggers a $2.2 million payment to PTC.

The Wellcome Trust awarded PTC $5.4 million to support the development of drugs that target BMI1 back in June 2010. PTC identified the lead chemical series using its screening technique GEMS. The goal of the program is to identify a drug candidate for the treatment of chemotherapy-resistant cancers.

"We are pleased to reach this first milestone in our collaboration with the Wellcome Trust on schedule," said Stuart W. Peltz, Ph.D., president and chief executive officer of PTC Therapeutics. "We believe the therapeutic potential of a small-molecule inhibitor of BMI1 production is very significant. This milestone will support chemistry optimization efforts toward our next major goal of declaring a development candidate."
Celerion Adds USP 797-Compliant Clean Room

Posted on March 2, 2011 @ 09:21 am

Celerion has completed a clean room and pharmacist certification to comply with USP 797 guidelines. The certification allows in-house preparation for microtracer studies providing an alternative to the requirement for GMP manufacturing of the IV solution. The USP 797 clean room allows for complex extemporaneous compounding for low, medium and high-risk investigational compounds. This solution, combined with the company’s early stage adaptive trial designed studies, is designed to help clients reach clinical proof-of-concept faster.

The clean room design includes an ante-room that serves two individual clean rooms, one clean room is a dedicated microtracer area, which contains a Class A2 Biological Safety Cabinet for radiolabeled microtracer compounding, and an additional clean room contains a laminar flow hood for traditional IV compounding. Both clean rooms are ISO 7, attached to an ISO 8 ante-room and are used for sterile compounding.

“The addition of the USP 797 Clean Room continues to demonstrate Celerion’s commitment to implement innovative solutions to generate critical data to enable decisions in drug development to be made earlier,” said Phil Bach, vice president of Clinical Research at Celerion. “The clean room when combined with our Lincoln, Nebraska, facility’s radiolabel license, allows Celerion to offer execution of Phase 0, microtracer and microdosing studies producing data typically not available until later in drug development.”
Catalent Sells Printed Components Business

Posted on March 1, 2011 @ 09:40 am

Clondalkin Group has acquired the Printed Components business of Catalent Pharma Solutions. Terms of the transaction were not disclosed, and closing is subject to receipt of regulatory approval. The unit generated approximately $100 million in annual sales of secondary packaging products out of its four facilities in the U.S., Puerto Rico and Ireland.

Clondalkin and Catalent will enter into a long-term supply agreement which ensures that Catalent will continue to be able to provide services to its customers. Barry Russell, president of Catalent’s Medication Delivery Solutions business, said, “We are pleased that Clondalkin Group has agreed to acquire the business.We believe that Clondalkin will continue to build upon the business’ legacy of excellent service and high quality.We also believe the commitment Clondalkin Group has demonstrated to the industry aligns well with our approach of tailoring unique product supply solutions for our customers.”

Norbert McDermott, Clondalkin Group’s chief executive officer, said, “In the U.S., the acquisition further expands our leading position offering full-service dedicated pharmaceutical and healthcare production facilities at nine locations in NC, NJ, IN, CT and Puerto Rico. In Europe, combining Catalent’s cartons expertise with our inserts, leaflets and labels expertise presents excellent business development and cross-selling opportunities for our nine pharmaceutical and healthcare production facilities in Ireland, Spain, the UK and Poland.”

Headquartered in Amsterdam, Clondalkin has annual sales of more than $1.1 billion; after this acquisition, pharmaceutical and healthcare activities will account for approximately $340 million in annual revenues.


Click here to learn more about Catalent
Advion Signs Lilly Deal, Will Open Bioanalytical Lab

Posted on March 1, 2011 @ 09:38 am

Advion BioServices plans to open a 22,000-sq.-ft. drug discovery bioanalytical lab in the Purdue Research Park in Indianapolis. The lab is expected to be fully operational by the end of May 2011.

Advion’s primary focus is to provide high-quality, later stage bioanalytical drug development services as required by global regulatory agencies, including the FDA. The new Indianapolis facility will focus on the earlier stage, drug discovery bioanalytical services, evaluating how a potential drug is absorbed and metabolized in experimental models. Many of these services are data-generation activities required for clinical testing preparation.

Advion has also entered into a new, multi-year contract with Lilly to provide a variety of these services to be conducted at the new facility. As part of the agreement, Lilly will transition its drug discovery bioanalytical capability to Advion. All Lilly employees impacted will have the opportunity to join Advion. Financial terms were not disclosed.

“Drug discovery bioanalytical services in Indianapolis are a strategic complement to the regulated drug development bioanalytical services in our Ithaca, NY and Manassas, VA laboratories. Advion has always upheld the highest standards of scientific rigor and looks forward to establishing a center-of-excellence for discovery bioanalytical services in Indianapolis,” said Tom Kurz, president of Advion BioServices, Inc.
Daiichi Sankyo To Acquire Plexxikon

Posted on March 1, 2011 @ 09:38 am

Daiichi Sankyo Co. has entered an agreement to acquire Plexxikon, Inc. for $805 million up-front, with milestone payments associated with the approval of PLX4032 totaling an additional $130 million. The transaction is subject to customary closing conditions.

Plexxikon’s lead program is PLX4032 is an oral drug that targets the oncogenic BRAF mutation present in about half of melanoma cancers and about 8% of all solid tumors. Plexxikon and development partner, Roche, plan to file for market approval in the U.S. and Europe this year, along with a companion diagnostic. Following the acquisition, Daiichi Sankyo will retain the U.S. co-promotion rights for PLX4032.

“With the acquisition of Plexxikon, we see an opportunity to accelerate the building of our oncology franchise, particularly with the opportunity to co-promote PLX4032 as a very exciting personalized medicine,” said Joji Nakayama, chief executive officer of Daiichi Sankyo, Co. “Moreover, we have been impressed by the productivity and quality of Plexxikon’s pipeline, and discovery and early development capabilities. We intend to provide a high degree of independence to the Plexxikon group to support their continuing success.”

Plexxikon’s pipeline also includes additional products in development to treat cancer, including PLX3397 an oral, selective kinase inhibitor currently in Phase I development for Hodgkin lymphoma, AML, glioblastoma and metastatic breast cancer, and PLX5622, an oral agent entering Phase I for the treatment of rheumatoid arthritis.
Frontage Labs Gains AAALAC Certification

Posted on March 1, 2011 @ 09:37 am

Frontage Laboratories, Inc. has achieved AAALAC International accreditation. The Association for Assessment and Accreditation of Lab Animal Care evaluates organizations that use animals in research, teaching or testing to ensure and promote animal well being in science. Frontage, which provides preclinical DMPK, CMC drug development and CTM manufacturing, bioanalytical, clinical and consulting services, was assessed by the AAALAC evaluators regarding all aspects of animal care and use.

Dr. Abdul Mutlib, Frontage’s vice president of DMPK services, oversees the company’s animal facility. He has more than 20 years of drug metabolism research experience and is a thought leader in studies of Metabolites in Safety Toxicology (MIST), metabolite characterization, reactive metabolites, and metabolism-mediated toxicities. Jim Burleigh, lab manager, is the primary head for the animal facility. Mr. Burleigh has more than 25 years of experience in conducting ADME studies in lab animals.

Amatsi, Avogadro To Join Forces in Discovery

Posted on March 1, 2011 @ 09:34 am

Amatsi (formerly known as CRID Pharma) and Avogadro will join forces in an effort to provide a broader range of drug development services to their respective pharma and biopharma clients. Together, the companies will have more than 175 staff located in France and the U.S.

By combining their expertise and know-how, the group aims to provide its clients with an increased range of services including: Galenic development, analytical development, bioanalysis, PK-ADME studies, residues, etc., quality control (GLP/GMP), ICH stability studies, clinical supplies manufacturing (sterile/non sterile), packaging, storage and distribution, and regulatory support.

Jean-Pascal Conduzorgues, president of Amatsi, said, “With the support of Avogadro’s team, we can offer a larger range of facilities to our clients, increased development capabilities, as well as a stronger quality assurance framework. Together with André Weil, president of Avogadro and Jean-Pierre Arnaud, chief executive officer, I am very pleased to see our companies bringing together their strengths whilst still maintaining our common values of responsiveness, flexibility and customer service.”
Excella Gains Safebridge Certification

Posted on March 1, 2011 @ 09:32 am

Excella GmbH in Feucht, Germany has met the criteria established under the SafeBridge program for Potent Compound Safety Certification and has been deemed competent and proficient in the safe handling of potent APIs and potent drug products for the manufacture of oral solid dosage (OSD) forms. Excella is the first company worldwide to achieve SafeBridge Potent Compound Safety Certification for the manufacture of OSD forms.

SafeBridge conducted a 60-element review of health and safety programs, procedures, containment and exposure control of OSD operations with potent APIs at the company’s site and has certified that Excella meets current industry standards for the safe handling of potent APIs in the identified areas.

February 2011

Fujifilm To Acquire Merck Biomanufacturing Network

Posted on February 28, 2011 @ 10:03 am

Fujifilm Corp. and Merck have entered into a definitive agreement under which Fujifilm will acquire the Merck BioManufacturing Network, a provider of contract manufacturing and development services for the biopharma industry. Financial details were not disclosed but one report valued the transaction at approximately $489.4 million. The agreement is subject customary closing conditions.

Fujifilm will acquire the two subsidiaries that comprise Merck’s BioManufacturing Network, Diosynth RTP and MSD Biologics Ltd., which includes Diosynth’s facilities in Research Triangle Park, NC and MSD’s Billingham, UK site. The acquisition includes manufacturing contracts, business support operations, and respective workforces. As part of the agreement with Fujifilm, Merck/MSD has committed to certain continued development and manufacturing activities with these two companies.

“Fujifilm continues to build upon its ongoing commitment to delivering pharmaceutical business,” said Shigetaka Komori, president and chief executive officer of Fujifilm Corp. “This acquisition provides an important addition to our pharmaceutical business with diverse capabilities and technical expertise in production of protein therapeutics.”

“When Merck/MSD combined its biopharmaceutical manufacturing services businesses in the U.S. and UK into the Merck BioManufacturing Network, we established one of the world’s leading biopharmaceutical contract manufacturing organizations,” said Willie A. Deese, executive vice president and president, Merck Manufacturing Division. “With this transaction, Merck/MSD becomes a key customer that will continue to benefit from the expertise and experience of the combined businesses in biologics development and manufacturing.”

Almac Launches Schedule I-V Substance Capabilities

Posted on February 28, 2011 @ 10:01 am

Almac now provides packaging, storage and distribution of schedule I-V controlled substances at its North American Headquarters in Souderton, PA. The company has continued to grow its services and capacity following a $120 million investment initiative.

Storage of controlled materials is located in a highly secured temperature monitored cage and vault. Both locations meet DEA requirements and provide greater capacity with 3,980 sq. ft. of storage space.

Dave Setley, head of business development, said, “The expanded storage and distribution of controlled drug product from the NAHQ further solidifies Almac’s position as a leader in the clinical supply arena.”


Click here to learn more about Almac

Executive Moves: Kendle

Posted on February 28, 2011 @ 10:00 am

Martha R. Feller, Ph.D., has rejoined Kendle as vice president and global head, study start-up, effective immediately. In her new role, Dr. Feller will provide leadership for the company’s global study start-up function, including study start-up management, site identification, site start-up, clinical trial regulatory, investigator contracts and essential document collection. She will focus on fostering site relationships to optimize timelines and deliver rapid study start-up for global clinical trials.

Dr. Feller has more than 30 years of senior operations leadership in the clinical development industry, including broad therapeutic expertise and experience managing large-scale, global development programs. Dr. Feller recently served as executive vice president of global operations at i3 Research, where she was responsible for Phase I-III programs. From 2004 to 2009, Dr. Feller held leadership roles in Kendle’s Phase II-III development operations, serving most recently as senior vice president of global clinical development.

“Timely and efficient study start-up on global projects is essential to our business success and ability to deliver best-in-class clinical development solutions to our customers,” said Stephen Cutler, Ph.D., senior vice president and chief operating officer. “The appointment of an experienced industry veteran to lead this important function demonstrates our commitment to delivery of site selection and start-up strategies that provide valuable time-saving results for our customers.”
Pilgrim, QPharma Form Operational Alliance

Posted on February 28, 2011 @ 09:58 am

Pilgrim Software, Inc. and QPharma, Inc. have agreed to make QPharma’s set of validation, quality and regulatory compliance consulting services available to customers in collaboration with Pilgrim’s SmartSolve suite of products.

Pilgrim offers integrated risk, compliance and quality management solutions designed to help highly regulated organizations remain compliant, recognize and address potential operational dangers, reduce costs, and operate more effectively. Through the Pilgrim alliance, QPharma will leverage its Professional Services Business Unit for regulatory compliance spanning the product development lifecycle, from quality and validation solutions, to PDMA and fulfillment services.

“We are delighted to be working with Pilgrim Software,” said Ray Roggero, chief operating officer of QPharma. “It’s a natural fit with Pilgrim’s integrated risk, compliance and quality management solution, and by leveraging the natural synergies between Pilgrim and QPharma, organizations can gain an effective, practical roadmap for reaching their quality and regulatory compliance goals.”

QPharma’s offerings address a broad range of quality services from auditing, to documentation development, to enterprise-wide validation and compliance remediation programs. “Pilgrim and QPharma share a vision of executing successful software implementations, with knowledgeable consulting and support, that help organizations improve operational performance and ensure compliance with industry and regulatory standards,” said Prashanth Rajendran, chief operating officer for Pilgrim Software.


Click here to learn more about Pilgrim Software
Executive Moves: Absorption Systems

Posted on February 28, 2011 @ 09:56 am

Stacy L. Pritt, DVM, MS, MBA has been appointed director of preclinical laboratory operations, at Absorption Systems. Dr. Pritt will manage all lab facility operations related to the completion of non-GLP and GLP preclinical studies. She will be based at the company’s San Diego site.

Dr. Pritt has extensive experience overseeing regulatory compliance in a preclinical research setting. Prior to joining the company, she served as director and general manager of the Biological Test Center at B. Braun Medical, Inc., where she was responsible for developing, planning and managing preclinical testing programs for the pharmaceutical and medical device industries.

“Stacy has considerable experience managing preclinical study operations and we are excited to have her join the team,” said Patrick M. Dentinger, president and chief executive officer of Absorption Systems. “She has a proven track record of coordinating operational activities to ensure the successful, timely completion of preclinical studies.”

JHP Pharmaceuticals Enters Manufacturing Pact

Posted on February 25, 2011 @ 09:14 am

JHP Pharmaceuticals has entered into a multi‐year contract manufacturing agreement with an undisclosed biotechnology company. JHP will be responsible for the manufacture and supply of an approved therapy used to treat cancer.

Stuart Hinchen, president and co‐founder of JHP, said, “We recognize that being selected to produce this crucial drug demonstrates our ability to meet critical marketplace needs. JHP was able to achieve the rigorous timelines required to manufacture this drug through a quality‐driven, experienced staff and a customer‐centric approach. Additionally, our record of cGMP compliance, coupled with our experience in manufacturing site transfers, put us in the position to serve this important customer.”

Mr. Hinchen also noted, “This will be the second multi‐year contract JHP has entered during the last two months. These agreements are examples of how our approach to ongoing investment in our people and facilities allow us to focus on customer needs which results in rising, sustainable growth. Our Rochester, MI manufacturing site has a solid history of successful partnerships, manufacturing both clinical and commercial products.”


Click here to learn more about JHP Pharmaceuticals

SCM Pharma Expands

Posted on February 25, 2011 @ 09:11 am

SCM Pharma has expanded its potent capacity following an $810,000 investment at its UK-based facility. The expansion includes an additional dedicated suite to handle and fill highly potent products such as cytotoxics to cGMP, as well as a new 500-sq.-ft cleanroom dedicated to making potent products. Additionally, the company has developed a production technique to handle continuous throughput via isolators to boost its aseptic processing capacity.

Along with potent products, the company also provides sterile fill finish of C14 radio-labelled compounds to GMP standards, primarily to assist customers carrying out absorption, distribution, metabolism and excretion (ADME) studies at the pre-clinical or clinical trials stage.

Neal Wesley, technical director at SCM Pharma, said, “As the business has developed and grown over the past few years, we have always tried to adapt to our clients’ changing and increasing potent product manufacturing requirements. We have therefore invested heavily into modifying the facility to ensure we can efficiently deal with a range of different potent projects including small pilot scale, clinical trial progression and the market supply of niche licensed products.”
Samsung, Quintiles Form Bio-Manufacturing JV

Posted on February 25, 2011 @ 09:09 am

Samsung has formed a joint venture with Quintiles Transnational Corp., with $266 million of capital, in its first project in biopharmaceuticals. The three Samsung companies partnering with Quintiles, which includes Samsung Electronics Co., will own 90% of the venture and Quintiles will own 10%.

Initially, a factory will be built in Incheon, South Korea to produce biopharmaceutical drugs to treat cancer and arthritis on a contract manufacturing basis. Construction will begin during 1H11, with production expected to begin during 1H13. The company plans to develop a biosimilar of Rituxan, according to a Bloomberg report. Samsung also has plans to develop new biopharmaceuticals as part of its comprehensive 10-year investment plan.
Ipsen, Biomérieux Enter Personalized Medicine Pact

Posted on February 25, 2011 @ 08:59 am

Ipsen and bioMérieux have entered into a global collaboration around theranostics (personalized diagnostic medicine), with a focus on hormone-dependent cancers. The two companies will leverage their expertise and resources to develop a personalized approach to medicine based on Ipsen’s portfolio of compounds and bioMérieux’s diagnostic tests.

The companies will jointly identify programs for the co-development of a therapeutic and a companion diagnostic test, particularly in the prevention and treatment of prostate and breast cancers, neuro-endocrine tumors (NETs) and pituitary tumors.

“We are very pleased to build this partnership with Ipsen, which has developed over the years a significant scientific and medical expertise. Our goal is to reinforce personalized medicine and contribute through this partnership to the novel paradigm in medicine, which is increasingly “patient-driven” rather than “disease-driven”,” said Prof. Christian Bréchot, vice president of Institut Mérieux, in charge of medical and scientific affairs.
Thermo Fisher To Sell Lancaster Labs, Athena Diagnostics

Posted on February 24, 2011 @ 09:17 am

Thermo Fisher Scientific, Inc. has signed definitive agreements to sell its Lancaster Laboratories and Athena Diagnostics businesses for a total of $940 million in cash. Both transactions are expected to close in 2Q11.

Eurofins Scientific SE will acquire Lancaster Laboratories for $200 million, subject to a post-closing adjustment. Lancaster, based in Lancaster, PA, is a contract testing lab that provides analytical services for pharmaceutical, biopharmaceutical and environmental sciences customers. The business had approximately $115 million in revenues in 2010 and employs 1,100 at its operations in the U.S. and Ireland.

Quest Diagnostics, Inc. will acquire Athena Diagnostics for $740 million. Athena, based in Worcester, MA is a reference lab that provides diagnostic testing for neurological and other diseases, with an emphasis on gene-based tests. The business employs 300 and had approximately $110 million in revenues in 2010.

“Athena and Lancaster have performed very well within our company and we believe that these strategic buyers will offer them even greater opportunities for growth in the long term,” said Marc N. Casper, president and chief executive officer of Thermo Fisher Scientific. “The transactions position both businesses in companies that are closely aligned with the unique contract lab services they provide and, at the same, will generate significant proceeds that we can redeploy to create shareholder value.”
Carbogen Amcis To Restructure

Posted on February 24, 2011 @ 09:16 am

Carbogen Amcis AG will restructure its Switzerland operations in Bubendorf (BL), Aarau (AG) and Hunzenschwil (Neuland, AG), eliminating 60 positions as a result of inadequate profitability. The company currently has approximately 350 employees in Switzerland.

The restructuring efforts aim to allow the Aarau site to focus on development, and the Hunzenschwil (Neuland) site on the pilot production of early phase projects. Large-volume production and the manufacturing of highly active agents will continue at the Bubendorf site. The company plans to bolster the number of employees at the Hunzenschwil (Neuland) site to meet customer demand.

"During the transition we will direct our focus, as we would in any case, towards attending to customer demand and providing our customers with consistently high service," said Jay R. Vyas, managing director of the Dishman Group, owner of Carbogen Amcis AG. "The restructuring allows us to be prepared for the future as a sustainably successful organization. The restructured company will have potential for growth and the ability to adapt itself to a changing market situation."
Financial Report: ICON 4Q

Posted on February 24, 2011 @ 09:13 am

ICON 4Q

4Q Revenues: $232.1 million (+2%)

4Q Earnings: $22.1 million (-8%)

FY Revenues: $900.0 million (+1%)

FY Earnings: $87.1 million (-5%)

Comments: Operating income was $92 million for the year, representing 10.2% of revenue. This comprised clinical services operating income of $104.8 million or 12.5%, and central lab operating losses of $12.8 million. In the quarter, operating income was $22 million, representing 9.5% of revenue. Clinical services operating income accounted for $26 million or 12.1%, and a central lab operating loss of $4 million.

Prasco, Shire Enter Supply Pact

Posted on February 24, 2011 @ 09:12 am

Prasco Laboratories has signed a distribution and supply agreement with Shire US Manufacturing, Inc. for mesalamine controlled-release capsules. Pending FDA approval, Prasco is prepared to market the generic version of Pentasa (mesalamine) Controlled-Release Capsules, at Shire's request. The authorized generic will be marketed in the U.S. in 250 mg and 500 mg strengths under the Prasco label.

"We are excited to have established this new business relationship with Shire," said Prasco chief executive officer, E. Thomas Arington."Patients and pharmacists alike benefit when a company such as Shire commits to maintaining the supply of brand-identical medication through the Prasco Authorized Generic business model."
Executive Moves: Brecon Pharmaceuticals

Posted on February 24, 2011 @ 09:11 am

Kay O’Hagan has been appointed director of quality assurance and regulatory affairs at Brecon Pharmaceuticals. Ms O’Hagan will be responsible for Brecon’s QA and regulatory activities and will head the company’s team of Qualified Persons.

Ms O’Hagan joins the company from a major pharmaceutical company, where she was head of quality assurance in the UK. Ms. O’ Hagan is a microbiologist by training and has a wealth of knowledge and experience in R&D, production, quality control and quality assurance.

“We are pleased to welcome Kay on board,” said managing director Peter Belden. “Experience of the sort she is able to demonstrate is vital to the future growth of the company and we wish her every success in her new role.”
Elan, PPD Enter Global Development Pact

Posted on February 23, 2011 @ 09:19 am

Elan and PPD, Inc. have formed a global business collaboration focused on advancing the development of Elan’s portfolio. The goal of the alliance is to leverage both companies’ expertise in a flexible, integrated manner to expedite Elan’s clinical programs in a parallel way, on a global scale.

PPD will serve as Elan’s primary service provider for all development functions and activities. Elan will retain ownership of its assets and will be responsible for all decisions regarding strategy and progression of candidates, as well as the overall portfolio. Elan will leverage PPD’s capabilities across project and data management, biostatistics, regulatory, clinical and medical monitoring, quality assurance, pharmacovigilance and other areas. The two companies will work together to build upon this initial relationship and explore opportunities to maximize respective competencies in order to advance Elan’s portfolio. Financial terms and timelines were not disclosed.

“Establishing this strategic collaboration with PPD will enable Elan to accelerate the progression of our science into the clinical development setting in a rapid and global fashion,” said Eliseo Salinas, chief medical officer, executive vice president and head of development for Elan. “The ability to fluidly access additional expertise and execution capability on a global scale will complement our internal talent and may enable us to move multiple programs forward in a parallel manner.”

David Grange, chief executive officer of PPD, added, “PPD and Elan have established an innovative relationship structure that enables Elan to continue to invest in and advance its world-leading work in biology and its broad application in neuroscience, while leveraging PPD’s expertise and execution capabilities across key program areas on a global scale. This relationship brings together the strongest resources of both companies, and we are pleased to have created this unique and strategic business arrangement with Elan.”
Genzyme Selects Warnex for Central Lab Services

Posted on February 23, 2011 @ 09:16 am

Warnex Inc.’s Medical Laboratories division will serve as a central lab across Canada for Genzyme Canada Inc.’s Lysosomal Storage Disorders Testing Program. This program will assist physicians in diagnosing Fabry (male), Gaucher, Pompe and Mucopolysaccharidosis Type I (MPS I) diseases.

“We are pleased to collaborate with Genzyme to offer this program in Canada, assisting healthcare professionals in the diagnosis of these serious diseases. This collaboration demonstrates our ability to serve as a specialized reference laboratory for hospitals across Canada,” said Mark Busgang, president and chief executive officer of Warnex. “In the context of this program, Warnex will perform an enzymatic assay specific to each disease using dried blood spots. This method offers a simple type of sampling procedure that can be easily performed by pricking the finger and applying drops of blood to a blotting paper.”

“While early diagnosis of these rare diseases is critical, it can be challenging for several reasons. Signs and symptoms of many LSDs often mimic those of other more common diseases and outward characteristics may be subtle and easily overlooked,” said Monty Keast, director of personalized genetic health at Genzyme Canada. “This program aims to facilitate early diagnosis by making blood spot testing available for physicians to use with patients who have symptoms associated with LSDs.”
Covance, Ingenuity Enter NGS Data Pact

Posted on February 23, 2011 @ 09:15 am

Ingenuity Systems has entered a research collaboration with Covance Genomics Laboratory for next-generation sequencing (NGS) data analysis. The two companies will work together to develop new approaches, using Ingenuity’s IPA software, to obtain more actionable insights from NGS data.

With the generation of new biological interpretation tools, Covance Genomics Lab aims to help pharmaceutical clients maximize the value of their investment in NGS technologies, according to a Covance statement. IPA is designed to help mitigate the NGS data analysis bottleneck by providing the biological context necessary to move past the long lists of genes, isoforms, and variants, to help uncover those that are most critical to biology. This enables researchers to quickly get to the intended high-value results of biomarker identification, target ID and validation, understanding drug mechanism of action, and safety assessment.

“We’re delighted that Covance has selected IPA for its NGS workflows,” said Doug Bassett, Ph.D., chief scientific officer and chief technology officer, Ingenuity Systems. “We’ve been involved in several NGS collaborations recently, and our partnership with Covance represents another powerful validation of IPA’s value in the NGS space. “

“The complexity of next-generation sequencing data can be a challenge to translational science and medicine,” said Tom Turi, vice president, Science & Technology, Covance Discovery & Translational Services. “We’re confident the combination of our best-in-class genomics data and the high-quality biological content and context provided by IPA will result in the delivery of more rapid, accurate, and thorough research services for our customers.”
Quintiles Central Lab Gains CAP Accreditation

Posted on February 23, 2011 @ 09:13 am

Quintiles‘ lab in Marietta, GA has received accreditation from the College of American Pathologists (CAP) 15189SM Accreditation Program. The Quintiles lab meets the rigorous requirements for medical lab quality and competence established by the International Organization for Standardization (ISO).

“Quintiles has an unwavering commitment to deliver high quality, globally harmonized test results that help our biopharma customers drive decision-making in the New Health,” said Thomas Wollman, senior vice president, Quintiles Global Central Laboratories. “Quintiles has the largest CAP-accredited central laboratory network in the world, and the CAP 15189 Accreditation Program is a natural extension of our quality program. Our goal is to have every lab in our network accredited to this international quality standard.”

With CAP 15189 accreditation, Quintiles has achieved a best practices standard in lab-related quality management systems. CAP 15189 is a voluntary, non-regulatory accreditation to the ISO 15189:2007 Standard, which utilizes specific criteria, procedures and processes to determine lab technical competence. The accreditation program aims to optimize processes, strengthen quality standards, reduce institutional errors and risks and control costs.

Gilead To Acquire Calistoga

Posted on February 22, 2011 @ 09:24 am

Gilead Sciences will acquire Calistoga Pharmaceuticals for $375 million, plus an additional $225 million if certain milestones are achieved. The transaction is expected to close in 2Q11.

Calistoga is a privately held biotechnology company focused on developing therapies to treat cancer and inflammatory diseases. Calistoga’s portfolio includes compounds that selectively target isoforms of phosphoinositide-3 kinase (PI3K), a central signaling pathway related to cellular proliferation, survival and trafficking. The company’s lead product candidate, CAL-101, is currently in Phase II studies in patients with refractory indolent non-Hodgkin’s lymphoma (iNHL) and in combination with rituximab in treatment-naïve elderly patients with chronic lymphocytic leukemia (CLL). Calistoga’s development pipeline includes other selective PI3K inhibitors that are in preclinical development for the potential treatment of both cancer and inflammatory diseases.

“Oncology remains an area of significant unmet medical need and our increased understanding of the genetic basis of cancer allows for the development of disease specific targeted therapies. We are very encouraged by emerging clinical data for CAL-101, and this compound could represent an advance for the treatment of certain hematological cancers,” said Norbert W. Bischofberger, Ph.D., Gilead’s executive vice president, R&D and chief scientific officer. “Building on the recent acquisitions of CGI Pharmaceuticals and Arresto Biosciences, this acquisition serves to further broaden Gilead’s pipeline and expertise in the areas of oncology and inflammation.”
Sheffield, Wockhardt Enter Insulin Supply Pact

Posted on February 22, 2011 @ 09:21 am

Sheffield Bio-Science and Wockhardt Ltd. have formed a global sales, marketing and development alliance under which Sheffield will be the exclusive global sales and distribution partner for recombinant insulin manufactured by Wockhardt. Wockhardt was one of the first companies to have developed, manufactured and marketed Wosulin, recombinant insulin injectables. The company’s biotech park in Aurangabad, India has six dedicated manufacturing facilities.

Dr. Habil Khorakiwala, chairman of Wockhardt Group, said, “This partnership is a reaffirmation of Wockhardt’s biotechnology research prowess and a confluence of innovative novel technology now being offered to global cell culture markets.”

Sheffield’s director of global business development, Hans Huttinga, stated, “We are looking forward to developing a strong and lasting partnership between our organizations.”
MorphoSys Earns Novartis Milestone

Posted on February 22, 2011 @ 09:20 am

MorphoSys AG has received a milestone payment from Novartis for the installation of its HuCAL antibody platform at Novartis Institutes for BioMedical Research in Basel, Switzerland. The milestone is related to an agreement between the two companies for Novartis to internalize the HuCAL technology.

“We are delighted to have reached this important milestone with Novartis just three years after the signature of our strategic alliance,” said Dr. Simon Moroney, chief executive officer of MorphoSys AG. “The payment is of major financial benefit to MorphoSys. Furthermore, this news underscores Novartis’s commitment to HuCAL and the ongoing success of our collaboration based on this technology.”

In December 2007, the two companies entered a comprehensive strategic alliance for the discovery and development of biopharmaceuticals. The ten-year agreement is potentially worth $1 billion and covers the use of MorphoSys’s HuCAL technology to generate therapeutic antibody products. MorphoSys receives technology license fees, R&D funding, and product-related milestones and royalties.
Omeros Expands License of PDE7 Inhibitors

Posted on February 22, 2011 @ 09:18 am

Omeros Corp. has expanded its exclusive license of phosphodiesterase 7 (PDE7) inhibitors from Daiichi Sankyo Co., Ltd. to include addiction and compulsive disorders. Omeros believes that PDE7 inhibitors could be effective therapeutics for the treatment of movement disorders, such as Parkinson’s disease, as well as addiction and compulsive disorders.

Omeros has shown in animal models of cocaine addiction that PDE7 inhibitors reduce cocaine self-administration, inhibit relapse induced by cues and stress, and facilitate drug abstinence in previously addicted animals.

“We are pleased to announce our agreement with Daiichi Sankyo and the additional therapeutic focus of our PDE7 program,” said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “From the advanced Daiichi compounds we have already selected a clinical candidate, and we expect that addiction will provide us with a faster and less expensive development pathway for our PDE7 program. We are collaborating with NIDA on additional studies that will evaluate our compounds in addiction, and we look forward to working with NIDA to advance this program through the clinic.”
BioStorage Joins AMDeC’s Vendor Partnership Program

Posted on February 18, 2011 @ 08:47 am

BioStorage Technologies has joined AMDeC’s Vendor Partnership Program that provides members with preferred pricing on various products and services for medical research. BioStorage will provide biomaterial storage and relocation services. AMDeC comprises 22 academic medical research institutions in the New York region.

According to Maria Mitchell, Ph.D., president of AMDeC, "By offering our members discounted access to services provided by BioStorage Technologies, AMDeC is helping to significantly reduce monthly expenditures and investments in capital equipment and facilities that can rapidly escalate operating costs."

Lori Ball, chief operating officer of BioStorage Technologies, said, "BioStorage Technologies recognizes the critical importance of ensuring secure, reliable, traceable access to biological specimens stored to support research advancements. The same expertise and care we use in managing millions of samples for pharmaceutical and biotechnology companies will be applied to create sample management solutions for AMDeC Members in the academic research setting."

As part of its services, BioStorage will conduct on-site audits of AMDeC Member institutions to assess their needs and create a customized sample management strategy through outsourced or on-site solutions. AMDeC members will also have access to BioStorage Technologies' web-based tracking and sample management system, ISISS (Intelligent Specimen Inventory Storage System). This system allows users to monitor sample status and activity, view audit trails and documentation, schedule shipments, and retrieve data on stored samples.
Executive Moves: Metrics

Posted on February 18, 2011 @ 08:44 am

Reneé L. Smith has been appointed to the newly created validation manager position at Metrics, Inc. Ms. Smith has 10 years of validation management experience with expertise in master site plan protocols for equipment, facilities, utilities and operations. Most recently, she served as senior validation associate for a large commercial manufacturing operation.

“Validation is how a respected contract pharmaceutical development and manufacturing company like Metrics proves to clients that our work will consistently meets their requirements,” said Tom Wilson, vice president of quality operations. “Validation is something Metrics has done well since our start. Because of our sizeable growth in recent years, we felt it was time to consolidate our internal validation activities and designate one point-person to be accountable for it.”


Click here to learn more about Metrics

Executive Moves: Ockham

Posted on February 18, 2011 @ 08:41 am

Michael Enright has been appointed president of OckhamCRO, effective immediately. Mr. Enright will provide senior-level leadership and perspective to pharmaceutical, biotechnology and medical device clients for the company’s Phase I-IV clinical operations globally. He will also be responsible for driving overall corporate performance with a customer-centric focus.

He has more than 15 years of experience in financial project management and surveying of the biotechnology and pharmaceutical markets. Previously, Mr. Enright served as Ockham’s chief financial officer, where he successfully helped navigate the merger between Atlantic Search Group and Ockham Development Group.

Ockham’s chief executive officer, James Baker said, “Ockham is very excited to have an experienced, well-rounded leader to assume the OckhamCRO leadership role. With Mike leading the CRO, we are one step closer to achieving our goal to be the number one, global oncology CRO in the next few years.”
Alphora Expands Operations

Posted on February 18, 2011 @ 08:37 am

Alphora will expand its facilities and capabilities for API technology development across all areas, with a focus on R&D, cGMP operations, and analytical services. The company also plans to bring the number of employees to more than 90.

Alphora recently secured new research facilities, allowing a 50% increase in its process chemistry R&D capacity. Isolation technology is being added to support high potency compounds, and three separate isolators will be added for developing high potency API’s. Additional analytical equipment will include a GC/MS system for API characterization and control of Genotoxic Impurities (GTI’s). Also, a fourth cGMP Kilo Lab will be constructed, equipped with a 60L Buchi glass lined cryogenic vessel and supporting equipment. The kilo lab will have a dedicated HEPA filtered heating and ventilation system and pressure locks for class 100,000 use.

The company is also expanding warehouse capacity with new storage facilities for API’s, intermediates, raw materials and solvents, and a new Enterprise Resource Planning (ERP) system will be installed to provide greater control and flexibility to its plant operations.
Almac Launches Bioinformatics Consultancy

Posted on February 17, 2011 @ 09:32 am

Almac’s Diagnostics business unit has launched its Bioinformatics Consultancy service to support discovery and development of biomarkers. The consultancy aims to promote an understanding of biology by partnering with customers from the initial study design through to the interpretation of data.

The consultancy service offers customizable bioinformatics and biostatistics solutions that include biomarker discovery and development, exploratory analysis, mechanistic and functional analysis, traditional and next generation sequencing data analysis, biostatistics and data integration.

Professor Paul Harkin, president and managing director of Almac’s Diagnostic business unit, said, “Bioinformatics has always been a key strength for us in Almac. Over the years we have built up a world-class team of bioinformaticians and biostatisticians. This team has provided invaluable support for both our internal research and our external work. The launch of the full bioinformatics consultancy business is the next logical step in enabling our customer’s to access this important resource.”


Click here to learn more about Almac

Glatt Adds cGMP Manufacturing Capacity at NJ Facility

Posted on February 17, 2011 @ 09:30 am

Glatt Pharmaceutical Services has added new commercial scale cGMP contract manufacturing capacity at its 86,000-sq.-ft. facility in NJ for tablet and capsule production. Added production capabilities include: high shear wet and fluid bed granulating/drying, tablet compression and pan coating, Wurster HS pelletizing and coating, CPS technology direct pelletizing, oven tray drying/curing, blending, milling, sieving and QC. Additional capabilities include organic solvent or aqueous and DEA controlled substance (CII – CV).

“We've made this investment in commercial scale operations in order to provide our clients the speed-to-market and high quality standards demanded in today’s competitive market,” said Oliver Mueller, executive vice president business development, Glatt Pharmaceutical Services.
Executive Moves: DPT Laboratories

Posted on February 17, 2011 @ 09:28 am

Luis Velez has been named director of development services at DPT Laboratories. Mr. Velez will lead the project management team and focus on implementing management programs such as LEAN and Process Excellence.

“Luis has a strong track record of project management success, and a grasp of advanced business management concepts that will further strengthen our leadership among contract development and manufacturing organizations,” said Lyle Flom, DPT vice president of Development & Commercial Services.

Mr. Velez has 15 years of pharmaceutical industry experience. Previously he served as new products transfer director with Cordis USA, based primarily in Ciudad Juarez, Mexico. In this position, he led all new products and processes transfers for the company, including pilot lines operations in Mexico, California and Ireland.

Click here to learn more about DPT
Executive Moves: PharmaNet Development Group

Posted on February 17, 2011 @ 09:26 am

Jeffrey Freitag, M.D., senior vice president, PharmaNet Consulting, will also become chief medical officer of PharmaNet Development Group, Inc. Dr. Freitag will be the senior medical representative for the company and provide guidance to physicians involved in designing and monitoring Phase I - Phase III trials. He will also continue to head PharmaNet's team of regulatory and pharmaceutical consultants.

"Excellence in pharmaceutical science and medicine is critical to the success of PharmaNet and its clients. We are therefore very pleased that Dr. Jeffrey Freitag, an accomplished internist and nephrologist, will be serving in the role of CMO," said Dr. Tom Newman, president of PharmaNet Development Group.

Dr. Freitag has worked in the pharmaceutical industry for more than 25 years in a variety of positions including vice president, clinical drug development at The Liposome Co., senior vice president of Medical Affairs at PharmaNet and most recently as vice president of R&D at Bone Care International before rejoining PharmaNet in 2006.
Executive Moves: Richman Chemical

Posted on February 17, 2011 @ 09:17 am

Christopher Kulp has been named vice president of Richman Chemical, Inc. Mr. Kulp has guided business development and project management efforts for the company over the past 10 years. Most recently, he served as director of RCI’s Contract Services Business, where he spearheaded a significant growth period for the company despite the recent economic challenges.

Mr. Kulp will assume increased responsibilities geared toward forming relationships with the greater venture capital and technology transfer communities, identifying investment opportunities within relevant industries and technologies, and planning overall corporate strategies. He will also oversee RCI’s recent entrance into the complementary contract bioprocessing market.

Mr. Kulp began his career at Richman Chemical in 1998 as a project manager within the Custom Manufacturing Division. In 2001 he was promoted to manager of new business development, and in 2007 he served as the company’s director of contract services.

Sanofi To Acquire Genzyme for $20 Billion

Posted on February 16, 2011 @ 09:15 am

Sanofi-Aventis and Genzyme Corp. have reached a definitive agreement under which Sanofi will acquire Genzyme for approximately $20.1 billion in cash. Genzyme shareholders are also eligible to receive additional milestone payments related to Lemtrada (alemtuzumab MS), or a milestone related to 2011 production volumes for Cerezyme and Fabrazyme. The transaction is expected to close early in 2Q11, subject to customary closing conditions.

“This agreement with Genzyme is both consistent with our long-term strategy and creates significant long-term value for our shareholders,” said Christopher A. Viehbacher, chief executive officer of Sanofi-Aventis. “This transaction will create a meaningful new growth platform for SA while expanding our footprint in biotechnology. We expect it to be accretive from year one, and the contingent value rights (CVR) structure, which served as an important value bridge between our two companies, rewards both Genzyme and Sanofi-aventis shareholders, particularly if Lemtrada outperforms the market’s current expectations.”

Financial Reports: Genzyme

Posted on February 16, 2011 @ 09:13 am

Genzyme

4Q Revenues: $1.2 billion (+23%)

4Q Earnings: $471.9 million (earnings were $23.2 million 4Q10)

FY Revenues:
$4.0 billion (+2%)

FY Earnings: $422.1 million (flat)

Comments: During the quarter, the company ceased fill/finish operations at its Allston facility for products sold in the U.S. According to the company, the recovery of Cerezyme supply is on track, and Fabrazyme supply is improving with allocations up 82% from the third to fourth quarter. Cerezyme sales in the quarter were up 111% to $222.0 million. Fabrazyme sales were up 6% to $61.6 million. Myozyme sales were up 39% to $127.5 million. For the year Cerezyme sales were down 9% and Fabrazyme were down 56%. Myozyme sales for the year were up 27%.

Daiichi Sankyo Acquires Amcor Facility

Posted on February 16, 2011 @ 09:10 am

Daiichi Sankyo, Inc. (DSI) has acquired a 140,000 sq.-ft. facility in Bethlehem, PA from Amcor, in a transaction valued at $10.3 million. The manufacturing and packaging facility allows DSI to use existing resources to more cost-effectively supplement its operations rather than build a new facility. Expected to be operational in the summer or fall of 2011, the facility is expected to package some of company’s marketed products, such as Benicar, Welchol and Azor. Once the facility is operating at full capacity, it is expected to assume responsibility for packaging the entire line of marketed products in the U.S., as well as perform compounding operations for select products.

DSI conducted a national site search with McCallum Sweeney Consulting to find an existing facility that met its packaging goals and specifications. Upon completing the initial phase of the renovation, DSI plans to hire approximately 80 new employees.

“This acquisition diversifies our company’s capabilities and allows us to streamline our operations and minimize commercialization risk by exerting greater control over the life cycle of our products, from research and development through packaging and distribution,” said Jeff Lane, vice president of operations, Daiichi Sankyo. “We are excited to be opening a facility in Bethlehem and look forward to a productive future working relationship and becoming a part of the local community.”
NSF Acquires Pharmalytica Services

Posted on February 16, 2011 @ 09:08 am

NSF International has acquired Pharmalytica Services, a pharmaceutical contract lab based in Connecticut. Pharmalytica provides a full range of GLP and GMP analytical services to the pharmaceutical and biotechnology industry from discovery support through commercialization, at its FDA-registered and DEA-licensed facility. Pharmalytica specializes in extractables and leachables testing, method development and validation, and bioanalysis.

NSF’s Health Sciences Division currently offers certification, training, consulting and GMP auditing for pharmaceuticals, dietary supplements and medical devices. As part of NSF’s Health Science Division, NSF Pharmalytica will provide analytical testing, consulting, training, registration, and R&D services. NSF Pharmalytica will operate primarily as a GLP & GMP contract lab, offering a wider array of independent testing and analytical services.

“Combining Pharmalytica’s knowledge in pharmaceutical analytical testing and R&D with our existing portfolio of dietary supplement and pharma solutions will help pharmaceutical companies worldwide make informed decisions when developing new products and strategies,” said Kevan P. Lawlor, NSF International’s chief executive officer and president.

“We have great confidence that Pharmalytica’s expertise, in synergy with NSF’s 65 years of testing and certification expertise, will be of great benefit in the development of new medicines worldwide,” said Dr. James Scull, executive director of Pharmalytica Services. Dr. Scull is a member of Contract Pharma’s Editorial Advisory Board.

Creapharm, BioConvergence Bridge Services

Posted on February 16, 2011 @ 09:06 am

BioConvergence and Creapharm have partnered in an effort to provide customers with lower costs, reduced risks, and increased control of projects. The partnership — called the “Transatlantic Bridge” — aims to combine pharmaceutical services and provide integrated, customized services with innovative, transparent, and effective solutions, without adding the resources and costs associated with managing multiple partners.

The “Transatlantic Bridge” provides access to North America from Europe and Europe from North America through a single point of contact that manages all aspects of the project including contract management, project management, product development, production, testing, and clinical supply services. The companies manage critical path initiatives using their collective geographic presence and regulatory knowledge. Clients will acquire project information using E-Transparency System, a secure portal providing real-time access to development, production, supply chain and quality data.

“I’m pleased to announce that through our collaboration with Creapharm, we will deliver new sourcing, contracting, and management options designed to optimize early clinical development, production, testing, and supply chain design and execution. By doing so, our clients will realize results they value,” Alisa Wright, chief executive officer, BioConvergence LLC.

“Creapharm is one of the leaders in Europe for pharmaceutical development and clinical supplies, but until now has had no operations in North America, which is and will remain the number one territory for clinical studies. Through our collaboration with BioConvergence I am pleased to announce that we can now provide to our European clients a “Transatlantic Bridge,” a seamless extended supply service of the highest quality for clinical studies in North America,” said Michel Pautrat, chief executive officer, Creapharm Europe.
BASi Expands Discovery Services

Posted on February 16, 2011 @ 09:04 am

BASi (Bioanalytical Systems, Inc.) has added the ability to work with large animals through its Culex Automated In Vivo Discovery Services. According to the company, the process offers extensive, faster and more meaningful results to help develop new drugs, while easing the stress on animals. Additionally, the company has added non-clinical scientist Brad Gien to its Culex services team.

The Culex Automated In Vivo Sampling Services offer investigators a way to increase the amount and type of data gathered in drug discovery experiments with small and now large animal models. By offering both, clients will have a broader range of options in study design. Additionally, Culex allows programmed sampling of blood and other body fluids without human intervention, at any time, or continuously for 24 hours or more. This approach reduces animal usage and helps to provide stronger data.

“One major benefit of automated sampling is reduced stress in the subject,” said Craig Bruntlett, senior vice president of instrumentation. “Stress can create a significant impact on the physiological parameters and can make data difficult to interpret. Reducing stress for the animal can lead to cleaner, more meaningful data.”

Mr. Gien joins the company with 10 years of experience in biomedical research, extensive rodent surgery capability and familiarity with the automated Culex system. “His experience and surgical skills will expand the capability of the BASi PK/PD laboratory in Mt. Vernon, IN,” said director of toxicology, David Hopper.


Click here to learn more about BASi
Ricerca Sells Bothell Site to Numira

Posted on February 15, 2011 @ 10:10 am

Ricerca Biosciences has sold its Bothell (West), WA in vivo operation to Numira Biosciences, a CRO specializing in high-resolution imaging and analysis of small animal specimens. Numira assumes responsibility of the Bothell site along with 21 former Ricerca employees.

Michael Beeuwsaert, president and chief executive officer, Numira Biosciences, remarked, “Ricerca’s Bothell (West) facility represented a good fit for the direction that we want to take Numira. The operations and scientific team attracted our attention and merge well with our current capabilities.”

“Ricerca’s high client service satisfaction delivered by great scientists has earned it an enviable reputation in the industry. We are pleased that this transaction will serve our clients and our employees well,” said Ian Lennox, chairman and chief executive officer, Ricerca Biosciences.
Takeda, Covance and Quintiles Enter Strategic Pact

Posted on February 15, 2011 @ 09:53 am

Takeda’s Pharmaceutical Development Division has entered into strategic partnerships with Covance and Quintiles to plan and execute global development programs to support new compounds in all therapeutic areas, except oncology.

Takeda will have access to Covance and Quintiles clinical development capabilities and central lab services, with each partner providing resources to support Takeda’s development pipeline. Takeda plans to use a global program-level sourcing strategy to increase operational efficiency. Through these relationships, Takeda will take on a fully virtual outsourcing model combining the expertise of all parties to help improve productivity and facilitate its global growth.

“Takeda is focused on growing its global drug development footprint, especially in Asia, while at the same time ensuring quality and increasing efficiency of our operations,” said Robert Ahlbrandt, Ph.D., senior vice president, global development operations for Takeda’s Pharmaceutical Development Division. “Our new strategic partnerships with Covance and Quintiles will improve the agility and productivity of our drug development activities, helping us to deliver innovative new medicines to patients globally.”
Catalent Acquires Lyopan Technology

Posted on February 15, 2011 @ 09:48 am

Catalent Pharma Solutions has entered into a license agreement with Pantec AG for the exclusive worldwide development rights to the Lyopan fast-dissolve technology for healthcare products. The acquisition provides Catalent with new oral dose capabilities, potentially enabling the delivery of improved, compliance-enhancing treatments across a broad range of applications, including central nervous system drugs, allergy medications, and dosage forms for pediatric and geriatric populations, as well as prescription and OTC products.

“We are pleased to add the Lyopan technology to Catalent’s oral dose technology offering, which will enable us to provide our pharmaceutical partners with an enhanced choice of drug delivery technologies to improve the performance of their treatments,” said Ian Muir, Ph.D., president, Modified Release Technologies for Catalent. “The Lyopan technology is ideally suited to deliver a wide dose range of active pharmaceutical ingredients in a fast-dissolve tablet. These are key considerations for situations where patient adherence, ease of swallowing and lack of access to water are important issues to address.”

Lyopan is a technology for development and manufacture of fast-dissolve lyophilized tablets. Lyopan requires significantly less water than existing technology, reducing energy consumption, sublimation and drying time. The technology also offers the potential for improved taste-masking capabilities and may increase the range of drugs and consumer products that can be used in a fast dissolve dosage form.
Executive Moves: Kendle

Posted on February 15, 2011 @ 09:46 am

Candace Kendle, Pharm.D., will step down from her role as Kendle’s chief executive officer, effective May 1. She will remain chairman of the board. Senior vice president and chief operating officer Stephen Cutler, Ph.D., will become the company’s next president and chief executive officer. Jamie Macdonald will assume Dr. Cutler’s previous roles.

Christopher Bergen
will leave his position as executive vice president and chief administrative officer but will continue to serve on the Kendle’s board. The CAO role, held by Mr. Bergen since July 2009 to lead the company’s key global connectivity initiatives, including ERP, will be eliminated as these initiatives are in advanced stages of implementation. Dr. Kendle and Mr. Bergen co-founded Kendle in 1981.

“We would like to thank our leadership team and the many talented associates across the globe with whom we have had the privilege to work in making Kendle the leading CRO it is today,” said Dr. Kendle. “With the company solidly positioned for growth in a strengthening market and an outstanding successor and executive team in place, now is the right time for me to step into the role of a non-executive chairman.”

Dr. Kendle continued, “Steve Cutler is ideally suited to lead Kendle moving forward. With more than 20 years of senior management and operations leadership experience in the CRO and biopharmaceutical industries, he has a strong track record of success in building outstanding teams, executing winning strategies and driving operational and service excellence. Since 2009, Steve has been central to Kendle’s leadership during a critical period in our history and has been a key architect of our return-to-growth strategy. I have enjoyed working with him and the board as part of the planned succession process and look forward to working together to ensure a smooth and orderly transition.”

Dr. Cutler joined Kendle in 2009 as senior vice president and chief operating officer and since that time has provided global leadership for the company’s worldwide Late Stage operations. Prior to Kendle, Dr. Cutler spent 14 years with Quintiles where he served in a variety of senior vice president roles. Prior to joining Quintiles Dr. Cutler held positions with Sandoz in Australia and Europe.

Jamie Macdonald will join Kendle May 1 following 16 years with Quintiles where he served most recently as senior vice president and head of Global Project Management with direct responsibility for more than 1,000 associates and delivery of approximately $2 billion in annual service revenue. While at Quintiles Mr. Macdonald held a number of executive-level roles.
Lilly’s Mirror Portfolio Marks Milestone

Posted on February 15, 2011 @ 09:30 am

A venture capital firm involved in Lilly’s Mirror Portfolio, a concept created by Lilly to access innovation developed outside the company, has acquired two molecules and will oversee further development. The first is a molecule developed at a major academic institution that is being studied as a potential treatment for congestive heart failure. The second molecule, developed by Lilly, is being studied for its potential in bone healing and cancer. Chorus, Lilly’s virtual development organization, will conduct the studies for the two molecules at the companies’ direction.

Through the Mirror Portfolio, virtual companies financed by independent investment funds will acquire molecules, manage financing, determine manner of execution, and particular organization, that will conduct the research for early-stage molecules to clinical proof-of-concept, at which point they will be sold.

“The licensing of these molecules by the independent funds is an important milestone for the Mirror Portfolio. Working with venture capital to make the concept of the Mirror Portfolio a reality is one way Lilly is ‘innovating on innovation’ as we strive to support the development of new medicines for the benefit of patients around the world,” said Robert W. Armstrong, vice president, global external R&D, Lilly. “Another benefit of the Mirror Portfolio is that it provides access to capital, capacity, capability and deep disease expertise that can be focused on developing molecules generated in research institutions or biotechnology companies, with the potential for rights to successful molecules to be purchased by Lilly.”
Lucentis Meets Phase III Endpoint in DME

Posted on February 14, 2011 @ 09:59 am

Genentech’s Phase III study evaluating monthly Lucentis (ranibizumab injection) in patients with diabetic macular edema (DME), met its primary endpoint. DME is a serious complication of diabetes that can lead to blurred vision, severe vision loss and blindness. The RISE study showed that a significantly higher percentage of patients receiving monthly Lucentis achieved an improvement in vision of at least 15 letters on the eye chart at 24 months, compared to placebo. A preliminary analysis of the data did not reveal any unexpected safety signals.

“DME is a leading cause of blindness among working-aged adults in most developed countries, and currently there are no FDA-approved medicines to treat patients who suffer from this debilitating condition,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “We are encouraged by these data and await the results of RIDE, our other pivotal study in DME.”

Lucentis was recently approved for treatment of visual impairment due to DME in Europe, where it is marketed by Novartis. In the U.S., Lucentis was approved for treatment of neovascular (wet) age-related macular degeneration (AMD) in 2006 and more recently for treatment of macular edema following retinal vein occlusion (RVO) in June 2010. RISE and RIDE are two identical, parallel confirmatory studies designed to support the application to the FDA for Lucentis in DME.

BrainStorm’s NurOwn Gets Orphan Status

Posted on February 14, 2011 @ 09:57 am

BrainStorm Cell Therapeutics, Inc. has been granted orphan drug designation for its NurOwn autologous adult stem cell candidate for the treatment of amyotrophic lateral sclerosis (ALS), referred to as Lou Gehrig's Disease.


“We are extremely pleased to have been granted the benefits of orphan drug designation as we continue to advance NurOwn as a potential new treatment for ALS, for which we expect to begin human clinical trials during the first half of 2011,” said Chaim Lebovits, president of BrainStorm. “Because of the safety profile with autologous adult stem cells, potential for intramuscular or intrathecal administration, and multiple mechanisms of action, we feel this product candidate could help effectively address the needs of patients with ALS and other neurological disorders.”

Orphan Drug designation is granted for new drug therapies that treat diseases affecting fewer than 200,000 people in the U.S. and entitles BrainStorm to seven years of marketing exclusivity for NurOwn upon regulatory approval, as well as the opportunity to apply for funding from the U.S. government.

BioSante’s LibiGel Shows Positive Safety Profile

Posted on February 14, 2011 @ 09:55 am

BioSante Pharmaceuticals, Inc. achieved positive safety data in its Phase III program for LibiGel (testosterone gel) in development for the treatment of female sexual dysfunction (FSD) and hypoactive sexual desire disorder (HSDD) in menopausal women. In the study with 2,869 women enrolled and more than 3,000 women with years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study, there were 17 adjudicated cardiovascular (CV) events, with a lower than anticipated rate of approximately 0.57%. Eight breast cancers were reported, a rate of approximately 0.27%.

Following its fifth review of all safety data by an independent Data Monitoring Committee (DMC), the Phase III LibiGel safety study will continue per the FDA-agreed protocol, without modifications. BioSante’s plans to submit the LibiGel NDA for a product launch in 2012.

“LibiGel remains the only product in the world in Phase III development for the treatment of HSDD,” said Stephen M. Simes, BioSante’s president and chief executive officer. “We expect to announce completion of enrollment in both Phase III efficacy trials in the near-future. With this most recent favorable DMC recommendation, we continue to believe that LibiGel will be the first product approved by the FDA to treat HSDD, in menopausal women.”

Tarsa Completes Phase III Oral Calcitonin Trial

Posted on February 14, 2011 @ 09:52 am

Tarsa Therapeutics, Inc. has completed its global Phase III ORACAL trial with once-daily oral recombinant calcitonin for the treatment of postmenopausal osteoporosis. The multinational, randomized, double-blind, active and placebo-controlled Phase III trial enrolled 565 postmenopausal women with osteoporosis. Calcitonin, an anti-resorptive agent, has been shown to help maintain bone mass by acting on osteoclasts to limit bone resorption.

Tarsa has also initiated a new Phase II study of oral calcitonin for the prevention of postmenopausal osteoporosis. The Phase II prevention trial is a randomized, double-blind, placebo-controlled study designed to enroll approximately 120 postmenopausal women with low bone mass at increased risk of fracture.The trial will assess efficacy in the prevention of bone loss, as well as safety and tolerability.

Tarsa plans to submit a NDA to the FDA for the use of its oral calcitonin as a treatment for postmenopausal osteoporosis later this year, and a MAA to the European Medicines Agency next year.

Calcitonin is currently approved for the treatment of postmenopausal osteoporosis, but its use has been limited because it’s currently available only in intranasal and injectable forms. Tarsa's oral calcitonin product has been shown to deliver the desired blood levels of calcitonin and reduce levels of biomarkers of bone resorption.
Executive Moves: DPT Laboratories

Posted on February 11, 2011 @ 09:11 am

Grant Gilker has been named general manager of operations at DPT’s Center of Excellence for semi-solids and liquids manufacturing facility in San Antonio, TX. Mr. Gilker will be responsible for leadership of all manufacturing functions at the site. His responsibilities include production, logistics, engineering, regulatory compliance and transfer of new processes and products to the site.

Mr. Gilker has 34 years of experience in quality and manufacturing operations, including 21 years in pharmaceutical operations. He joins the company from Pharmetics, Inc., where he served as vice president of operations and sales. He also spent 12 years at Patheon in a variety of positions, including site director for three locations focused on contract manufacturing of OTC products.

“Grant’s background is ideal for his role as general manager of operations at our San Antonio center,” said Mark Fite, DPT’s vice president of operations. “His strong customer focus, experience with quality systems and track record of optimizing plant operations will provide leadership and direction as we continue to refine our manufacturing Center of Excellence strategy.”


Click here to learn more about DPT

Crucell Resolves Issues at South Korea Plant

Posted on February 11, 2011 @ 09:09 am

Crucell NV can resume selling its vaccine Quinvaxem to United Nations agencies, after investigations by the World Health Organization showed the manufacturing problems at Crucell’s plant in South Korea were resolved. Crucell suspended production due to sterility issues at the plant and stopped shipments of two children’s vaccines, including Quinvaxem.

The manufacturing problems resulted in a loss for the company in 2010 and put on hold Johnson & Johnson’s $2.4 billion bid to takeover the company. J&J’s bid expires February 16th; the company currently holds about 18% of Crucell shares.

Executive Moves: Eli Lilly and Co.

Posted on February 11, 2011 @ 09:05 am

Sue Mahony, currently Lilly’s senior vice president of human resources and diversity, has been named senior vice president and president of Lilly Oncology. She will continue to report to Lilly’s chief executive officer, John Lechleiter, Ph.D., and she remains a member of the company’s executive committee. Ms. Mahony succeeds John H. Johnson, who recently resigned.

Steve Fry will take over for Ms. Mahony as senior vice president of HR and diversity. He previously served as vice president of HR for Lilly’s bio-medicines and emerging markets. Mr. Fry joins Lilly’s executive leadership team and reports to Dr. Lechleiter.

“Sue brings a deep understanding of both the scientific and commercial aspects of our business gained through a broad range of leadership roles here at Lilly and with other major pharmaceutical companies,” said Dr. Lechleiter. “Steve is a human resources professional who has also played a critical role in shaping our organizational approach, including the new business areas we formed last year. His varied experiences give him a firm grasp of how our business operates in all parts of the world.”

Ms. Mahony joined the company more than 10 years ago after having held positions with Amgen, Bristol-Myers Squibb, and Schering-Plough in sales and marketing roles in the UK and Europe in oncology/hematology and cardiovascular medicine. She served as general manager of Lilly Canada in 2008 after roles in global marketing and new product development, and was promoted to the top HR role in 2009.

Mr. Fry’s previous roles at Lilly include serving as managing director of Lilly’s Australian affiliate from 2004 – 2007, then in human resources capacities as executive director for the intercontinental region and Japan, and later becoming vice president for bio-medicines and emerging markets. He joined the company in 1987 as a scientific systems analyst at Lilly’s former Greenfield, IN laboratories and moved into HR in 1992.

Executive Moves: INC Research

Posted on February 11, 2011 @ 09:03 am

Shabbir Rangwala, M. has been named executive director, Global Services and site head for INC Research. Also, Sunil Garg M. has been named senior manager of Clinical Operations to help manage India-based clinical trials. They join Bhawana Awasthy, M.D., who was recently appointed senior medical director, Medical Affairs.

“India has continued to be a key region for our customers’ overall drug development strategies. We have been building the right team with the right set of clinical trials services to meet the specific needs in the country,” said Kelvin Logan, Ph.D., president INC Research Europe and Asia Pacific. “Shabbir and Sunil have proven expertise in CRO and other key clinical research settings to enable them to help guide the clinical trials outsourcing process. We are proud to welcome them to our team.”

Mr. Rangwala has 13 years of drug development experience in both CROs and pharmaceutical companies. Prior to joining the company, he held positions at Lilly, GVK Bio and iGATE Clinical Research. His responsibilities have included roles in training, quality, business operations, business development, line management and project management across India, Australia and Hong Kong.

Mr. Garg has extensive experience in establishing and managing the operations of leading CROs in India. During his career, he has worked as a part of global cross-functional teams, responsible for clinical operations, business planning and execution, project management and customer relationship management. Prior to joining INC Research, he led the clinical monitoring group for a large CRO, where he successfully managed all aspects of clinical research operations for Phase I through IV studies across multiple therapeutic areas.

Merck BioManufacturing To Supply MS Drug

Posted on February 10, 2011 @ 08:48 am

Nuron Biotech, Inc. has selected the Merck BioManufacturing Network in the UK to manufacture large-scale GMP clinical supplies of NU100 and to provide process validation leading to long-term commercial operations. NU100, entering Phase III development, is a recombinant human interferon beta compound being developed for the treatment of multiple sclerosis (MS). The manufacturing process uses PreEMT, a new large-scale pressure refold technology, which has been installed at the Billingham, UK site.

“The novel steps in manufacturing that make NU100 unique are important to the success of our product development program,” said Shankar Musunuri, Ph.D., MBA, chief executive officer and founder of Nuron Biotech. “The experience and breadth of capabilities offered by Merck BioManufacturing Network match our needs in both the clinical trial production as well as commercialization of our unique product for patients with MS.”

Steve Bagshaw, site general manager of the Merck BioManufacturing Network at Billingham, said, "We are delighted that Nuron has chosen to work with us, recognizing our many years of development experience in microbial biologics, our focus on introducing new technologies and our capacity that offers appropriate scales for their manufacturing needs."

Evotec To Acquire Kinaxo Biotechnologies

Posted on February 10, 2011 @ 08:46 am

Evotec AG has signed a definitive agreement to acquire Kinaxo Biotechnologies GmbH, a Munich-based drug discovery alliance company, for $4.1 million in cash and an additional $5.4 million if performance-based milestones are achieved. With the acquisition, Evotec gains several technologies designed to help its partners make decisions earlier on drug efficacy, safety and patient response. The transaction is expected to close in April 2011.

Kinaxo's capabilities include Cellular Target Profiling, which is used to uncover molecular targets of compounds with unknown mode-of-action, revealing possible off-target side effects, KinAffinity, used to determine the cellular selectivity of kinase inhibitors, representing an important class of targeted cancer drugs, and PhosphoScout, which provides information on drug modes-of-action in vivo and how they respond to drug treatment.

“Through the acquisition of Kinaxo, Evotec gains access to a highly innovative technology base in drug discovery, which allows us to integrate a powerful response prediction platform with our leading drug discovery expertise. We are proud to significantly strengthen our performance-based discovery offering to our customers with this unique value proposition,” said Dr. Werner Lanthaler, chief executive officer of Evotec AG.

Dr. Andreas Jenne, chief executive officer of Kinaxo, said, "We are excited to join forces with Evotec. Our technology portfolio perfectly fits into Evotec's integrated service offering. This will allow us to fully leverage our capabilities and grow our business much faster within larger discovery alliances."

Capsugel Acquires GSK’s FlexTab Technology

Posted on February 10, 2011 @ 08:44 am

Capsugel has acquired the FlexTab technology, a dosage form developed by GlaxoSmithKline. The technology uses injection molding processes to produce unique capsule-shaped dosage forms that offer a new platform for formulating a wide range of new products. The FlexTab technology allows for a variety of fill materials, including powders, pellets, liquids, micro-tablets and tablets, and can deliver separate liquid and powder API's in one dose, allowing for new product designs and customization options.

“Capsugel is very excited to have this innovative technology as part of our suite of offerings,” said Keith Hutchison, vice president of R&D at Capsugel. “We believe that the FlexTab technology's unique performance characteristics and novel presentation will enable us to formulate the next generation of pharmaceutical and biotech products for our customers. With fewer new drug entities coming to market, our customers are looking for other ways to improve the therapeutic effectiveness of existing API's for patients and consumers, for example through better patient compliance and convenience.”

AndersonBrecon Opens North American Facility

Posted on February 10, 2011 @ 08:42 am

AndersonBrecon Clinical Services has opened a North American clinical services facility in Rockford, IL to serve North and South America. The facility provides on-site packaging, storage, and distribution for investigational products, including cold chain support for refrigerated and frozen products. Lab services include analytical development and testing, and stability studies. The new site will also offer on-site label printing, including randomization generation and multi-language booklets.

The new facility was constructed on the campus of Anderson Packaging’s commercial packaging facilities. The site includes dedicated primary and secondary packaging suites. Primary packaging suites feature class 100M / ISO 8 level clean rooms, with capabilities including over-encapsulation of study and comparator drug product, placebo capsule manufacturing, and packaging of solid oral doses and powders in pouches, bottles, and blisters. The secondary packaging suites can be interconnected for scalable and multi-stage operations. Capabilities include child resistant blister carding, secondary labeling including parenterals and injectibles, as well as kit assembly.

“The new clinical services site in Rockford is well positioned, allowing us to provide our domestic and global customers support services and scalable packaging operations for each stage of the drug development process in both the Americas and Europe,” said Bob Misher, general manager and senior vice president, AndersonBrecon Clinical Services. “We have capabilities for small scale Phase I studies all the way through to large scale Phase III and post-marketing Phase IV studies. Our global teams collaborate for successful study execution, filing, approval and product launch, with a seamless transition to ongoing supply.Our goal is provide our customers full support for the development and commercialization of their product.”


Click here to learn more about AndersonBrecon Clinical Services
Richman Chemical Adds Biotech Capabilities

Posted on February 10, 2011 @ 08:41 am

Richman Chemical, Inc. has expanded its service offerings to include biotechnology services ranging from cell line development to media optimization and process characterization. RCI has a GMP-compliant facility to provide clients with bioprocess optimization, cell banking, in-house microbiology, and virus clearance safety testing requirements. RCI also provides custom chemical synthesis and manufacturing services for small-scale trials and full-scale production of drug substances.

Financial Reports: Sanofi-Aventis

Posted on February 9, 2011 @ 08:19 am

Sanofi-Aventis 4Q10

4Q Revenues: $10.0 billion (8%)

4Q Earnings: $594 million (-67%)

FY Revenues: $40.3 billion (-1%)

FY Earnings: $7.3 billion (-1%)

Comments: Figures are skewed by the 8% drop in EUR to USD exchange rate from 4Q09 to 4Q10 and the 5% drop from FY09 to FY10. At constant exchange rates, 4Q10 revenues were down 6% and FY10 revenues were up 1%. Lantus sales were up 9% for 4Q and FY to $1.2 billion and $4.6 billion, respectively. Lovenox sales were hurt by U.S. generics, dropping 11% for FY to $3.7 billion and 27% in 4Q to $791 million. Taxotere revenues also suffered from generic competition, dropping 20% in 4Q to $620 million and 6% FY to $2.8 billion.
Executive Moves: PPD, Inc.

Posted on February 9, 2011 @ 07:53 am

David L. Grange plans to retire as chief executive officer of PPD, Inc.and a member of its board of directors. Mr. Grange joined the board in 2003 and served as an independent director until mid-2009 when he became chief executive officer. His retirement will be effective May 18, 2011, the date of the company’s annual shareholder meeting.

“I joined PPD as its chief executive officer in July 2009 to bolster the executive management team alongside Fred Eshelman in his new role as executive chairman and to assist the company in responding to what was a very challenging business environment,” said Mr. Grange. “2009 proved to be a difficult year for PPD, but we advanced our strategic and financial objectives over the course of 2010. With the completion of the spin-off of compound partnering and the many accomplishments and progress we made in 2010, I feel my commitment to the board is now fulfilled.”

Mr. Eshelman added, “Under Dave’s leadership, the company was able to address the difficult challenges we encountered in 2009. He and our executive team made steady progress in 2010 and have set the foundation for future growth for PPD and its shareholders. We are grateful for his years of service and his contributions to PPD during a time of significant challenge and change, and we wish him the best in his retirement.”

PPD's board has started the succession planning process and will promptly initiate a search internally and externally for a successor. Mr. Grange will assist in the transition of his duties during the remainder of his tenure as chief executive officer and will continue to provide assistance to the company on transition and other matters under a consulting agreement for the balance of 2011. After his retirement and until a new chief executive officer is in place, his duties will be handled by Dr. Eshelman and other members of PPD’s management team.
Financial Reports: PPD

Posted on February 9, 2011 @ 07:50 am

PPD 4Q10

4Q Revenues: $389 million (+9%)

4Q Earnings: $47 million (+150%)

FY Revenues: $1.4 billion (+4%)

FY Earnings: $124 million (-22%)

Comments: Clinical Development Services revenues were $277 million (+8%) in 4Q10 and $1.0 billion (+1%) in FY. Laboratory Services revenues were $81 million (+14%) in 4Q and $313 million (+14%) in FY.
Financial Reports: Charles River Laboratories

Posted on February 9, 2011 @ 07:38 am

CRL 4Q10

4Q Revenues: $282 million (-3%)

4Q Loss: $348 million (earnings of $17 million in 4Q09)

FY Revenues: $1.1 billion (-3%)

FY Loss: $342 million (earnings of $113 million in FY09)

Comments: CRL wrote down $305 million in goodwill writeoffs in 4Q10, as well as a $90 million writeoff for preclinical facilities in China and Massachusetts. The company considers its Phase I business to be a discontinued operation, but we've included its results in the overall figures. Revenues for Research Models and Services were down 1% to $168 million in 4Q and up 1% to $667 million for the year. Preclinical Services were down 6% in 4Q to $121 million and down 9% for FY to $466 million.
Elan, Boehringer in Antibody Pact

Posted on February 9, 2011 @ 07:23 am

Elan and Boehringer Ingelheim have entered into a global technical development and manufacturing agreement for antibody-based therapeutics. BI will perform technical development, clinical manufacturing and all related regulatory filing support services for antibodies discovered by Elan. Elan will lead the discovery science, preclinical activities, clinical development and commercialization of such antibodies.

Dr Johannes Roebers, senior vice president and head of Biologic Strategy, Planning and Operations at Elan, said, “We are excited to collaborate with Boehringer Ingelheim, a highly regarded and world-class leader in biological technical development and manufacturing. The agreement enables Elan to focus resources on discovery and the clinical progression of our science while leveraging BI’s process development and production capabilities.”

Simon Sturge, corporate senior vice president of the Biopharmaceuticals Division at BI, said, “The combination of Elan’s successful track record in the discovery and clinical development of antibody-based therapeutics with our proven expertise in technical development and manufacturing and in particular our BI HEX platform, will be an optimal fit. This is a first step in our new strategy engaging our technology platforms at a very early stage in product development. We look forward to working with the team at Elan.”

Dr Dale Schenk, executive vice president and chief scientific officer at Elan, added, “This collaboration with BI is highly compelling as it leverages our respective capabilities and provides the opportunity to create significant value for Elan. This business model will enable us to rapidly accelerate the advancement of our next generation antibody programs. These programs are broad in scope and are innovative across technology, targets and possible disease application.”
Financial Report: Elan

Posted on February 8, 2011 @ 09:10 am

Elan

4Q Revenues: $308.9 million (+3%)

4Q Loss: $52.2 million (loss of $57.7 million 4Q10)

YTD Revenues: $1.2 billion (+5%)

YTD Loss: $324.7 million (loss of $176.2 million YTD10)

Comments: Revenue from the BioNeurology business was up 7% for the year boosted by Tysabri sales, while revenue from Elan Drug Technologies (EDT) fell due to reduced revenue from Maxipime, Azactam and Prialt. Revenue growth for the year was attributed to an 18% increase in Tysabri sales to $851.5 million, as well as a 9% drop in operating expenses. Loss for the year includes a settlement reserve charge of $206.3 million for Zonegran.


Click here to learn more about Elan.

DSM, NKT Ink Development Contract

Posted on February 8, 2011 @ 09:07 am

DSM Biologics has signed a contract with NKT Therapeutics, Inc. for the process development and cGMP manufacture of NKT’s lead product iNKT mAb. NKT, based in Waltham, MA, is a biotechnology company that focuses on developing therapeutics based on immune cells called natural killer T (NKT) cells. Financial terms of the contract were not disclosed.

NKT cells are a central part of the immune system. When exposed to microbial and viral pathogens, NKT cells secrete high levels of specific cytokines, which stimulate the immune system to eliminate pathogens.

Karen King, president of DSM Biologics, said, "We are delighted to be working with NKT Therapeutics, based in the U.S., from our European biomanufacturing operations in Groningen, the Netherlands.We are truly honored to be supporting their first clinical program from our cGMP operations."

Dr. Robert Mashal, president and chief executive officer of NKT Therapeutics, said, "For NKT, advancing our lead program into cGMP manufacturing marks a significant milestone for the company, and we are certain we have found the right partner in DSM."


Click here to learn more about DSM.
Financial Report: BASi

Posted on February 8, 2011 @ 09:05 am

BASi

1Q Revenues: $8.1 million (+27%)

1Q Earnings: $310,000(loss of $1.5 million 1Q10)

Comments: Results reflect higher revenues in both the service and product segments, as well as $265,000 of reduced operating expenses. Service revenue was up 28% to $6.1 million in the quarter and product revenue was up 24% to $1.9 million.


Click here to learn more about BASi.

ScinoPharm To Supply Antidepressant API

Posted on February 8, 2011 @ 09:04 am

ScinoPharm has been selected by Clinical Data, Inc. to provide the manufacture of vilazodone hydrochloride API for Viibryd, a recently FDA-approved antidepressant. Viibryd is for the treatment of adults with major depressive disorder (MDD). The drug is different from other antidepressants in that it does not cause significant weight gain or interference with sexual function.

"ScinoPharm is proud of the fruitful partnership with Clinical Data by being its sole API supplier of vilazodone hydrochloride during Viibryd's launch. Beginning from process research through timely development and optimization of long and complicated synthetic processes, we have established a win-win partnership," said Dr. Jo Shen, president and chief executive officer of ScinoPharm.

Particle Sciences, Horiba in Alliance

Posted on February 7, 2011 @ 12:11 pm

Particle Sciences has established a strategic alliance with Horiba Instruments. Particle Sciences will offer the full array of Horiba characterization tools, while Horiba willbe able to refer clients for cGLP/cGMP development and characterization.

Dr. Robert Lee, vice president of Pharmaceutical Development at Particle Sciences stated, "The need for particle size analysis and physical characterization in general is growing rapidly within this highly regulated environment. Particle Sciences is a world leader in particulate formulations and drug/device combination products. We looked for a partner that shared the same commitment to quality and innovation and Horiba fit the bill."

Dr. Mike Pohl, Horiba's vice president, commented, "Our client base ranges from startups to the largest multinational pharma and biotech companies. For a variety of reasons, we are often asked if we can recommend a site familiar with pharmaceutical development at which they could have work performed. We have worked with Particle Sciences for some time and have been impressed with their facility and their team. By entering into this relationship, we can ensure that our clients not only gain access to the most advanced technology, but also that the operators are highly trained to use the instruments to their fullest capability."
Almac Opens Analytical Labs in New U.S. HQ

Posted on February 7, 2011 @ 07:47 am

Almac has opened analytical laboratories at its new 240,000-sq.-ft. North American Headquarters in Souderton, PA. The move is part of the Almac Group’s integrated services solutions strategy.

The site's analytical labs complement existing facilities in the UK. The lab provides support for clinical packaging operations as well as stand-alone analytical services. The labs are equipped with the latest equipment, including HPLC, UPLC, GC, UV, IR, DSC, KF and others. The new group will also offer Polymorph and Salt Screening and Solid Form Development, according to an Almac statement.

Almac has installed the latest bathless dissolution apparatus for rapid and efficient comparative dissolution studies. Installation of the newest Waters H-Class HPLC/UPLC systems provides maximum flexibility for developing, validating and running assay, dissolution and stability methods. Large capacity stability chambers provide required ICH stability conditions in the new labs.

The new analytical facility complements Almac’s specialty capabilities, including biocatalysis, radiolabeling, and peptide and protein synthesis. These services are all part of Almac’s comprehensive Drug Development Services, including API and drug product development and GMP manufacture.
Financial Reports: AMRI

Posted on February 7, 2011 @ 07:41 am

AMRI 4Q10

4Q Revenues: $48.6 million (+12%)

4Q Loss: $49.1 million (loss of $19.2 million in 4Q09)

FY Revenues: $198.1 million (+1%)

FY Loss: $62.9 million (loss of 16.7 million in FY09)

Comments: Contract revenues rose 16% in 4Q10 to $40.7 million, including a 48% bump in Large Scale Manufacturing to $19.1 million. Development/Small Scale Manufacturing revenues were up 12% to $10.5 million, marking the first quarter since 4Q08 to show growth. Discovery services dropped 13% to $11.1 million. For FY, Discovery services were down 2% to $46.8 million, Development/Small Scale Manufacturing was down 4% to $36.5 million, and Large Scale Manufacturing revenues were up 13% to $79.9 million. Allegra royalties were flat at $34.8 million. In 4Q10, AMRI took a $1.2 million charge related to an FDA warning letter received by its Burlington, MA parenteral dosage facility.
Executive Moves: Patheon

Posted on February 7, 2011 @ 07:33 am

James C. Mullen has been named chief executive officer of Patheon, effective immediately. Mr. Mullen has also been appointed a director of Patheon's board of directors.

Ramsey Frank, Patheon's chairman, stated, "The Board of Directors is very pleased that Jim Mullen will be joining Patheon. Mr. Mullen's extensive pharmaceutical manufacturing background and proven track record of driving growth and profitability give us confidence that, under his leadership, Patheon will be able to realize its full potential as an industry leader."

Mr. Mullen was most recently with Biogen Idec, Inc., where he held the position of chief executive officer and president for 10 years. Mr. Mullen held those roles at Biogen, Inc. from 2000 to 2002, and was also chairman until 2003, when he led Biogen's merger with Idec. Prior to that, Mr. Mullen held various operating positions at Biogen, including vice president, Operations, and several manufacturing and engineering positions over a nine-year period at SmithKline Beckman, Inc.

Mr. Mullen's 30-year career includes extensive experience in pharmaceutical and biotech manufacturing, engineering, sales, marketing, mergers and acquisitions. Mr. Mullen's breadth of industry experience includes biotechnology, pharmaceuticals and specialty chemicals.

Mr. Frank remarked, "The board also wants to thank Peter Bigelow, Patheon's President of North American Operations, for assuming the role of interim chief executive officer while the search for the new CEO was conducted. His stewardship in this role over the last two months is greatly appreciated and we look forward to Peter's continuing role as a key Patheon executive."

Read our interview with Mr. Bigelow in the January/February 2010 issue of Contract Pharma!
SCM Selected for Ketensin Supply

Posted on February 4, 2011 @ 09:28 am

ProStrakan Group has awarded SCM Pharma a five-year contract for the ongoing supply of its licensed product, Ketensin. SCM will be responsible for the filling of the 2ml and 10ml vial presentations, sterilization, finished product testing and supply of the product.

Ketensin is indicated for the treatment of hypertensive crisis during and after surgery, and is marketed by ProStrakan in the Netherlands. It is a niche product and requires relatively limited supply.

David Traynor, senior vice president of manufacturing and pharmaceutical sciences at ProStrakan, said, “With regular demand for Ketensin in the Netherlands, we required a manufacturing partner that could not only sterile fill into various sizes of vials and test the finished products, but that could reliably deal with smaller commercial quantities. Having completed the technical transfer and geared-up for the Process Qualification batch already, we have been impressed by the customer interaction, willingness and technical ability demonstrated by SCM Pharma and look forward to working with the team on an ongoing basis.”

Dianne Sharp, managing director at SCM Pharma, remarked, “We are delighted to have secured a long-term deal with such a fast-growing high-profile client and are looking forward to meeting ProStrakan’s supply needs for Ketensin over the next few years and beyond. This type of product not only complements our core capability of filling and sterilizing small batches of glass vials but also makes optimum use of the in-house microbiology, chemistry and sterility testing services that our facility offers clients."

This contract follows the opening of SCM Pharma’s first U.S. office at the end of last year, aimed at growing the company’s export revenue and better serving U.S.-based clients.


Click here to learn more about SCM Pharma
Galapagos, Merck End Alliance

Posted on February 4, 2011 @ 09:26 am

Merck and Galapagos NV have agreed to end their development alliances, and Galapagos has regained worldwide rights for all assets in the programs. Merck will make a payment of $16.5 million to Galapagos for work completed in 2010. Galapagos has received a total of $28.7 million in upfront and milestone payments from the alliance and has regained worldwide rights to the targets discovered and assays developed from the collaboration.

“Changes in our early discovery strategy have required us to make some challenging decisions,” said Kathleen Metters, senior vice president, External Discovery and Preclinical Sciences, at Merck. “We look forward to investigating alternate opportunities to collaborate with Galapagos in the future.”

“In the alliances with Merck, we have discovered promising targets and developed target discovery assays for diseases with considerable unmet medical needs. Galapagos now owns these valuable assets which can form the basis for future alliances,” said Onno van de Stolpe, chief executive officer of Galapagos. “The work delivered to Merck last year also made a strong contribution to Galapagos' financial results in 2010.”

AMRI Receives AIFA Certification

Posted on February 4, 2011 @ 09:23 am

AMRI has received approval from the Italian Medicines Agency (AIFA) for its Burlington, MA facility to manufacture the commercial drug product octreotide for a customer in the EU.

This approval is a result of the successful completion of an AIFA audit of AMRI’s sterile fill/finish facility. This certification specifically applies to labs and manufacturing areas designed for the production of aseptic and lyophilized vials, affirming compliance with EU GMP standards.

“Receiving AIFA certification demonstrates AMRI’s continued commitment to provide customers with products that meet the highest standards for quality, regulatory, safety and environmental compliance,” said AMRI chairman, president and chief executive officer Thomas E. D’Ambra, Ph.D. “AMRI remains vigilant in its quality practices to ensure that the same level of excellence is delivered and adhered to at all times at all locations around the globe.”


Click here to learn more about AMRI.
Executive Moves: Aesica

Posted on February 4, 2011 @ 09:21 am

Aesica Pharmaceuticals has appointed a team to manage its new European operation following the recent acquisition of three manufacturing sites from UCB in Germany and Italy. The three manufacturing sites are located in Monheim, Zwickau and Pianezza.

Simon Clough has been appointed managing director of the Formulated Products Business Unit, based at the Monheim site. Katy Lineker will serve as finance director of the unit. Also, three long-time Aesica employees have been appointed to support and facilitate the transition following the completion of the acquisition in early 2011: Janette Waterhouse will be based at Zwickau for three months, Ed Wood will spend three months at Pianezza, and Helen Taylor will relocate to Monheim for three months.

Mr. Clough commented, “The acquisition of the three UCB manufacturing sites is strategically crucial for our business as we extend and enhance our current offering and establish a presence in Europe. To have been given the responsibility of directing operations for the Formulate Products Business Unit is an honor and I am committed to ensuring we build upon the strategic partnership we have formed with UCB, as well as introducing new lines of business across the sites. Aesica’s vision is to become the leading supplier of Formulated Products and APIs and I believe that our European operation will play a pivotal role in achieving this.”

Financial Reports: GlaxoSmithKline

Posted on February 3, 2011 @ 08:11 am

GSK 4Q10

4Q Revenues: $11.4 billion (-13%)

4Q Loss: $955 million(earnings of $2.6 billion in 4Q09)

FY Revenues: $44.0 billion (-1%)

FY Earnings: $2.9 billion (-67%)

Comments: U.S. pharma sales for the year dropped 11% to $11.9 billion, while European sales dropped 7% to $10.1 billion. Emerging markets rose 22% to $5.5 billion in that span. The vaccine segment overall grew 15% to $6.7 billion. Generic exposure for Valtrex and Avandia's continuing death-spiral impacted revenues for 4Q and FY. Valtrex sales were $152 million (-60%) for 4Q and $823 (-60% from $2.0 billion) for FY. The 4Q loss was driven by $3.2 billion in legal costs and $450 million in restructuring costs. GSK announced plans to sell off non-core OTC consumer health brands that add up to around $750 million in annual sales. The company also sold its share in Quest diagnostics for $1.1 billion (after tax) this week and sold its interest in Zovirax to Valeant for $300 million.
Executive Moves: INC Research

Posted on February 3, 2011 @ 07:27 am

Kathy Bohannon has been named principal strategist, Pediatrics, at INC Research. She is responsible for developing the operational strategy and providing expertise in the design and execution of pediatric studies.

“Kathy is enhancing our unique team model that leverages our deep therapeutic and regulatory expertise to develop a more holistic approach to pediatric trials,” said John Potthoff, INC's chief operating officer. “Throughout her impressive career, Kathy has developed and managed pediatric trials across multiple therapeutic areas, clinical settings and pediatric age groups. She will be an invaluable addition to our leadership team as we raise our pediatrics services to a new level.”

Ms. Bohannon comes to INC Research from Premier Research Group where she was the senior director, Clinical Trial Management. In that role, she was project administrator responsible for all contractual, regulatory and project management activities within the Best Pharmaceuticals for Children Act – Coordinating Center (BPCA-CC). Her pediatric experience also includes protocol and program development in compliance with FDA PREA, BPCA legislation, and the European Paediatric Regulation, with recent experience in support of pediatric acute and chronic pain.
Executive Moves: NextPharma

Posted on February 3, 2011 @ 07:24 am

Brigitte Genard has been named quality director at NextPharma Technologies' sterile contract development and manufacturing site in Braine-l’Alleud, Belgium. Ms. Genard will take responsibility for all aspects of quality across the site, including the recently FDA- and PDMA-inspected contract manufacturing plant which produces oncology products in commercial quantities and the Sterile Product Development Center.

Ms. Genard is an industrial pharmacist with 18 years of experience in Quality Assurance and Production. She has extensive experience in biopharmaceutical manufacturing, has worked for 15 years in industrial vaccine operations (bulk and secondary) and has previously worked for GSK Biologicals and UCB Bioproducts as senior quality assurance manager and head of production.

Bill Wedlake, NextPharma's chief executive officer, commented, "We are delighted to have Ms. Genard join our management team heading up the Quality function in Braine-l’Alleud. Her broad experience across our industry will enhance our ability to match the demands of our customers ensuring that NextPharma remains at the forefront of timely, competitive, healthcare outsourcing solutions of the highest quality."
Financial Reports: Merck & Co.

Posted on February 3, 2011 @ 06:58 am

Merck 4Q10

4Q Revenues: $12.1 billion (+20%)*

4Q Loss: $531 million (earnings of $6.5 billion in 2009)

FY Revenues: $46.0 billion (+68%)*

FY Earnings: $982 million (earnings of $13.0 billion in 2009)

Comments: Revenues and earnings were skewed as a result of the Schering-Plough acquisition, which closed in 4Q09. Pro-rated figures would have left human health revenues down 2% for 4Q and -1% for FY. Cozaar/Hyzaar posted a 57% drop in sales in 4Q ($415 million) and fell 41% for FY ($2.1 billion). Januvia and Janumet sales rose 27% in 4Q10 to $962 million million, and 29% in FY to $3.3 billion. Gardasil rvenues fell 20% in 4Q to $221 million and 12% to $988 million in FY, as stockpiling sales ended after 2009. Merck wrote down $1.7 billion related to development of vorapaxar, which is apparently finished after trials were halted in January. That cancellation was cited by the company when it reduced its earnings projections through 2013 from high single-digits to low-to-mid-single-digits.

* Revenues for 2009 do not include all Schering-Plough legacy revenues. With those included, 4Q10 revenues were down 1% and FY revenues were flat. Earnings were affected by the 2009 closing as well as the sale of Merck's interest in Merial.
Financial Report: Hospira

Posted on February 2, 2011 @ 09:05 am

Hospira 4Q10

4Q Revenues: $992.1 million (-6%)

4Q Earnings: $60.6 million (-37%)

FY Revenues: $3.9 billion (+1%)

FY Earnings: $357.2 million (-12%)

Comments: Global Specialty Injectable Pharmaceuticals sales in the quarter were $605.0 million, (+5%). Sales in the Americas were up 4%, Europe, Middle East & Africa sales were up 1%, and Asia Pacific sales were up 10%. For the year, Global Specialty Injectable Pharmaceuticals sales were $2.3 billion, up 13%. Sales in the Americas were up 15%, Europe, Middle East & Africa sales were up 4%, and Asia Pacific sales were up 12%. Results were impacted by a decline in Medication Management, primarily due to the voluntary hold on shipments of Symbiq Infusion System, and the decline in Other Pharma, as a result of the impact of non-strategic asset divestitures.
Financial Reports: Roche

Posted on February 2, 2011 @ 08:45 am

Roche FY10

FY Revenues: $45.6 billion (+1%)

FY Earnings: $8.6 billion (+9%)

Comments: The company weathered the absence of Tamiflu revenues to post slight overall FY growth. Pharmaceutical sales dropped 2% to $35.6 billion. U.S. pharma sales dipped slightly to $13.5 billion, while Western Europe dropped 5% to $9.1 billion. International pharma sales (non-U.S., Western Europe or Japan) were up 8% to $8.8 billion. The company contends that U.S. healthcare reform and European austerity measures led to a $337 million hit in revenues. Avastin sales in the U.S. were flat at $3.1 bilion, while Lucentis sales rose 27% to $1.4 billion.
Financial Reports: Novo Nordisk

Posted on February 2, 2011 @ 08:31 am

Novo Nordisk 4Q10

4Q Revenues: $2.9 billion (+14%)

4Q Earnings: $720 million (+56%)

FY Revenues: $10.9 billion (+13%)

FY Earnings: $2.6 billion (+27%)

Comments: Diabetes care revenues for FY were $8.1 billion (+16%), while FY Biopharma revenues were up 5% to $2.7 billion. Modern insulins were up 18% for $4.7 billion in revenues during the year. Sales of Victoza, a GLP-1 therapy for type 2 diabetes, posted $413 million in FY revenues. Earnings in 4Q10 and FY were boosted by $200 million from the October 2010 sale of shares in Zymogenetics, Inc.
Financial Reports: Thermo Fisher Scientific

Posted on February 2, 2011 @ 08:07 am

Thermo Fisher Scientific 4Q10

4Q Revenues: $2.8 billion (-2%)

4Q Earnings: $298 million (+9%)

FY Revenues: $10.8 billion (+7%)

FY Earnings: $1.0 billion (+22%)

Comments: Analytical Technologies revenues were $1.2 billion for 4Q10 (+4%) and $4.6 billion for FY (+11%). Laboratory Products and Services were -6% for 4Q10 ($1.7 billion) and +4% for FY ($6.7 billion). Acquisitions accounted for 3% of FY revenue growth and 2% of 4Q10 revenue growth. The company predicts revenue growth of 5-6% in 2011, not including sales generated by the Dionex acquisition, which has not yet closed.
Carbogen Amcis Boosts Stability Capabilities

Posted on February 2, 2011 @ 07:44 am

Carbogen Amcishas enhanced its stability chambers in compliance with the latest International Conference on Harmonization (ICH) guidelines. According to the company, the move boosts its service portfolio for stability studies: short-term, long-term, accelerated, intermediate, follow-up and customized tests.

The company’s new fully validated and mapped stability chambers operate at ICH conditions (25°C/60% RH, 30°C/65% RH, and 40°C/75% RH) and at low temperatures (5°C, -20°C and -80°C). With an increased shelf storage capacity of about 92 m2, they provide secure and safe storage for API samples, including high potency material, employed for in-house stability studies.

“The completion of new state-of-the-art stability chambers strongly enhances Carbogen Amcis’ service portfolio and confirms our ongoing commitment in providing our customers with the best innovative, timely and safe drug development solutions,” said Mojmir Vavrecka, Carbogen Amcis' chief executive officer. "We are facing an increasing customer demand for stability studies tied to our API development and production efforts. This expansion meets our customers’ needs.”
Executive Moves: Pfizer

Posted on February 1, 2011 @ 08:15 am

Dr. Yvonne Greenstreet has been appointed senior vice president and head of medicines development for Pfizer’s Specialty Care Business Unit. Dr. Greenstreet will assume global responsibility for leading the advancement of the development portfolio and ensuring its alignment with Specialty Care’s strategic objectives. Dr. Greenstreet replaces Dr. Michael Berelowitz, who is retiring from the company. She will report directly to Mr. Germano.

“Yvonne has a strong track record of leadership and outstanding results during her career in the biopharmaceutical industry,” said Geno Germano, president and general manager of Pfizer’s Specialty Care Business Unit. “Her experience in delivering medicines in challenging markets is noteworthy, and she will play an important role in advancing Specialty Care’s commitment to the eradication, remission and relief of serious diseases.”

Dr. Greenstreet joins the company after an 18-year career with GlaxoSmithKline (GSK), where she most recently was senior vice president and chief of strategy, R&D. Her R&D work spans clinical development, medical affairs, health economics, outcomes research, regulatory affairs and portfolio management. At GSK, she was responsible for leading the development of small molecules and biologics in several therapeutic areas, including musculoskeletal, immunology/inflammation, gastrointestinal, urology, ophthalmology and anti-infectives. She had also been responsible for clinical development and medical affairs for GSK’s European business.
Financial Reports: Pfizer

Posted on February 1, 2011 @ 07:38 am

Pfizer 4Q10

4Q10 Revenues: $17.6 billion (+6%)

4Q10 Earnings: $2.9 billion (+277%)

FY Revenues: $67.8 billion (+36%)

FY Earnings: $8.3 billion (-4%)

Comments: U.S. revenues dropped 3% in 4Q10 to $7.2 billion, while international sales were up 13% to $10.3 billion. For the year, revenues were up $17.8 billion, but the company received a boost of $18.1 billion from legacy Wyeth products and $1.1 billion from exchange rates. Legacy Pfizer products were down 3% for FY. The company announced a $5 billion share buyback program, and plans to cut 2012 R&D to approximately $6.5 to $7.0 billion; 2010 R&D expenditure was $9.4 billion, and included some integration costs. For 2011, the company predicts flat sales, followed by a single-digit decline in 2012. In a statement, new president and chief executive officer Ian Read said the company will look to "an increased level of outsourcing for services that do not drive competitive advantage for Pfizer." Lipitor sales dropped 17% in 4Q10 to $2.6 billion, led by a 26% fall in international sales.
Financial Reports: Biogen Idec

Posted on February 1, 2011 @ 07:15 am

Biogen Idec 4Q10

4Q10 Revenues: $1.2 billion (+8%)

4Q10 Earnings: $272 million (-11%)

FY Revenues: $4.7 billion (+8%)

FY Earnings: $899 million (-8%)

Comments: Avonex sales rose 8% for the year to $2.5 billion and 10% for 4Q10 to $654 million. Tysabri revenues rose 16% for FY to $900 million and 12% to $242 million in 4Q10. Tysabri sales were split nearly 50/50 between U.S. and non-U.S. markets. Rituxan revenues dropped 2% to $1.1 billion for the year, due to expiration of royalties on non-U.S. sales
Executive Moves: AMRI

Posted on February 1, 2011 @ 07:10 am

Lori M. Henderson has joined AMRI as vice president, general counsel and secretary. She will report to Thomas E. D’Ambra, AMRI's chairman, president and chief executive officer.

Ms. Henderson will be responsible for leading all of AMRI’s legal and corporate affairs activities for the company’s locations worldwide, including the U.S., Europe and Asia. Previously, she served as general counsel, corporate secretary and chief administrative officer for Rand Worldwide, Inc. Prior to that, she was general counsel, corporate secretary and chief administrative officer for Moldflow Corporation. She also served as corporate counsel and clerk at CP Clare Corporation and was an associate at Goodwin Procter LLP.
Laureate Pharma Becomes Biopharma

Posted on February 1, 2011 @ 06:47 am

Laureate Pharma, Inc. has changed its name to Laureate Biopharmaceutical Services, Inc. to better describe the company’s positioning in the biopharmaceutical industry. The company has also updated its logo to emphasize “Laureate” and to incorporate a laurel wreath, illustrating Laureate Biopharma’s reputation for scientific excellence and commitment to delivery, according to a company statement.

Laureate Biopharma has been in continuous operation in its Princeton, NJ facility since 1981. Since 1996, Laureate Biopharma has focused exclusively on serving other developers in the biotherapeutics market.

“We are building on Laureate Biopharma’s rich history and adding technologies, capacity and staff, while extending our reputation for quality and delivery,” said Michael A. Griffith, Laureate's chief executive officer. “This name change, although subtle, speaks to our wealth of experience in protein production and a deep scientific bench, which is unique to the industry.”

This name change follows the company’s recent announcement of $20 million in secured capital. Laureate's previously announced strategically planned improvements are ongoing. These include:
  • Adoption of new quality systems technologies
  • Upgrade of aseptic fill capabilities
  • Upgrade and expansion of protein production facilities and services
  • Expansion of mammalian cell line creation services, and
  • Launch of a contract analytical testing business

January 2011

Catalent in MS Drug Manufacturing Pact

Posted on January 31, 2011 @ 08:04 am

Catalent Pharma Solutions has entered into an agreement with Nuron Biotech for the formulation and supply of NU100 (interferon beta-1b), a proprietary recombinant human interferon beta compound being developed for the treatment of multiple sclerosis (MS).

NU100 will be produced at Catalent’s facility in Brussels, Belgium, where this injectable product will be formulated, filled and packaged in a prefilled syringe. Nuron Biotech is currently planning to take NU100 into Phase III clinical trials in 2011.

“For decades, Catalent’s sterile technology business has a proven track record of partnering with innovators like Nuron Biotech to efficiently take products to market faster. We are excited to have the opportunity to apply our sterile delivery expertise to support Nuron through this complex and important stage of product development,” said Sheila Dell, Ph.D., vice president Business Development, Catalent. “In addition to preparing and supplying NU100 for Phase III trials, we are pleased to be able to support commercial manufacturing during the product’s first three years on the market.”

“Our senior managers have come to know and trust the Catalent team during previous business relationships, and we are pleased to re-establish this mutually beneficial partnership,” commented Nuron Biotech's chief executive officer and founder, Shankar Musunuri, Ph.D., MBA. “We have strong confidence in Catalent’s ability to support Nuron with NU100 and with other future scale-up and launch opportunities.”
Alexion Acquires Taligen

Posted on January 31, 2011 @ 07:53 am

Alexion Pharmaceuticals has acquired Taligen Therapeutics, a privately held development-stage biotechnology company based in Cambridge, MA. The $111 million acquisition broadens Alexion’s portfolio of product candidates and expands Alexion’s capabilities in translational medicine by bringing in additional researchers. Taligen has a number of preclinical compounds, including potential treatments for patients with ophthalmic diseases such as age-related macular degeneration (AMD), as well as other novel antibody and protein regulators of the complement inflammatory pathways.

The acquisition was completed with an upfront cash payment for 100% of Taligen’s equity interests. Additional contingent payments would be earned upon reaching various clinical efficacy and product approval milestones in both the U.S. and European Union for up to six products.

“Taligen’s talented scientists and impressive technology will enhance Alexion’s world-class staff and breakthrough research and development programs, substantially increasing our ability to develop first-in-class therapies for patients with severe diseases,” said Leonard Bell, M.D., chief executive officer of Alexion. “As product development opportunities continue to expand, we look forward to increasing the quality, speed, and throughput of our combined current and future development programs for the benefit of patients worldwide.”

Taligen’s scientific staff will form the nucleus of Alexion’s new Cambridge Massachusetts-based Translational Medicine Group, headed by Abbie Celniker, Ph.D., former chief executive officer of Taligen and now head of Translational Medicine at Alexion. Dr. Celniker will report to Stephen Squinto, Ph.D., executive vice president and head of R&D at Alexion.

“Alexion has proven how highly innovative science can result in life-transforming therapies for patients with debilitating disorders,” said Dr. Celniker. “We are excited to be combining our R&D capabilities with Alexion’s global team with the goal of accelerating the investigation of novel molecules from our combined portfolios and developing additional first-in-class compounds.”
MorphoSys Hits Milestones

Posted on January 31, 2011 @ 07:49 am

MorphoSys AG has received milestone payments from two partners in its HuCAL-derived fully human antibody program. Pfizer delivered an undisclosed payment in connection with the IND filing in December 2010 and subsequent initiation of a Phase I trial one such antibody in the therapeutic area of oncology. MorphoSys also received payment from OncoMed when the program for antibody OMP-59R5 reached Phase I in patients with advanced solid tumors. That antibody is part of OncoMed's Notch pathway collaboration with GlaxoSmithKline.

"We are delighted to add Pfizer to the list of partner companies running clinical trials with HuCAL-based antibodies," commented Dr. Marlies Sproll, chief scientific officer of MorphoSys AG. "In total, seven different partners from the pharmaceutical and biotechnology industry are currently running clinical trials with our antibodies."

MorphoSys and Pfizer originally entered a collaboration for the development of therapeutic antibodies in December 2003. In December 2006, the collaboration was expanded, giving Pfizer an option to begin several therapeutic antibody projects with MorphoSys.

OncoMed Pharmaceuticals signed a license agreement in June 2006 on the use of MorphoSys's HuCAL technology in the R&D of human therapeutic antibodies for the treatment of various cancers, including breast, lung, colon and prostate cancer, by targeting cancer stem cells. In June 2008, the collaboration was extended until the end of May 2010. The contract included an option for OncoMed to develop as many as five HuCAL-derived therapeutic antibodies.

"This promising new program with OncoMed is MorphoSys's first HuCAL drug candidate targeting a validated cancer stem cell pathway," commented Dr. Sproll. "Cancer stem cells potentially offer one of the most attractive targets for attacking a range of tumor types, making this program an exciting addition to the overall pipeline of HuCAL-based drugs. This is one of eight partnered programs that moved into the clinic in 2010."

MorphoSys's clinical pipeline currently comprises 10 partnered programs in Phase I and five in Phase II development as well as the Company's proprietary programs MOR103, which is in a Phase Ib/IIa trial for rheumatoid arthritis, and MOR208, which is in a Phase I trial for chronic lymphocytic leukemia.
Genzyme, Sanofi Advance Negotiations

Posted on January 31, 2011 @ 07:38 am

Genzyme and Sanofi-Aventis have moved onto a new stage in their merger negotiations. Genzyme’s board has authorized the company to enter into a confidentiality agreement with Sanofi in order to allow Sanofi to conduct due diligence. Discussions between the companies' advisors and representatives are ongoing and are focused on the potential use of a contingent value right for alemtuzumab as a part of a potential resolution of the differences in valuation between the parties. The two sides have also discussed other potential terms for a negotiated transaction.
Executive Moves: Cook Pharmica

Posted on January 31, 2011 @ 07:08 am

E. Morrey Atkinson, Ph.D., has joined Cook Pharmica as vice president of R&D and chief scientific officer. Dr. Atkinson will be responsible for guiding the company's scientific direction, relying on his extensive past experience with process development of gene therapies, vaccines, recombinant proteins and monoclonal antibodies.

“Morrey comes to us with a broad background of scientific and business experience in both the domestic and international marketplace,” said Tedd Green, president of Cook Pharmica. “His broad technical, management and leadership experience will be a great strength to our team and we are proud to welcome him to the Cook organization.”

Dr. Atkinson has almost two decades of experience in biologics development and has held various leadership positions in biotechnology manufacturing and development. Most recently, he was head of biotechnology manufacturing sciences and technology for Eli Lilly and Company in Kinsale, Ireland.

“I look forward to contributing my experience with biologics development to this organization,” Dr. Atkinson said. “With the potential to offer the broadest range of development and production services in the industry, Cook Pharmica has a bright future ahead, and I am excited to join this leadership team.”
PharmaNet, Anapharm Europe End Joint Venture

Posted on January 28, 2011 @ 08:45 am

PharmaNet Development Group, Inc. and Anapharm Europe, S.L., have ended their bioanalytical services joint venture as of December 22, 2010. As part of the termination, Dr. Maria Cruz Caturla, Anapharm Europe's majority shareholder, has purchased PharmaNet's minority ownership interest, becoming the sole owner of the company.

The companies will independently continue to provide bioanalytical services to clients from their respective lab facilities, and, if necessary, will work together to support client projects undertaken during the term of the joint venture.

JHP Pharmaceuticals, Putney Enter Manufacturing Pact

Posted on January 28, 2011 @ 08:40 am

JHP Pharmaceuticals has entered into a multi‐year contract with Putney, Inc., a provider of veterinary pharmaceutical products. JHP will manufacture and supply a lyophilized veterinary product. JHP recently completed the installation and qualification of a new 240 sq.-ft. lyophilizer at its Rochester, MI manufacturing site.

Jean Hoffman, chief executive officer and founder of Putney, said, “We are pleased to partner with JHP Pharmaceuticals in the manufacture and supply of this significant product in veterinary healthcare.”

Stuart Hinchen, president and cofounder of JHP, stated, “We are very pleased that JHP was chosen by Putney. Our experienced staff, customercentric approach and cGMP compliance record will allow us to effectively serve this important customer.”


Click here to learn more about JHP Pharmaceuticals
OSO Bio VP Elected to PDA Board

Posted on January 28, 2011 @ 08:36 am

Susan Schniepp, vice president of quality at OSO BioPharmaceuticals Manufacturing, LLC, has been elected to the board of directors at the Parenteral Drug Association (PDA). Her term on the board of directors is for two years.

Ms. Schniepp has served on numerous PDA committees and was a featured speaker at events. She received PDA’s Distinguished Author Award for her book, Understanding the United States Pharmacopeia and the National Formulary: Demystifying the Standards-Setting Process, as well as the Distinguished Service Award in 2008 and the Gordon Personeus Award in 2010, honoring her contributions to the organization.

“Sue is a shining star within our industry for her unflagging commitment to high quality and her willingness to share her knowledge and experience with others,” said Stuart Rose, president and chief executive officer of OsoBio. “Serving on the PDA board affords Susan yet another opportunity to spread the quality message and lead by example.”

At OsoBio, Ms. Schniepp is responsible managing all operational quality-related issues for cGMP compliance of facilities. She is also responsible for regulatory affairs, records and filings.


Click here to learn more about
OSO BioPharmaceuticals
Executive Moves: AMRI

Posted on January 28, 2011 @ 08:34 am

Takeshi Yura, Ph.D. has been appointed assistant director, medicinal chemistry at AMRI. Dr. Yura reports to managing director Raymond Yeung at the company’s drug discovery services operations in Singapore.

Dr. Yura has more than 22 years of scientific and leadership experience in discovery chemistry, project management and business development. Most recently, he was a director at Dishman Japan Ltd., responsible for sales and business development activities for contract manufacturing services. Prior to that, he served as discovery chemistry research head at Pfizer Japan, dedicated primarily to pain and gastrointestinal drug discovery. He also served as section head, medicinal chemistry at Bayer Yakuhin, focused on urology and asthma.

“We are very pleased to welcome Dr. Yura to our AMRI leadership team,” said Raymond Yeung. “His extensive experience as both a scientist and project leader will contribute significantly to the rapid growth and expansion we are experiencing in Singapore. The addition of Dr. Yura expands further our ability to provide integrated discovery services to our growing base of customers in Japan, throughout Asia and around the globe.”

Click here to learn more about AMRI

Financial Reports: AstraZeneca

Posted on January 27, 2011 @ 10:40 am

AstraZeneca 4Q10

4Q Revenues: $8.6 billion (-4%)

4Q Earnings: $1.6 billion (+4%)

FY Revenues: $33.3 billion (+1%)

FY Earnings: $8.1 billion (+7%)

Comments: Pharma sales in the U.S. were down 12% due to generic competition and the absence of H1N1 pandemic vaccine revenues. Crestor sales rose 26% in 4Q10 to $1.6 billion and 24% for FY to $5.7 billion. Seroquel sales were up 9% for the year to $5.3 billion, driven by growth in the XR formulation. Symbicort sales were up 15% for 4Q10 to $741 million and 20% for FY to $2.7 billion. Arimidex sales in the U.S. plummeted as a result of generic competition in 4Q10, dropping 90% to $22 million. Its EU patent protection expires in February 2011. 4Q earnings were impaired by a $445 million charge relate to canceling development of Motavizumab for RSV.
Financial Reprots: Amylin

Posted on January 27, 2011 @ 08:27 am

Amylin 4Q10

4Q Revenues: $174 million (-6%)

4Q Loss: $19 million (loss of $50 million in 4Q09)

FY Revenues: $669 million (-12%)

FY Loss: $152 million (loss of $13 million in FY09)

Comments: Byetta sales dropped 16% in 4Q10 to $136 million, while Symlin sales rose 24% to $26 million. The company paid Lilly $63 million in profit sharing in 4Q10, down from $75 million. For FY10, Byetta sales fell 16% to $559 million, while Symlin sales were up 6% to $92 million. Cost of goods sold (COGS) in 4Q10 was $14 million (-20%) and selling, general and administrative (SGA) costs were down 23% to $65 million. For FY10, COGS was $62 million (-25%) and SGA was $289 million (-16%).
Financial Reports: Covance

Posted on January 27, 2011 @ 08:04 am

Covance 4Q10

4Q Revenues: $492 million (+1%)

4Q Earnings: $28 million (-32%)

FY Revenues: $1.9 billion (+3%)

FY Earnings: $68 million (-61%)

Comments: Early development revenues grew 9% to $221 million, driven by added revenue from the company's new facilities, acquired in the strategic pact with Sanofi-Aventis; FY10 revenues for the unit were up 6% to $840 million. Late stage development revenues dropped 4% in 4Q10 due to cancellations, delays and other factors; FY10 revenues were +1% ($1.1 billion).
Financial Reports: Lilly

Posted on January 27, 2011 @ 07:53 am

Lilly 4Q10

4Q Revenues: $6.2 billion (+4%)

4Q Earnings: $1.2 billion (+28%)

FY Revenues: $23.1 billion (+6%)

FY Earnings: $5.1 billion (+17%)

Comments: Sales growth was driven by Cymbalta, +19% for 4Q10 ($985 million) and +13% for FY10 ($3.5 billion), Alimta (+9% / $569 million in 4Q 10, and +29% / $2.2 billion in FY10), and the Animal Health unit (+20% / $424 million in 4Q10, and +15% / $1.4 billion for FY10), which grew partly because of an acquisition. Zyprexa sales fell 2% in 4Q10 to $1.3 billion, due to lower demand. Effient sales were $47 million in 4Q10, up from $36.3 million in the previous quarter.
Financial Reports: Novartis

Posted on January 27, 2011 @ 07:37 am

Novartis 4Q10

4Q Revenues: $14.2 billion (+10%)

4Q Earnings: $2.3 billion (-2%)

FY Revenues: $50.6 billion (+14%)

FY Earnings: $10.0 billion (+18%)

Comments: Pharma sales rose 3% for the quarter to $8.0 billion, and 7% for the year to $30.6 billion. The Sandoz generics unit was up 10% in 4Q10 to $2.4 billion and 14% for FY10 ($8.5 billion). The integration of Alcon added $1.8 billion to 4Q10 sales and $2.4 billion for FY10. The biggest growth in the pharma segment came from the Oncology group, with sales of $2.7 billion (+9%) in 4Q10 and $10.0 billion (+11%) in FY10, driven by Gleevec and Tasigna sales.
Financial Reports: Bristol-Myers Squibb

Posted on January 27, 2011 @ 07:22 am

Bristol-Myers Squibb 4Q10

4Q Revenues: $5.1 billion (+2%)

4Q Earnings: $483 million (-94%)*

FY Revenues: $19.5 billion (+4%)

FY Earnings: $3.1 billion (-71%)*

Comments: U.S. sales rose 5% to $3.3 billion in 4Q10, while international sales dropped 5% to $1.8 billion (2% was due to currency exchange rates). 4Q10 Pharma sales were led by Plavix ($1.7 billion / +6%) and Abilify ($700 million / flat). The biggest gains were posted by Sprycel (+42% to $169 million), Baraclude (+25% to $264 million), and Orencia (+20% to $202 million). For the year, Plavix posted sales of $6.7 billion (+8%), while Abilify dropped slightly to $2.6 billion. Avapro/Avalide sales in 4Q10 were down 26% after a large-scale recall.

* Net earnings in 4Q09 and FY09 were boosted by $7.2 billion after-tax gain from spin-off of Mead Johnson Nutrition Co.
FDA Gives RTF to Gilead NDA

Posted on January 26, 2011 @ 08:31 am

Gilead Sciences, Inc. received a “refuse to file” notification from the FDA regarding Gilead’s NDA for the single-tablet regimen of Truvada (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals’ investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults.

The FDA requested additional information with respect to the Chemistry, Manufacturing and Controls (CMC) section of the Truvada/TMC278 NDA submission. The letter stated that the application does not contain sufficient information on the analytical methodology to establish acceptable levels of recently identified degradants related to emtricitabine.

“We are working to validate the methodology to resolve this issue and provide the required information to the FDA,” said Norbert Bischofberger, Ph.D., Gilead's executive vice president, R&D and chief scientific officer. “We expect to be in a position to resubmit the Truvada/TMC278 NDA with the additional requested information prior to the end of the first quarter of this year.”

The FDA has the ability to formally file or refuse to file an application within 60 days of the completion of the submission, which occurred on November 23, 2010.
QPS Acquires Bioserve

Posted on January 26, 2011 @ 08:27 am

QPS, LLC has acquired of a majority stake in Bioserve Clinical Research. Bioserve, a full service phase I CRO headquartered in Hyderabad, India, will be known as QPS-Bioserve India. QPS is a global CRO supporting drug discovery and development, with expertise in preclinical DMPK/toxicology, bioanalytical, translational medicine, and early- and late-stage clinical research.

Bioserve has a 92-bed clinical unit for conducting phase I studies and a bioanalytical lab equipped with multiple LC/MS/MS systems for small molecule bioanalysis. In the past six years, it has conducted more than 500 studies, with numerous product approvals, and has been inspected by the USFDA, UK MHRA, WHO and Indian DCGI.

"This new partnership further expands QPS' global range of linearly integrated services," said Ben Chien, Ph.D., chairman, president and chief executive officer of QPS. "With access to Bioserve's additional resources, our customers will have the heightened benefits of a third more phase I beds, bringing our total to 400, greater bioanalytical capacity, and access to another facility, located in India, with a reputation for outstanding performance and a record of timely approvals. Furthermore, current customers will be reassured to learn that Mr. Suneil Reddy will remain as managing director."
Financial Reports: Gilead Sciences

Posted on January 26, 2011 @ 08:19 am

Gilead Sciences 4Q10

4Q Revenues: $2.0 billion (-1%)

4Q Earnings: $629 million (-22%)

FY Revenues: $7.9 billion (+13%)

FY Earnings: $2.9 billion (+10%)

Comments: The drop in 4Q revenues was due primarily to reduced Tamiflu revenues from the company's royalty agreement with Roche; 4Q10 royalty revenues fell to $21.9 million from $194.1 million. Product sales rose 7% in 4Q10 to $1.9 billion, due mainly to the antiviral franchise. For FY10, product revenues were up 14% to $7.4 billion.
Financial Reports: Abbott

Posted on January 26, 2011 @ 08:11 am

Abbott 4Q10

4Q Revenues: $9.7 billion (+13%)

4Q Earnings: $1.4 billion (-6%)

FY Revenues: $35.2 billion (+14%)

FY Earnings: $4.6 billion (-20%)

Comments: Pharma sales rose 23% for the quarter to $6.0 billion and 21% for the year to $19.9 billion, boosted by the 2010 acquisitions of Solvay and Piramal Healthcare and the strong performance of Humira, which posted 4Q10 sales of $1.9 billion (+13%) and FY10 sales of $6.6 billion (+19%). Humira sales rose 14% in the U.S. to $2.9 billion and jumped 24% overseas to $3.7 billion. Those major acquisitions dragged down Abbott's earnings. Within the earnings announcement, Abbott announced that it will cut 1,900 people from its U.S. pharma workforce. The move follows a September 2010 announcement of 3,000 layoffs, related to the Solvay acquisition. The new move was likely tied into several pipeline failure and is associated with commercial and manufacturing operations.
BioFocus, Lundbeck in Compound Management Pact

Posted on January 26, 2011 @ 07:54 am

BioFocus subsidiary Compound Focus, Inc. has signed a three-year compound management services agreement with Lundbeck Research USA, Inc. Compound Focus will manage Lundbeck’s liquid chemical library collection, distributing screening sets to high throughput screening centers in both the U.S. and Europe. These services will be provided by Compound Focus’ compound management facility in South San Francisco, CA.

“We are pleased to welcome Lundbeck Research USA, Inc. as a new client,” said Scott Snyder, Compound Focus’ General Manager. “Compound Focus continues to attract commercial, government and charitable organizations that see our state of the art automation and compound management experience as a complement to their discovery operations.”
Financial Report: J&J

Posted on January 25, 2011 @ 09:47 am

J&J

4Q Revenues: $15.6 billion (-6%)

4Q Earnings: $1.9 billion (-12%)

FY Revenues: $61.6 billion (-1%)

FY Earnings: $13.3 billion (+9%)

Comments: Worldwide Pharmaceutical sales were $22.4 billion for the year (-1%). Domestic sales were down 4% and international sales increased 4%. Worldwide Consumer sales were $14.6 billion for the year (-8%). Domestic sales of that unit decreased 19% for the year and 29% for 4Q10, while international sales increased 1% for the year but dropped 6% for the quarter. Consumer sales were impacted by numerous recalls of OTC medicines and the suspension of manufacturing at the McNeil Consumer Healthcare facility in Fort Washington, PA. Overall, consumer sales fell $1.2 billion for the year. Worldwide Medical Devices and Diagnostics sales were $24.6 billion for the year (+4%). Results in the quarter included after-tax charges of $922 million for litigation settlements, product liability expense and costs associated with the DePuy ASR Hip recall. Earnings in 2009 included an after-tax restructuring charge of $852 million.

Financial Report: Amgen

Posted on January 25, 2011 @ 09:46 am

Amgen

4Q Revenues: $3.8 billion (+1%)

4Q Earnings: $1.0 billion (+10%)

FY Revenues: $15.1 billion (+3%)

FY Earnings: $4.6 billion (flat)

Comments: U.S. product sales were flat at $2.9 billion in the quarter and included a $65 million unfavorable impact due to U.S. health care reform. International product sales were up 3% to $891 million. Total product sales included a $26 million negative impact of foreign exchange. For the year, U.S. product sales increased 1% to $11.3 billion and included a $198 million unfavorable impact due to U.S. health care reform. International product sales were up 6% to $3.4 billion. Worldwide Aranesp sales were down 2% to $633 million in the quarter and down 6% to $2.5 billion for the year. Sales of Epogen were $591 million in the quarter (-16%), and decreased 2% to $2.5 billion for the year. Combined worldwide Neulasta and Neupogen sales were up 3% to $1.2 billion in the quarter, and up 4% to $4.8 billion for the year. Enbrel sales were $939 million in the quarter (+3%) and $3.5 billion for the year (+1%).

Amgen To Acquire BioVex

Posted on January 25, 2011 @ 09:45 am

Amgen has entered into a definitive agreement to acquire BioVex Group, Inc., a privately held biotechnology company headquartered in Woburn, MA. BioVex is developing OncoVEX(GM-CSF), a novel oncolytic vaccine in Phase III development for the potential treatment of melanoma and head and neck cancer. BioVex will become a wholly owned subsidiary of Amgen. Amgen will pay as much as $1 billion, which includes $425 million in cash at closing and as much as $575 million in additional regulatory and sales milestones. The transaction, subject to customary closing conditions, is expected to close in 1Q11.

“OncoVex has demonstrated encouraging anti-tumor activity in clinical studies for the treatment of melanoma and head and neck cancer, and BioVex is currently enrolling patients into pivotal Phase 3 trials in both indications,” said Roger M. Perlmutter, M.D., Ph.D., Amgen's executive vice president, R&D. “Amgen is particularly excited about joining with BioVex and its talented staff to focus on advancing this late-stage investigational therapy, with the hope of bringing it to market within the next few years.”

“Amgen is ideally positioned to leverage the potential of OncoVEX in multiple solid tumor indications given their impressive oncology franchise and expertise in biologics manufacturing and development,” said Philip Astley-Sparke, chief executive officer of BioVex. “We have a shared vision and commitment to bring novel therapeutics to market and we are looking forward to being able to combine our efforts towards this common goal.”

Executive Moves: Savient Pharmaceuticals

Posted on January 25, 2011 @ 09:43 am

John H. Johnson has been named chief executive officer of Savient Pharmaceuticals, Inc., effective January 31, 2011. Mr. Johnson will also serve as a member of the board of directors. Paul Hamelin, Savient's president and most senior officer will continue in his current role throughout a transition period and will then leave the company to pursue other interests.

Mr. Johnson has significant biotechnology business experience having served as a senior vice president of Eli Lilly and Co. and president of Lilly’s Oncology Business Unit. Additionally, Mr. Johnson was chief executive officer of ImClone Systems and served on ImClone's board of directors until the company was acquired by Lilly in November 2008.

“John is a seasoned and accomplished leader in the biopharmaceutical industry and we are very fortunate to have him join Savient as our CEO,” said Stephen O. Jaeger, chairman of the board. “With the depth of his industry experience, we believe John is the right person to help Savient bring Krystexxa to market and realize this novel drug's full potential, both for our shareholders and those adult patients suffering from chronic gout refractory to conventional therapy. Since securing FDA approval for Krystexxa in September, we have been focused on bringing this exciting new drug to market. John is ideally suited to move us the rest of the way down the road.”

Oxford Licenses Antibody to Sanofi

Posted on January 25, 2011 @ 09:39 am

Sanofi-aventis has acquired an exclusive worldwide license to one of Oxford BioTherapeutics’ (OBT) preclinical antibody programs. Sanofi-aventis will use the licensed antibody, which is directed against a novel target identified by OBT, to develop, manufacture and commercialize antibody drug conjugate (ADC) products for the treatment of cancer. ADC products comprise toxins attached to antibodies, which creates highly targeted therapeutic products that attack tumor cells.

OBT will receive an undisclosed upfront cash payment and is eligible to receive development and regulatory milestone payments, royalties on the worldwide products sales, and performance-based milestones.

“This is the most advanced antibody licensing deal that OBT has signed to date and I am delighted that the target and antibody capabilities that we have built have been recognized by a world leading pharmaceutical company such as Sanofi-aventis,” said Christian Rohlff, chief executive officer of OBT. “Given their expertise and experience in cancer drug development, I am very pleased that a program from our broad preclinical pipeline will be developed by Sanofi-aventis.”

Furiex IBS Drug Gets Fast Track by FDA

Posted on January 24, 2011 @ 08:11 am

Furiex Pharmaceuticals' application for MuDelta, a novel diarrhea-predominant irritable bowel syndrome treatment currently in Phase II, has been granted Fast Track designation by the FDA.

“We are extremely pleased our MuDelta program has been granted Fast Track designation by the FDA,” said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. “The agency recognizes a significant unmet need for new treatment of diarrhea-predominant irritable bowel syndrome. We believe we are making significant progress with the Phase II trial, and this designation allows us to potentially get MuDelta to market faster.”

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of new drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process.
Quintiles Opens Phase I Site in Hyderabad

Posted on January 24, 2011 @ 08:06 am

Quintiles has officially opened its Phase I research facility in Hyderabad, India at Apollo Health City.Constructed in partnership with Apollo Hospitals Group, the new facility will complement Quintiles existing worldwide Phase I facilities. It will provide biopharma customers additional options to complete integrated Phase I programs across multiple geographies at this pivotal stage in medical research, according to a Quintiles statement.

Eddie Caffrey, senior vice president and head of Quintiles Phase I globally, commented, “Sponsors, are under intense pressure to speed delivery of results, ethically, and without compromising patient safety or quality of data. With this new, state of the art, Phase I facility in Hyderabad, India, we will be better able to ally with customers by providing access to large numbers of healthy volunteers for simple studies, in parallel to more complex studies conducted by scientific experts in Europe and the U.S.”

Said Shobana Kamineni, executive director, Apollo Hospitals Group, “We are excited to be working with Quintiles to deliver high quality Phase I studies for international customers in India. Apollo has pioneered the provision of many medical and surgical procedures in India and our mission is to bring healthcare of international standards to within the reach of every individual.”

The team in Hyderabad, under the leadership of executive director Ashish Jain, will work to global standards and procedures and will be connected to sites in London, Uppsala and Kansas through Quintiles' global data network to simplify study management for sponsors and provide integrated information and perspective as early as possible in the development process.

The 86-bed unit will evaluate compounds developed both in India and in other countries. Data capture will be linked electronically to Quintiles other Phase I units in UK, US, and Sweden. Thirty-two beds are equipped with diagnostic cardiology equipment for TQT studies.
Novartis To Acquire Genoptix

Posted on January 24, 2011 @ 07:55 am

Novartis has entered into a definitive merger agreement to acquire Genoptix, Inc. Novartis will commence an all cash tender offer for all outstanding shares of common stock of Genoptix at $25 per share, giving the transaction an equity value of approximately $470 million and an enterprise value of $330 million.

The cash offer price represents a premium of 27% premium over Genoptix' closing price from January 21, 2011. The transaction is expected to close within the first half of 2011.

Genoptix' chief executive officer, Tina S. Nova, Ph.D., stated, "We believe this transaction provides substantial value and liquidity to our stockholders. We are excited about becoming part of the Novartis Molecular Diagnostics (MDx) unit and continuing to enhance the value that we bring to our core community oncologist customers. We share Novartis' strong commitment to transforming patient care, improving health outcomes for patients and enhancing the suite of diagnostic tools for our physician customers."
Executive Moves: Aceto Corp.

Posted on January 24, 2011 @ 07:50 am

Guillaume Saint-Clair has been named to the international pharmaceutical intermediates business for Aceto Corp. Mr. Saint-Clair joined the company in 2001 as a result of the acquisition of Schweizerhall, and has held various management positions, most recently being responsible for managing Aceto's European pharmaceutical intermediates and specialty chemicals businesses since January 2010.

Vincent G. Miata, president of Aceto, remarked, "Guillaume brings many years of experience to this position having a long standing knowledge of the products, customers and suppliers. This new assignment as international vice president, Pharmaceutical Intermediates, is an expansion of his current responsibilities and I look to Guillaume to bring his demonstrated skills to manage our global pharmaceutical intermediates business. I am confident that he will be as successful as he has been in his past roles at Aceto."
inVentiv To Acquire Campbell Alliance

Posted on January 21, 2011 @ 09:26 am

inVentiv Health, Inc. has signed a definitive agreement to acquire Campbell Alliance, a management consulting firm serving the pharmaceutical and biotech industries. The company also recently signed an agreement to purchase i3 from Ingenix.

Paul Meister, executive chairman of inVentiv Health, will serve as chief executive officer. Mr. Meister is founder and chief executive officer of Liberty Lane Partners, LLC, a private equity company that acquired inVentiv in August 2010. Previously, Mr. Meister served as chairman of the board of Thermo Fisher Scientific, Inc. and vice chairman of Fisher Scientific International, Inc. Blane Walter, formerly chief executive officer of inVentiv, will remain on the board of directors as vice chairman and will continue to advise the company's strategy.

With the addition of i3 and Campbell Alliance, inVentiv will realign its organization under three self-operating segments: Clinical, Consulting and Commercial. These will report to Mr. Meister and the company's board. Campbell Alliance’s John and Ann Campbell, chief executive officer and president, respectively, will continue to lead the organization and, along with their management team. Operating under the Campbell Alliance brand, the organization will be based in Raleigh, NC. inVentiv's existing consulting business, Advance Insights, will be folded into Campbell Alliance.

"We are thrilled to welcome both Campbell Alliance and i3 to inVentiv Health," said Mr. Meister. "John and Ann Campbell have built a truly impressive organization that brings together industry expertise and proven methodologies with deep, long-standing client relationships. i3 is among the industry's top CROs, with exceptional clinical talent and resources around the world. As we pursue our strategy of becoming the world's leading provider of best-in-class outsourced solutions to healthcare clients, Campbell Alliance and i3 will serve as critical segments of our business, expanding our ability to meet client needs and driving our future growth."

The financial terms were not disclosed. The acquisition is expected to close in 1Q11.

Covance Genomics Lab Gets CLIA Certification

Posted on January 21, 2011 @ 09:25 am

Covance’s genomics lab in Seattle, WA received Clinical Laboratory Improvement Amendment (CLIA) certification from the State of Washington Department of Health. The lab was licensed in May 2010 and completed the initial CLIA inspection, with no findings, in December 2010. Inspections of CLIA labs is mandated by the Code of Federal Regulations (CFR 42 Part 493.2), and was enacted to ensure consistent, accurate, and reliable clinical test result reporting from laboratories across the country.

The lab supports genomics-based drug development with services including: next generation sequencing, gene expression profiling, genome-wide genotyping, qPCR biomarker assays, microRNA profiling, targeted genotyping, tissue homogenization and nucleic acid extraction, scalable amplification protocols and computational biology & bioinformatics.

In addition to performing CLIA-regulated services, the genomics laboratory meets GLP requirements, having performed multiple GLP protocols and undergone subsequent GLP audits from pharmaceutical clients.

“Obtaining CLIA certification demonstrates to our clients that our laboratory is consistently performing at a very high standard in a regulated environment,” said John Gransee, vice president and general manager, Covance Genomics Laboratory. “This is particularly important when a researcher wants to use the data in discovery to develop a clinical assay. In addition, since every test performed in our laboratory is under the CLIA umbrella, our clients can be confident that they are receiving high quality execution of their experiments regardless of analysis platform.”

OYSTAR Creates New North American Business

Posted on January 21, 2011 @ 09:23 am

OYSTAR GmbH has restructured, creating OYSTAR North America. The new company combines OYSTAR USA, a NJ-based sales operation representing packaging machinery brands manufactured in Europe, as well as packaging equipment manufacturers OYSTAR Packaging Technologies, Davenport, IA; and OYSTAR Jones, Covington, KY.

“We began restructuring one and a half years ago,” said Tom Graf, OYSTAR’s chief executive officer. “From the onset it was our goal to centrally manage individual product and customer groups, and no longer through several subsidiaries. The past financial year clearly shows that this was the right path.”

Barry Shoulders, president of OYSTAR Packaging Technologies, will lead OYSTAR North America. “All of us at OYSTAR North America are excited by this new customer-focused structure that will translate into more complete packaging solutions and stronger partnerships with both customers and vendors,” Mr. Shoulders said.

Other senior management roles within the new company include: Tom Riggins, sales, Gordon Bonfield, transition officer, Jeff Wierenga, service, and Susan Awadalla, finance. Also, Charles Ravalli, current president of OYSTAR USA, will continue in his role. Gordon Bonfield, president of OYSTAR Jones, will oversee the process of combining the three companies into one North American operation.

Genzyme To Expand Bio-Manufacturing Capacity

Posted on January 20, 2011 @ 09:15 am

Genzyme Corp. will build an additional manufacturing plant in Geel, Belgium, to support the long-term growth of Myozyme and Lumizyme for Pompe disease. Construction of the new $336 million plant will include 8,000 liters of production capacity and a complete purification installation, as well as room for additional future capacity expansions. Commercial approvals for the new site are expected to start late 2014.

Genzyme currently produces Myozyme and Lumizyme at an adjacent plant in Geel, where it is increasing production capacity to 12,000 liters with the addition of a third bioreactor. Genzyme is also continuing its 160-liter production in the U.S. for patients with infantile-onset Pompe disease. The investment in Geel is part the company’s program to increase its overall biologics manufacturing capacity four fold. About 150 new jobs will be created with the expansion, bringing the total workforce at the site to approximately 600 people.

“The expansion of our Geel facility is a critical element of our manufacturing strategy and is fundamental to our mission,” said Scott Canute, Genzyme’s president, Global Manufacturing and Corporate Operations. “We are committed to delivering a reliable supply of high quality medicines to our patients. This investment ensures continued supply to our patients in the Pompe community for the long term.”

“Our strong track record of results, the expertise and dedication of our workforce along with the partnership with the authorities in Belgium, have been instrumental in bringing this exciting new investment to our site,” said Piet Houwen, general manager of Genzyme’s Geel manufacturing site.

Evotec, Takeda Enter Multi-Target Pact

Posted on January 20, 2011 @ 09:13 am

Evotec AG has entered into a collaboration with Takeda Cambridge Ltd., to identify small molecule modulators against GPCR and Protease targets to treat various CNS and Metabolic diseases. Financial terms were not disclosed. Evotec will apply its screening platform and GPCR modeling software to identify and validate novel modulators against various targets selected by Takeda.

Dr. Mario Polywka, chief operating officer at Evotec said, “We are proud to be selected by Takeda Cambridge to collaborate on this important project. We have invested significantly in our world leading, hit-identification platform and this alliance further validates the strength of this platform and Evotec's ability to bring value to its partners’ drug discovery efforts. We look forward to working with Takeda Cambridge.”

Dr. Andrew Ayscough, director of chemistry at Takeda Cambridge, said, “We are pleased to have this opportunity to work with Evotec making use of their hit identification platform.”

inVentiv To Acquire Ingenix Clinical Units

Posted on January 20, 2011 @ 09:12 am

inVentiv Health has signed a definitive agreement to acquire the i3 clinical development businesses from Ingenix. The transaction, subject to customary closing conditions, is expected to close in 1H11.

The three businesses will retain the i3 brand and will be aligned with inVentiv’s other clinical development offerings. Glenn Bilawsky will remain chief executive officer of i3. The commercialization, safety, regulatory and late phase service offerings will be launched as Ingenix Life Sciences division, led by Lee Valenta, chief operating officer of Ingenix.

BioClinica, Symbiance Enter Strategic Pact

Posted on January 20, 2011 @ 09:11 am

BioClinica, Inc. has established a strategic partnership with Symbiance Inc., a specialty CRO based in Princeton, NJ. Symbiance focuses on oncology and CNS therapeutics and includes a clinical data management unit, biostatistical analysis, and SAS programming divisions supporting Phase I through IV clinical trials.

“With their therapeutic expertise and knowledge of the clinical trial space, Symbiance is an excellent partner for BioClinica’s offerings. I am confident in the added value this partnership will bring to our mutual clients,” said Peter Benton, president of eClinical Solutions for BioClinica.

“The BioClinica Certified Partner Program saw significant growth in 2010,” he continued. “This growth has continued into the new year with the addition of experienced partners like Symbiance, allowing BioClinica to offer both a best in class product suite and added-value services for our clients. As many CROs seek partners that offer the highest level of technical expertise with global reach and support, they are finding that BioClinica fulfills their needs with the flexibility and capabilities that they require.”

Executive Moves: Cetero Research

Posted on January 20, 2011 @ 09:08 am

Roger N. Hayes, Ph.D., has been appointed president of Bioanalytical Operations at Cetero Research. Dr. Hayes has more than 15 years of scientific experience and leadership in bioanalytical testing, pharmacokinetics and pharmacodynamics, as well as extensive expertise in drug metabolism, high-throughput drug discovery and drug development. He will be based in Cetero’s bioanalytical lab in Houston, TX.

Dr. Hayes joins the company from Schering-Plough Research Institute, part of Merck Research Laboratories, where he served as director of bioanalytical for the last 10 years. He has also held positions with Parke-Davis Pharmaceuticals, now a division of Pfizer, Procter & Gamble, and the University of Nebraska-Lincoln.

“We are honored to have such an accomplished scientist and business leader join us. Cetero is committed to bringing innovation to drug development, and his appointment is one additional step in allowing us to accomplish that goal. Roger has in-depth experience developing bioanalytical methods using mass spectrometry, chromatography and automation, which will allow us to enhance our analytical service offerings to our clients,” said Troy W. McCall, Ph.D., Cetero’s chief executive officer. “In addition, Roger’s vast knowledge of the entire drug development process will help us develop more innovative and effective solutions to help our clients improve efficiencies in their development processes.”


Boehringer To Acquire Amgen's Fremont Site

Posted on January 19, 2011 @ 09:03 am

Amgen and Boehringer Ingelheim have signed an agreement under which Boehringer will acquire the rights to, and the assets of, Amgen's Fremont CA development and manufacturing facility. The 100,000-sq.-ft. manufacturing facility currently has approximately 360 employees and includes a pilot plant and process development labs. The transaction is expected to close in March.

“With great enthusiasm, we look forward to welcoming the Amgen Fremont employees into the Boehringer Ingelheim family of companies,” said Prof. Dr. Wolfram Carius, Boehringer Ingelheim board of managing directors. “The technological expertise at Fremont and the state-of-the-art facility will enable us to further strengthen our global Contract Manufacturing Business including new biological entity process development and manufacturing efforts. We greatly value our relationship with Amgen and are enthusiastic about joining the San Francisco Bay Area biotechnology community and for the opportunity to better serve our current and future contract manufacturing customers.”

“We are pleased to be able to build upon a successful contract manufacturing relationship with Boehringer Ingelheim,” said Dr. Fabrizio Bonanni, Amgen executive vice president of operations. “We look forward to continuing to work closely with them to support Amgen's delivery of safe and effective medicines to patients around the world.”

Famar To Acquire Sanofi-Aventis Madrid Plant

Posted on January 19, 2011 @ 09:02 am

Sanofi-Aventis and Famar have entered an agreement under which Famar will integrate Sanofi’s plant in Madrid, into its network of 11 sites across Europe. The plant produces solid and sterile forms including freeze-drying, and currently supplies more than 50 markets. All employees of the plant will be transferred.

The agreement expands the collaboration between the two companies, which began in 2001 when Famar acquired Sanofi’s plant in L’Aigle, France. Both companies will partner to develop the manufacturing activity of the plant. Sanofi will continue to source certain products from the site through a supply agreement. Famar will invest in developing and expanding the plant’s sterile manufacturing capacities, as well as exploring the external manufacturing market in Spain.

Executive Moves: Norwich Pharmaceuticals

Posted on January 19, 2011 @ 09:00 am

Terence Novak has been appointed president of commercial operations for Norwich Pharmaceuticals. Mr. Novak will provide strategic leadership for the company’s commercial business group that includes sales, marketing and customer service. He will report to chief executive officer of Norwich, Doug Drysdale.

“We are pleased to welcome Terry Novak to Norwich and look forward to his results-oriented approach to business development and customer service,” said Mr. Drysdale. “His expertise within the contract services industry complemented by his energetic commitment to customers will be a strong addition to our leadership team.”

Mr. Novak most recently served as president and chief commercial officer for Patheon, where he successfully achieved an increase in new business while also overseeing five manufacturing facilities. Mr. Novak previously held several senior leadership positions at DSM Pharmaceuticals including senior vice president commercial operations, executive vice president and chief marketing officer, and president and business unit director. He also has more than 15 years of sales and management experience with Bristol-Myers Squibb. Mr. Novak is a member of Contract Pharma’s Editorial Advisory Board.

Click here to learn more about Norwich
Executive Moves: ICON

Posted on January 19, 2011 @ 08:58 am

Dr. Anthony Priestley has been appointed medical director at ICON’s Clinical Pharmacology Unit in Manchester, UK. Dr. Priestley has more than 11 years of experience in pharmaceutical R&D. He joins the company from LCG Bioscience, where he served as medical director and head of clinical research, as well as clinical pharmacologist, responsible for the planning and conduct of all clinical pharmacology operations for projects in reproductive health, neurology, autoimmunity and inflammatory diseases.

“We are delighted to welcome Dr. Priestly to the clinical pharmacology team at our translational medicine unit in Manchester,” said Dr. Thomas Frey, president, ICON Development Solutions. “His appointment is a further demonstration of our commitment to improving early drug development and enhancing our ability to offer sponsors the expertise, specialist procedures and patient populations necessary to more rapidly establish proof of concept.”

Pharmaform To Expand

Posted on January 18, 2011 @ 09:33 am

PharmaForm has hired of several key scientists and invested in equipment for expansion plans in 2011. J. Blair West, Ph.D., has been appointed vice president of Pharmaceutical Operations. Dr. West has more than 20 years of experience as a senior executive and formulation scientist with expertise in several emerging formulation technology platforms, including hot melt extrusion and spray drying. Dr. West was previously employed at Bend Research and Azopharma. Feng Zhang, Ph.D. will be transitioning to senior formulation consultant.

PharmaForm has also expanded its Hot Melt Extrusion (HME) manufacturing capabilities and will be acquiring two new Leistritz Extruders, a ZSE -18 Twin Screw Extruder, as well as a ZSE - 27 Twin Screw Extruder for pilot scale and GMP commercial manufacturing.

“We are extremely pleased to add Blair to our scientific team,” said Gregory M. McKee, president and chief executive officer of PharmaForm. “We believe that Blair, along with our other hires and capital expansion plans will allow PharmaForm to grow significantly in 2011. We would also like to thank Dr. Feng Zhang for his years of dedicated service to the company and wish him great success in his future endeavors.”

Cambrex Zenara Facility Gains EU GMP Approval

Posted on January 18, 2011 @ 09:32 am

Cambrex Corp. has received GMP compliance certification from the Danish Medicines Agency (DKMA) for its manufacturing site in Hyderabad, India, following an audit conducted in October 2010. The DKMA Certificate is accepted by all EU Health Authorities and by authorities of several other countries.

The DKMA certification allows the company to expedite the launch of Nicotine Replacement Therapy (NRT) products in Europe, in addition to offering finished dosage forms of other pharmaceutical products to European customers through an integrated value chain.

Ashok Narasimhan, president of Cambrex Zenara, said, “We are very pleased with the results of the DKMA inspection. This commercially important and significant milestone for Cambrex confirms our commitment to quality in every aspect of operations management and reflects our efforts to sustain and continuously improve quality platforms.”

INC Research Acquires AVOS Life Sciences

Posted on January 18, 2011 @ 09:29 am

INC Research has acquired AVOS Life Sciences. The new division of INC Research, called AVOS Consulting, will provide strategic, operational and financial analysis to life sciences companies. AVOS will operate as a separate division within the company reporting to the chief executive officer, James Ogle.

“We are very pleased to welcome this esteemed group of experts to the INC Research family,” said Mr. Ogle. “The addition of the team members and their proven analytical tools will provide immediate value to our existing customers and significantly contribute to our alliance partnerships efforts.”

Key executives from AVOS — including Neil MacAllister, Keith Ruark, Kathleen Griffin, and David Ewbank — have expertise providing insights into areas such as healthcare trend assessment, business model development, capital allocation, portfolio optimization, accelerated drug development models and pricing and market access.

“Our understanding of the complex healthcare industry and the deep therapeutic foresight within INC Research is a powerful combination to develop new approaches to global drug development and commercialization efforts,” said Mr. MacAllister, president of AVOS Consulting and executive vice president of INC Research. “For example, we work with customers to reach proof of concept faster and at lower cost while carrying these efficiencies over to the later stages of clinical development.”

In addition to providing consulting services, the AVOS team will support INC Research’s Alliance Partnerships program dedicated to the creation and management of strategic clinical delivery alliances.


Executive Moves: QPharma, Inc.

Posted on January 18, 2011 @ 09:26 am

Dave Hammond has joined QPharma, Inc. as vice president of sales and marketing. Mr. Hammond will lead the development and execution of sales efforts including product development and the expansion of the company’s strategic relationships.

Mr. Hammond has more than 20 years of experience in marketing, management and strategic planning. He will leverage his knowledge of the inner workings of pharmaceutical and healthcare organizations to assess and strengthen the compliance efforts of QPharma’s client portfolio.

Prior to joining the company, Mr. Hammond served as vice president of sales and marketing for Porzio Pharmaceutical Services and J. Knipper & Co., Inc., formerly a McKesson Corp. business unit. He has also held senior management positions with Walsh/PMSI and Macmillan Information Services.

Patrick P. Den Boer, QPharma’s chief executive officer, said, “Dave has extensive experience in the management of sales organizations that support the life sciences industry. Through his work for leading pharmaceutical, biotech and medical device companies, he has helped address the industry’s key concerns and is a valuable addition to the QPharma team.”

Catalent Grows Global Sourcing Network

Posted on January 17, 2011 @ 08:52 am

Catalent Pharma Solutions is adding to its global network of sourcing specialists to supply comparator drugs directly from manufacturers in an effort to reduce customer costs and ensure timely initiation and reliability of product supply.

The network’s sourcing specialists will establish a select group of manufacturers and quality assurance professionals to access products, and to identify the most cost-effective options for trial sponsors. Specialists will have access to Catalent’s Clinical Supply Services, from manufacturing to packaging to distributing product directly to the clinical sites.

“Issues pertaining to supply chain management, such as reliability, pricing and security, often threaten to undermine the success of a clinical study,” said Frank Lis, vice president and general manager, Clinical Supply Services, Catalent Pharma Solutions. “In assembling this global network of comparator sourcing specialists, we aim to provide our clinical trials customers with the highest-quality supply, as well as competitive prices, fast procurement and a minimized risk of project delay and counterfeit products.”

Click here to learn more about Catalent.
Abbott Withdraws MAA for Ozespa

Posted on January 17, 2011 @ 08:51 am

Abbott Laboratories has withdrawn its centralized marketing authorization application with Europe’s EMA for Ozespa, briakinumab, 100 mg solution for injection, for the treatment of moderate to severe chronic plaque psoriasis in adults who failed to respond to, or who are intolerant to other systemic therapies.

At the time of the withdrawal it was under review by the agency's Committee for Medicinal Products for Human Use (CHMP). According to a company statement, the decision was based on the views from day 80 assessment reports that additional new data and analyses would be required for a favorable opinion, which could not be generated within the timeframe allowed in the centralized procedure.

Ecron Acunova Expands Clinical Research Center

Posted on January 17, 2011 @ 08:49 am

Ecron Acunova has expanded its Mangalore Clinical Pharmacology Unit to an 80-bed facility in order to meet growing demand for pharmacokinetic and pharmacodynamic studies. The total bed capacity at research centers in Mangalore, Manipal and Bangalore is now 176 units. The company has also added new spectrometers.

Mr. D.A. Prasanna, chairman and managing director, said, “In a short period of five years, over 250 Phase I studies and over 70 late phase studies have been conducted taking the company to top three position among nearly 100 CROs in India. Ecron Acunova offers solutions according to our clients' needs without compromising quality. This capacity expansion will help us to serve our clients at a faster pace.”

Executive Moves: Tapemark

Posted on January 17, 2011 @ 08:47 am

Pat Mork has been promoted to vice president of human resources at Tapemark. In her previous role as director of human resources, she was responsible for the successful oversight of training for Tapemark employees, supported by a three-year Minnesota Job Skills Partnership grant. Additionally she led the establishment of an employee-driven wellness committee.

Ms. Mork joined the company in 1997 as an HR consultant with a specialty in recruiting. Her previous experience includes management support for benefits, recruiting, training, and organizational development for a large, multi-location organization.

ICON Acquires Oxford Outcomes

Posted on January 14, 2011 @ 08:59 am

ICON has acquired Oxford Outcomes, an international health outcomes consultancy, expanding its late phase and outcomes research services. Elizabeth Thiele, formerly ICON’s executive vice president of business development, has been appointed president of this service unit.

Based in Oxford, UK, with offices in the U.S. and Canada, Oxford Outcomes provides services in the areas of patient reported outcomes (PRO), health economics, epidemiology and translation and linguistic validation.

Peter Gray, chief executive officer of ICON, said, “The biopharmaceutical industry and regulators are more than ever before using post-marketing studies to demonstrate efficacy and safety, as well as demonstrating the economic value of products. Oxford Outcomes has grown to become a leader in its field and brings to ICON a wealth of expertise in the fields of health economics, outcomes research and epidemiology and a strong reputation for excellent client service.”

“We are really excited about joining ICON,” said Paul Quarterman, group managing director of Oxford Outcomes. “The demand for health outcomes services has never been greater and merging with ICON gives us the opportunity to effectively integrate clinical development with outcomes research on a global scale. Blending the knowledge and expertise from both companies will lead to powerful, market-leading client solutions, both in the post-marketing arena and earlier in the development process.”

ShangPharma Opens Pilot Plant Facility

Posted on January 14, 2011 @ 08:54 am

ShangPharma Corp. began operations on the initial phase of production at its new pharmaceutical development and cGMP manufacturing facility in Fengxian, China. The facility, a wholly owned subsidiary of ShangPharma, will operate as China Gateway Pharmaceutical Development Co. Ltd., and will allow the company to expand its service offering to include process R&D, formulation R&D, analytical method development and validation, and cGMP manufacturing of intermediates and APIs.

With the newly added capacity, the company will be able to support projects through Phase II and into Phase III, and can further expand its manufacturing facilities based on demand for commercial manufacturing of FDA- or EMEA-approved drugs.

The facility includes a pilot plant that has six separate bays with reactor capacities ranging from 200 to 3,000 liters and other specialty bays with reactor capacities ranging from 50 to 2000 liters for high temperature, cryogenics, highly toxic and pressurized reactions, including hydrogenation. There are also two cleanroom suites rated at Class 100,000 for isolation, 10 kilo-labs suites for both non-cGMP and cGMP manufacturing, as well as a large R&D lab for analytical, formulation and process development activities. Part of the new facility is dedicated to analytical support, and testing of raw materials, intermediates and final products will also be carried out at the site.

CRI Acquires Lifetree

Posted on January 13, 2011 @ 09:07 am

CRI Worldwide has completed its acquisition of Lifetree Clinical Research. The acquisition combines CRI’s position in psychiatry and patient population studies with Lifetree’s expertise in pain management and human abuse liability, as well as performing complex studies in early-stage clinical research.

The acquisition expands CRI’s clinical pharmacology capacity to more than 120 beds. The combined organization will provide a broad range of psychiatry and neurology research products and services at three research sites located in NJ, PA, and UT.

Lifetree’s founders, Alice Jackson, RN and Lynn Webster, M.D., will remain with the company and continue to lead operations in UT, while becoming part of the combined organization’s senior management and clinical operations teams.

"As they seek to improve returns on research investments, drug companies and CROs increasingly need clinical research sites that can offer highly specialized services and access to patient populations," said Jeffrey Kinell, president and chief executive officer of the combined organization. "I am confident that the clinical and operational strength of the CRI and Lifetree teams will provide our clients with the highest levels of quality and efficiency."

Ms. Jackson, president, Lifetree Clinical Research, added, "As clients seek more value for their research spending, the focus and commitment of the combined CRI and Lifetree teams offers a level of service that cannot be matched. There is a pedigree of excellence at both CRI and Lifetree and the opportunity to offer more resources to our clients is exciting. CRI will provide Lifetree with both the operational and financial resources to continue to do what we do best and to expand the capabilities of the Lifetree Center of Neuroscience Research."

RecipharmCobra’s ORT-VACT Delivery Shows Promise

Posted on January 13, 2011 @ 09:04 am

RecipharmCobra Biologics, in collaboration with the Royal Holloway, University of London and the Universita Cattolica del Sacro Cuore of Rome, Italy, has released the results of a study to develop an oral vaccine against tuberculosis.

The study showed that the orally delivered ORT-VAC DNA vaccine produced higher immune responses in mice than the injected DNA vaccine, resulting in a reduction of the TB bacterium Mycobacterium tuberculosis in the lungs of immunized mice. Previous studies in mice using ORT-VAC to deliver protein vaccines have protected against bubonic plague and anthrax.

RecipharmCobra’s ORT-VAC employs live Salmonella bacteria to deliver a TB vaccine orally. The Salmonella bacteria are modified so as not to cause disease. The vaccine is a DNA vaccine, where a gene from a disease-causing microorganism is used to stimulate an immune response.

Simon Saxby, vice resident of Biologics at RecipharmCobra, said, “Using an attenuated bacterium to deliver vaccines orally is a very exciting new area, and the delivery of DNA vaccines has been particularly challenging. The study illustrates the versatility of RecipharmCobra’s ORT-VAC technology to provide a delivery route for needle-free administration of a DNA vaccine. A vaccine based on ORT-VAC could be inexpensive to produce, simple to distribute and easy to administer, which is essential for tackling the disease in developing countries.

Executive Moves: Harmony Labs

Posted on January 13, 2011 @ 09:01 am

Dr. Charles Gray has been appointed vice president of R&D at Harmony Labs. Dr. Gray will lead the formulation and analytical teams in the support of Harmony’s Rx, OTC, Animal Health and Cosmetic market segments. Dr. Gray most recently served as executive director for product development at GlaxoSmithKline/Stiefel Laboratories. Dr. Gray also served as director of regulatory affairs at Stiefel Laboratories.

Dr. Gray succeeds John Maloney, who has been appointed vice president of Rx product and process development. Dr. Maloney has expertise in drug development, process scale-up and on-going production support. He will work to advance Harmony’s Rx product development, technical and analytical services, and manufacturing offerings. Prior to joining the company four years ago, Dr. Maloney held R&D leadership positions at Taro Pharmaceuticals and Alpharma.

Evotec Earns Boehringer Milestone

Posted on January 13, 2011 @ 08:59 am

Evotec AG has reached a milestone triggering a $2.6 million payment in its research alliance with Boehringer Ingelheim. The milestone was for the transition of an oncology program into lead optimization.

Dr. Mario Polywka, chief operating officer of Evotec, said, "This is the 11th milestone achieved as part of this alliance with Boehringer Ingelheim and the second against an oncology target. We continue to enjoy a very rich scientific partnership with Boehringer Ingelheim and look forward to continued success through our joint project teams in the coming years."

In 2004, the two companies entered into a multi-year, multi-target drug discovery alliance to jointly identify and develop preclinical candidates for the treatment of various disease areas including CNS, inflammation, cardiometabolic and respiratory diseases.

Intertek Acquires American Analytical Chemistry Labs

Posted on January 12, 2011 @ 09:30 am

Intertek, a provider of quality and safety solutions for a wide range of industries around the world, has acquired American Analytical Chemistry Laboratories Corp. (AACL). AACL provides analytical testing and research services to companies engaged in the development, production and distribution of food, functional foods, drinks and cosmetics, nutritional supplements, nutraceuticals, pharmaceuticals and biopharmaceuticals. Its chemical testing services monitor for the presence of residues, pesticides and antibiotics in order for companies to comply with regulations and quality and health standards.

The acquisition of AACL positions Intertek to meet the growing testing, analytics and certification needs of companies producing, manufacturing and distributing food and functional food products.

“Intertek’s acquisition of AACL broadens our extensive capabilities, including quality, risk and safety assessments, commodity testing and analytics, inspections, auditing and certification,” said Jochen Zoller, president of Intertek Food Services. “As the multi-billion dollar functional foods industry continues to experience steady growth, we are well positioned to meet the increased testing and certification needs of our customers.”

DSM, Codexis Enter Enzyme Supply Pact

Posted on January 12, 2011 @ 09:28 am

DSM Pharmaceutical Products and Codexis, Inc. have signed an enzyme supply agreement granting DSM rights to use Codexis' custom biocatalysts and services. Codexis will also supply enzymes for commercialization of sustainable enzyme-based pharmaceutical manufacturing routes developed by DSM's InnoSyn route scouting services.

Codexis technology enables development of new efficient manufacturing processes for APIs and intermediates, helping to reduce costs and environmental waste. DSM’s InnoSyn route scouting team provides solutions by integrating enzyme technology with the full range of synthetic methods such as homogeneous catalysis, modern organic synthesis and continuous chemistry. According to the company, the new routes result in increased efficiency of the manufacturing processes while reducing cost and environmental impact.

"Codexis has a proven track record over nearly 10 years in bringing innovation and manufacturing efficiency to our partners," said Joseph Sarret, M.D., president, Codexis Pharmaceutical Services & Enzyme Products. "We are pleased to collaborate with DSM in the field of biocatalysis to enable cost-effective manufacturing process at commercial scale."

Oliver May, Ph.D., corporate scientist and business manager for DSM's InnoSyn route scouting services, said, "One important success factor for implementing enzymatic routes is access to a diverse range of biocatalysts. DSM is continuously expanding its unique enzyme collection of more than 3,000 enzymes by in-house developments as well as innovative partnering models. We are very pleased to collaborate with Codexis whose expertise in enzyme development perfectly matches with DSM's capabilities to identify, develop and implement efficient enzymatic routes."

Merck, PAREXEL Form Strategic Biosimilar Alliance

Posted on January 12, 2011 @ 09:26 am

Merck and PAREXEL International Corp. have entered into an alliance under which PAREXEL will provide access to global clinical development services for designated biosimilar candidates to Merck BioVentures, a division of Merck.

PAREXEL will provide access to regulatory strategy and clinical development planning capabilities for the development of various classes of biosimilars across multiple therapeutic areas, including exclusivity for certain candidates. The agreement also provides for the establishment of a dedicated Merck BioVentures unit within the PAREXEL organization.

"PAREXEL has extensive, industry-leading experience with biosimilar development, and we truly understand the scientific complexities, and regulatory pathways involved," said Josef von Rickenbach, chairman and chief executive officer of PAREXEL. "We are committed to working with Merck BioVentures to assist in advancing its biosimilar portfolio in this rapidly developing market segment for the benefit of patients worldwide."

"Through this agreement, Merck BioVentures has secured broad strategic access to PAREXEL's proven biosimilar clinical development experience," said Michael Kamarck, president of Merck BioVentures. "This agreement positions Merck BioVentures for success with an industry leading partner that has the expertise and resources to conduct clinical development of our diverse portfolio of candidates to allow timely delivery of products to the marketplace."

Sun European Partners Acquires NextPharma

Posted on January 12, 2011 @ 09:24 am

An affiliate of Sun European Partners, LLP has entered into an agreement to acquire NextPharma Technologies Holding Ltd., a global provider of contract manufacturing, product development, clinical trials and logistics services to the pharmaceutical and biotechnology industry.

Headquartered in Surrey, UK, NextPharma provides a range of services from drug development to manufacturing and distribution supply chain. The company has seven manufacturing facilities, seven product development centers and six temperature-controlled storage and distribution sites across Europe and the
U.S.

Bill Wedlake, chief executive officer of NextPharma said: “For many years we have worked closely with our customers to develop a full range of integrated pharmaceutical development, manufacturing and logistics services to provide flexibility and confidence through high levels of quality and customer service. We are excited to work with Sun European Partners to continue to grow the company and to expand into innovative new technologies and markets.”

Matthias Gundlach, vice president of Sun European Partners added, “The pharmaceutical industry is increasingly using drug development and manufacturing outsourcing. NextPharma, with its strong track record, reputation and state of the art facilities, is well positioned to capitalise on these trends. We see significant opportunity to grow the business both organically and by acquisitions and look forward to working with management to achieve this potential.”

Xcellerex Earns Productivity Excellence Award

Posted on January 12, 2011 @ 09:14 am

Xcellerex, Inc. has received the Invensys Operations Management OPEN award for “innovative use of Invensys products and solutions to generate considerable business results” in four Operational Excellence categories. Invensys is a global provider of technology systems, software solutions and consulting services.

Xcellerex was awarded for Productivity Excellence using several Invensys solutions, including Wonderware System Platform, InBatch, InTouch HMI, Historian Software and Historian Client products. According to Invensys, the Xcellerex technology platform allows manufacturing capacity to be deployed rapidly, flexibly and at significantly reduced cost compared with conventional technology.

“Xcellerex has embraced the groundbreaking capabilities inherent within the Wonderware System Platform and InBatch products, leveraging that power to augment the value delivered to their customers,” said Darren Kline, director of marketing and business development at Invensys. “We are proud that this partnership has helped Xcellerex uniquely blend the benefits of Wonderware software along with their own advanced technology to redefine Productivity Excellence.”

Ken Clapp, Xcellerex senior director of marketing and product management, commented, “Our automation team does a tremendous job integrating complex bioprocess operations in our facility and for our clients. Our bioprocess automation simplifies life for our clients, and also gives them greater control and peace-of-mind in running their operations. To be recognized by an industry leader like Invensys is a great honor for us.”

Executive Moves: PharmaZell GmbH

Posted on January 12, 2011 @ 09:14 am

Tracey Burr, Ph.D., has been appointed chief technology officer for PharmaZell GmbH. Dr. Burr is responsible for R&D activities for all of the company’s sites. She will report to Dr. Wolfgang Burger, managing partner of PharmaZell.

Dr. Burr has many years of experience in various R&D executive positions in the field of APIs. Dr. Burr will use her experience, technical and leadership skills to help PharmaZell further strengthen and expand its position as a CMO in the pharmaceutical industry.

"I am very pleased that we were able to get Tracey Burr on our team. Tracey’s capabilities and personality as well as her experience in the pharmaceutical industry make her a great asset to the company," said Dr. Burger, managing partner of PharmaZell.

Lilly, Boehringer Ingelheim In Diabetes Alliance

Posted on January 11, 2011 @ 09:22 am

Eli Lilly and Co. and Boehringer Ingelheim entered a global agreement to jointly develop and commercialize a portfolio of diabetes compounds currently in mid- and late-stage development. The portfolio includes Boehringer's two oral diabetes agents, linagliptin and BI10773, and Lilly's two basal insulin analogues, LY2605541 and LY2963016, with the option to co-develop and commercialize Lilly's anti-TGF-beta monoclonal antibody.

Linagliptin is being developed as an oral once-daily tablet for the treatment of Type 2 diabetes and is currently under review in the U.S., Europe and Japan. Boehringer's BI10773 began enrollment in Phase III trials last year. It belongs to a new class of diabetes compounds that block tubular reabsorption of glucose in the kidney.

Lilly's two basal insulin analogue candidates, LY2605541 and LY2963016 are expected to enter Phase III development in 2011. The agreement also includes an option for Boehringer to co-develop and commercialize another Lilly diabetes molecule, an anti-TGF-beta monoclonal antibody, which is currently in Phase II trials in patients with diabetes with chronic kidney disease.

Lilly will make an initial one-time payment of $387 million. Boehringer will be eligible to receive as much as $807 million in success-based milestones for linagliptin and BI10773. Lilly will be eligible to receive as much as $650 million in success-based regulatory milestones on its two basal analogue insulins. If Boehringer opts-in to the Phase III development and potential commercialization of the anti-TGF-beta monoclonal antibody, Lilly would be eligible to receive as much as $525 million in success-based milestone payments. The companies will share ongoing development costs and upon successful regulatory approval of any product resulting from the alliance, the companies will share commercialization costs and gross margin.


Elite Pharma, Hi-Tech Pharmacal Sign Supply Pact

Posted on January 11, 2011 @ 09:20 am

Elite Pharmaceuticals, Inc. and Hi-Tech Pharmacal Co., Inc. have entered into an agreement under which Elite will develop an intermediate for Hi-Tech for a generic version of a prescription product. Elite will develop an intermediate product that Hi-Tech will then incorporate into a final product. Hi-Tech will be responsible for filing the ANDA.

Upon approval of the ANDA, Elite will manufacture the intermediate
product and Hi-Tech will manufacture the final product and will be
responsible for marketing and sales. Elite will receive milestone payments for the development work and upon commercialization, will receive payment for the manufacturing of the intermediate product and a percentage of the profits generated from sales.

PPD Establishes Biotherapeutics JV

Posted on January 11, 2011 @ 09:19 am

PPD, Inc. has established a joint venture with Taijitu Biologics Ltd. (TBL), named BioDuro Biologics, to discover novel biotherapeutics. BioDuro Biologics aims to develop and commercialize an innovative technology platform for the discovery of first- and best-in-class monoclonal antibody therapies in collaboration with MAB Discovery GmbH in Munich, Germany. The JV will then provide drug discovery services based on this technology platform to global biopharma companies.

Based in Singapore, BioDuro Biologics allows PPD to take advantage of the growth and success of biotherapeutics and creates opportunities for BioDuro, PPD’s drug discovery business, to provide additional services for antibodies discovered using the new technology platform. PPD owns a majority stake in the JV and has committed to invest $25 million.

“Developing a best-in-class, innovative technology platform for the discovery of monoclonal antibodies allows us to continue to deliver highly valued discovery services for our clients in the growing area of large molecule drug discovery,” said Lee Babiss, Ph.D., executive vice president of global laboratory services for PPD. “As PPD continues to invest in drug discovery, we are well-positioned to deliver high quality, innovative drug discovery technologies and expertise that advance our clients’ compounds more quickly and cost efficiently.”

Stephan Fischer, Ph.D., founder and co-owner of TBL and MAB Discovery GmbH, will serve as a member of BioDuro Biologics’ board of directors and will lead the development of the technology platform, which is expected to be completed by mid-2011.

DSM to Manufacture BiAqua’s Ferritin

Posted on January 11, 2011 @ 09:17 am

DSM BioSolutions, Royal DSM's microbial fermentation contract manufacturing business, and BiAqua B.V., a bio-based solutions provider for serious water contamination issues, have entered into an agreement for strain development, process development and production of "BiAqua Ferritin" for BiAqua's core technology to address bio-fouling and arsenic contamination in the water sector.

DSM has successfully started strain and process development of BiAqua Ferritin at its process development facility in Delft, The Netherlands and will soon begin scale-up and manufacturing at its microbial fermentation biotech facility in Capua, Italy. The BiAqua Ferritin will be used for BiAqua water contamination studies in collaboration with water companies and consumers worldwide to reduce bacterial and arsenic contamination.

Nityen Lal, managing director of BiAqua, said, "DSM has assembled a first class team to help us drastically optimize the cost of production on the basis of their expertise, proprietary tools and technology. This should enable BiAqua to offer an affordable bio-based solution to the market in the short term."

Villaume Kal, vice president of DSM BioSolutions said, "We are delighted to work with BiAqua, an innovative and progressive company developing bio-based solutions to worldwide water contamination issues. Our technology, operational excellence and outstanding regulatory compliance record allows us to serve this important customer and to develop and manufacture their Ferritin product."

Financial terms were not disclosed.

Executive Moves: Camargo Pharmaceutical Services

Posted on January 11, 2011 @ 09:16 am

Ray Dawkins, M.D., has been appointed chief medical officer at Camargo Pharmaceutical Services. Dr. Dawkins has more than 25 years of clinical research and pharmaceutical development experience including Phase I, first-in-human and biologics. He also has expertise in Phase I-III clinical trial design, drug safety reporting, medical writing and international regulatory interaction and submissions.

“The addition of Dr. Dawkins will expand our services to include so-called bio-betters - biologics that are improved over the reference products,” said Ken Phelps, president and chief executive officer of Camargo. “We use our proven knowledge of how to improve small molecule drugs to improve biologic-based drugs. In a sense, we’re just living up to our brand and teaching a new dog a new trick.”

Prior to joining the company, Dr. Dawkins was an executive medical director of medical affairs at Paragon Biomedical in Cary, NC. He was also the senior medical director of clinical development at Talecris Biotherapeutics in Research Triangle Park, NC. In previous positions, Dr. Dawkins was responsible for planning, implementing, leading and evaluating global projects, as well as business development and product acquisition activities.

Galapagos Achieves GSK Milestone

Posted on January 11, 2011 @ 09:14 am

Galapagos NV has completed first-in-human trials with GLPG0555 in healthy volunteers in its arthritis alliance with GlaxoSmithKline. Galapagos also initiated Phase I development for a second drug candidate, GLPG0778, triggering a milestone payment of $9.6 million.

Initial Phase I results for GLPG0555 showed no changes in vital signs and lab parameters for dosing up to 14 consecutive days in healthy volunteers and the drug was well tolerated with no severe adverse events reported. In December 2010, Galapagos initiated a first-in-human trial for GLPG0778 in healthy volunteers. This drug candidate, which inhibits kinase target GT623, has demonstrated excellent activity and safety in biochemical and animal models, and has successfully completed preclinical development.

"We are pleased to report progress on candidate drugs in our arthritis alliance with GSK," said Onno van de Stolpe, chief executive officer of Galapagos. "Today's announcement increases our clinical rheumatoid arthritis portfolio to four candidate drugs, with a balanced risk profile of known and novel modes of action."

AMT To Supply Gene Therapy for Trials

Posted on January 10, 2011 @ 09:26 am

Amsterdam Molecular Therapeutics (AMT) has entered into an agreement with Institut Pasteur, and a group of French research institutes (the "Consortium") to support clinical development of a gene therapy to treat Sanfilippo B., a rare genetic disease affecting newborn children that leads to progressive neuronal degeneration and death.

Institut Pasteur will lead the development program and sponsor the initial Phase I/II study of a gene therapy to replace an enzyme (alpha-N-acetylglucosaminidase) that is missing in brain cells of SanfilippoB patients. This enzyme is specifically required for the degradation of heparan sulfate glycosaminoglycans (GAGs), essential carbohydrate molecules used to build tissue. The accumulation of incompletely degraded GAG molecules triggers a cascade of pathological events leading to neuronal dysfunction and death.

AMT will manufacture and supply the adeno-associated viral 5 (AAV5) gene therapy product to the Consortium. The overall manufacturing contract is valued at $2.3 million. If the Phase I/II study is successful, AMT will have an option to acquire full commercial rights for the program. The study is scheduled to begin before 2013. AMT has a cGMP-licensed, 375-sq.-m. manufacturing facility to produce its AAV vectors for gene therapy products.

"This partnership leverage's AMT's proven expertise in cGMP manufacturing of gene therapy products and our experience in progressing these products through clinical development and the regulatory processes needed for successful commercialization," said Jorn Aldag, chief executive officer of AMT. "In addition, we will have an option to acquire full commercial rights for the program on completion of the Phase I/II study, which supports our strategy to build a pipeline of orphan and ultra-orphan indications."

Muriel Eliaszewicz, medical director of Institut Pasteur, said, "AMT is one of the only companies in the world that has a proven ability in manufacturing cGMP quality gene therapy products, not only in batches sufficient for clinical development but also in support of a potential regulatory approval. We are delighted that we now have the ability to commence the difficult process of developing a cure for patients with this very challenging disease.”

Epizyme, GSK Form Epigenetic Alliance

Posted on January 10, 2011 @ 09:24 am

Epizyme and GlaxoSmithKline have entered a strategic alliance to develop novel small molecule therapeutics targeting histone methyltransferases (HMTs), an important class of epigenetic enzymes, for the treatment of cancer and other diseases.

Epizyme will use its HMT discovery platform, chemical library, and expertise to discover and develop HMT therapeutics against the set of targets to be included in the collaboration. Epizyme will receive an upfront payment of $20 million, as well as research funding. Epizyme is eligible to receive more than $630 million in total milestone payments if products for all targets in the collaboration are commercialized, as well as royalties on sales. Epizyme will be primarily responsible for research up to development candidate selection, and GSK will be responsible for development and commercialization.

Robert Gould, Ph.D., chief executive officer and president of Epizyme, said, “Epizyme’s mission is to develop personalized therapeutics for genetically-defined patients based on our understanding of the driving role played by many HMTs in human disease. We are excited to be working with GSK. This collaboration validates our unique discovery platform and the targeted approach we bring to HMT therapeutics.”

BMS, Pharmasset in HCV Pact

Posted on January 10, 2011 @ 09:22 am

Bristol-Myers Squibb and Pharmasset have entered into a clinical collaboration agreement to evaluate BMS-790052, a NS5A replication complex inhibitor, in combination with PSI-7977, Pharmasset’s nucleotide polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV).

The study will evaluate the potential to achieve sustained viral response 24 weeks post treatment with an oral, once-daily treatment regimen in patients across HCV genotypes. Specifically, the study will assess the safety, pharmacokinetics and pharmacodynamics of BMS-790052 in combination with PSI-7977, with and without ribavirin, in treatment-naïve patients chronically infected with HCV genotypes 1, 2, and 3. The study is planned for 1H11.

“Bristol-Myers Squibb is committed to the goal of helping patients prevail over hepatitis C by investigating multiple therapeutic platforms,” said Brian Daniels, senior vice president, development at BMS. “We are pleased to partner with Pharmasset on this important study to advance the scientific understanding of the potential for an all-oral regimen to treat hepatitis C. Conducting this study highlights our ability to collaborate with other companies to develop innovative combination therapies in areas of high unmet need.”

”We are excited to be working with BMS and to be investigating PSI-7977 with a different class of direct acting antivirals,” stated Michelle Berrey, MD, MPH, chief medical officer. “This collaboration represents one of many approaches we are pursuing with our portfolio of nucleoside/tide analogs that include both interferon free and interferon sparing regimens. We believe the development of an all oral treatment regimen represents an important evolution in the treatment of HCV.”

Savient Provides Manufacturing Plans for Krystexxa

Posted on January 7, 2011 @ 09:36 am

Savient Pharmaceuticals provided an update on its business activities related to the U.S. launch and commercialization of Krystexxa, a PEGylated uric acid specific enzyme for the treatment of chronic gout. The company is planning to launch the drug in 1Q11. For the launch of Krystexxa, Savient has inventory of the drug at its third party logistics warehouse in the U.S., which the company believes to be adequate to supply market demand through 1Q12.

The company’s third party contract manufacturing organizations in Israel and Indianapolis, IN began regularly scheduled commercial manufacturing to build inventory of pegloticase and Krystexxa. The third party CMO in Israel and Merck Biomanufacturing Network, which Savient is working to qualify as a secondary contract manufacturer, have experienced some batch failures based on one manufacturing specification. The company believes these batch failures are within normal industry failure rates when beginning the commercial manufacture of a biologic. With the help of an outside manufacturing and quality consulting firm, Savient has completed a review of these batch failures and believes it has identified the cause of the problem at both the company's third party CMO in Israel and Merck, and has begun the process of implementing remediation steps.

Savient plans to repeat its validation campaign batches at Merck in 2011, which the company expects will result in additional costs of approximately $9 to $10 million over a two-year period.

Cambrex Zenara Supplies Product for India Nicorette Launch

Posted on January 7, 2011 @ 09:35 am

Cambrex Zenara is supplying product for Johnson & Johnson Ltd.'s launch of smoking cessation drug Nicorette in India. The Nicorette product is being manufactured and packaged by Cambrex Zenara in its Hyderabad, India facility.

"Nicotine Replacement Therapeutics represent an important part of our product portfolio," said Steven M. Klosk, president and chief executive officer of Cambrex. "It is estimated that India has over 270 million tobacco users, second only to China, and we are proud to supply product for Johnson & Johnson's launch of Nicorette in this market."

Ashok Narasimhan, president of Cambrex Zenara said, "Being selected by Johnson & Johnson as their manufacturing partner is a testament to Cambrex Zenara's ability to supply product for a well-known brand to a very large market. This demonstrates our commitment to provide high quality, affordable solutions for smoking cessation."

Executive Moves: AVI BioPharma

Posted on January 7, 2011 @ 09:33 am

Effie Toshav, J.D., has been appointed senior vice president and general counsel at AVI BioPharma, effective January 10th. Ms. Toshav has considerable industry-specific legal, corporate development and strategic experience. Most recently, she was a partner in the life sciences group at Wilson Sonsini Goodrich and Rosati (WSGR), where she served as outside counsel to a large number of prominent biotech companies advising management teams on a wide range of business and legal matters.

Prior to WSGR, she served as general counsel and a member of the management team at GlycoFi, where she was responsible for all legal and general corporate matters.

"Effie's talent, experience and skills add considerable breadth and depth to the management team, as does her deep expertise in the key areas of corporate development and intellectual property, as we navigate this pivotal point in the company's development," said Chris Garabedian, AVI's chief executive officer and president. "We are excited to have Effie join the team and look forward to her contribution."

Emerald BioStructures Achieves Second UCB Milestone

Posted on January 7, 2011 @ 09:31 am

Emerald BioStructures has successfully achieved the second milestone in its collaboration with UCB on the structure-based discovery of small molecule modulators of undisclosed targets. Together, the two companies have solved high-resolution X-ray crystallographic structures of multiple targets, and identified unique lead series of small molecules.

“Emerald and UCB initiated their collaboration partnership in January of 2009, and over the last 24 months, have made significant progress,” said Neil Weir, senior vice president of research at UCB. “We are very impressed with Emerald’s ability to consistently deliver structural insights in a fast-paced and exciting project that requires continuous innovation.”

“In this collaborative effort, we’ve identified multiple modulators of protein structure and function,” said Alex Burgin, chief operating officer of Emerald BioStructures. “We look forward to supporting UCB in their structure-guided design and selection of clinical candidates over the next 24 months.”

Additionally, Emerald and UCB have expanded their collaboration in structure-based drug discovery. “The expansion of our UCB collaboration is an important demonstration of the confidence that UCB has in the Emerald team, and is a clear validation of our fragment-based X-ray structure technology, especially when applied to challenging targets,” said Lance Stewart, chief executive officer of Emerald BioStructures.Financial terms of the pact were not disclosed.

AMRI Consolidates Drug Discovery Platform

Posted on January 6, 2011 @ 09:05 am

AMRI has merged its Discovery R&D and Discovery Chemistry departments to form a Global Drug Discovery organization. Bruce J. Sargent, Ph.D., has been appointed senior vice president of the new organization. The company is combining its discovery chemistry and biology functions into a single unit across locations worldwide.

“AMRI has been involved in numerous integrated discovery projects for a number of years,” said Dr. Sargent. “Our experience in successfully developing projects both internally and in collaboration with customers stands as a testament to our ability to provide a high level of project management, well developed and tested solutions, and added-value to our customers.”

“Customers are increasingly seeking out CROs that can provide them with fully integrated solutions in their pursuit to diminish costs and project timelines, while still desiring to maintain a high level of quality and value,” said chairman, chief executive officer and president Thomas E. D’Ambra, Ph.D. “We believe that combining all of our discovery capabilities in biology and discovery chemistry under the direction of Dr. Sargent will further enhance AMRI’s ability to generate significant value for our customers and stakeholders.”

Seattle Genetics, Pfizer Enter ADC Pact

Posted on January 6, 2011 @ 09:03 am

Seattle Genetics has entered into a collaboration agreement with Pfizer, under which Pfizer will pay $8 million upfront for rights to use Seattle Genetics’ antibody-drug conjugate (ADC) technology with antibodies to a single oncology target. ADCs are monoclonal antibodies that selectively deliver potent anti-cancer agents to tumor cells.

“This collaboration reflects the increasing value of our ADC technology and strong interest in its potential among leaders in the drug development community,” said Eric L. Dobmeier, chief business officer of Seattle Genetics. “We now have 10 ongoing ADC collaborations, six collaborator ADCs using our technology are in clinical development, and several additional programs are advancing towards the clinic. We have generated more than $145 million from ADC licensing, and we have the potential to receive significant future milestones and royalties for ADCs developed by our collaborators.”

Pfizer is responsible for research, product development, manufacturing and commercialization of any ADC products. Seattle Genetics is eligible to receive more than $200 million in success-based milestones as well as royalties on worldwide sales. Seattle Genetics will also receive material supply and annual maintenance fees as well as research support payments.

Executive Moves: Biogen Idec

Posted on January 6, 2011 @ 09:02 am

Douglas E. Williams, Ph.D., has been named executive vice president of R&D at Biogen Idec and Steven H. Holtzman has been named executive vice president, corporate development. Dr. Williams will oversee the company’s global R&D operation, including discovery research, development, clinical operations and regulatory affairs. Mr. Holtzman will oversee corporate strategy, business development, portfolio management, program leadership and the New Ventures fund. Both will report to Biogen’s chief executive officer George A. Scangos, Ph.D.

Dr. Williams has more than 20 years of scientific and senior leadership experience, most recently as chief executive officer of ZymoGenetics Inc. He also served as head of research and a member of the executive team at Immunex, where he played a significant role in the discovery and development of rheumatoid arthritis drug Enbrel.

Mr. Holtzman has more than 20 years of industry experience, most recently as founder, chairman and chief executive officer of Infinity Pharmaceuticals. Mr. Holtzman also served as chief business officer of Millennium Pharmaceuticals.

“I am delighted to welcome Doug Williams and Steve Holtzman to Biogen Idec,” said Dr. Scangos. “I have known Doug and Steve for a long time and have great respect for their capabilities, accomplishments and character. Doug has repeatedly demonstrated the ability to build and lead high quality research groups and, importantly, to aggressively focus the science and transform promising research into products. Steve is one of the most thoughtful and creative business people I know and has demonstrated over the years the ability to build great organizations and create innovative collaborative structures that meet the needs of both partners. Steve and Doug represent the completion of what I believe is now an excellent management team. I look forward to working with both of them and the rest of the management team to take Biogen Idec to the next level.”

Executive Moves: DSM Pharmaceutical Products

Posted on January 5, 2011 @ 12:31 pm

Alexander Wessels has been named president and chief executive officer of DSM Pharmaceutical Products, the pharmaceutical ingredients and contract manufacturing organization of Royal DSM NV. He previously served as president and chief executive officer of DSM Food Specialties.

Mr. Wessels reports to Mr. Stephan Tanda, a member of the DSM Managing Board, and will oversee the implementation of DSM’s “driving focused growth” global strategy, as announced in September 2010, within the pharmaceutical products business group. The strategy includes sales from high growth economies, innovation and sustainability solutions, as well as from partnerships.

Mr. Wessels has worked in the life sciences, nutrition and pharmaceutical industries for 20 years, including four years at DSM, most recently as Business Group President of DSM Food Specialties, improving the performance of this global business and market leader. Prior to joining DSM, Mr. Wessels held various management and executive positions in the food, beverage and nutrition industries at Unilever, Quest International (Unilever), ICI, and Campina.

Headquartered in Parsippany, NJ, the DSM Pharmaceutical Products business group serves the global pharmaceutical and biopharmaceutical markets offering manufacturing services, R&D/formulation and technologies for biologics, APIs and intermediates, as well as finished dosage manufacturing. The business group works closely with all DSM pharma interests, including DSM Anti-Infectives.
Lonza Chooses IDBS EDM Solution

Posted on January 5, 2011 @ 08:19 am

Lonza has selected IDBS's Bioprocess Execution System as an electronic data management and execution solution for mammalian cell culture process development. The system is intended to optimize the management of process development data and drive operational excellence to Lonza customers.

"We believe that adopting IDBS's Bioprocess Execution System as our data management solution will help us improve our processes and enhance the quality of the services we provide to customers," said Dr. Steve Flatman, Lonza's head of Mammalian Development Services.

Data management systems like this one enable companies to integrate and optimize bioprocess workflows, capturing high-value data previously locked in paper records or isolated electronic files, across multiple locations and in different formats.

Generating complete laboratory-to-report lifecyles within one system, and making data retrievable by scientists to help in targeting process optimizations, will assist the drive for operational excellence, a core part of Lonza's strategy.

"IDBS continues to develop informatics solutions that address the critical business needs of high value R&D and manufacturing activities," said Neil Kipling, founder and chief executive officer of IDBS. "We believe that the bioprocess sector is an area of considerable growth and will benefit from our broad expertise and industry experience. We are delighted to be working with such an innovative company as Lonza, one of the first contract manufacturers to adopt our approach to process and knowledge management."
Executive Moves: PharmaNet Development Group

Posted on January 5, 2011 @ 08:09 am

Catherine Derasp, RN, has joined PharmaNet Development Group as vice president, Clinical Operations of Phase I clinics.

Ms. Derasp will oversee the management of the Company's 350 bed Phase I clinical operations that are located in Montreal and Quebec City, Canada. In addition to first-in-man and proof-of-concept phase I clinical services, Ms. Derasp will be responsible for a variety of studies in special populations, cardiac safety testing, and drug-drug interaction studies.

"We are thrilled to have Catherine join us," said Riaz Bandali, president, Early Stage Development. "Catherine's commitment to continual improvement and expertise in multi-site Phase I clinical operations, quality systems, and training brings the right combination of knowledge and experience to the PharmaNet Phase I clinical organization."

Ms. Derasp has more than 15 years of experience working for Phase I clinical research organizations. Her various leadership roles included managing global multi-site operations with specialization in operational quality and process improvement.
Executive Moves: MPI Research

Posted on January 5, 2011 @ 08:03 am

Dale M. Cooper, DVM, has been named director of Clinical Medicine at MPI Research. Dr. Cooper will oversee animal care for the company’s three core research divisions: Drug Safety Evaluation, Discovery Services, and Bioanalytical/Analytical Services.

Dr. Cooper, a Diplomate of the American College of Laboratory Animal Medicine, brings a broad scope of veterinary clinical medical experience to MPI Research. Most recently, he was the director of Laboratory Animal Medicine, Quality, and Technical Services for North America for Harlan Laboratories. Prior to that, he was a principal research scientist with Eli Lilly. Dr. Cooper also has experience in consulting and community veterinary medicine as well as academia. He received his DVM from the University of Wisconsin, Madison and is widely published in the animal husbandry literature.

Dr. Tina Rogers, PhD, MBA, DABT, director of Research and executive vice president at MPI Research, remarked, “Dr. Cooper has a proven track record of ensuring the highest possible standards of animal welfare. Our company is known for its commitment to conducting studies in an ethical and humane way, and with Dr. Cooper at the helm of our animal care program, this commitment is strengthened even further.”
Executive Moves: West Pharmaceutical Services

Posted on January 5, 2011 @ 08:00 am

Jeffrey C. Hunt President of the Pharmaceutical Packaging Systems business of West Pharmaceutical Services. The Pharmaceutical Packaging Systems business is West's largest unit, generating annual sales revenue of nearly $800 million.

Mr. Hunt joined West in July 2010 as vice president, Strategic Planning and Business Development. He has more than 23 years of experience in medical device and related businesses. Prior to joining West, he served as President of the $1.4 billion Patient Care and Safety Products Global Business Unit of Covidien. Prior to that, he was vice president and general manager of the SharpSafety Division of Tyco Healthcare/Kendall.

"Jeff joined West with a proven record of developing and implementing successful strategic initiatives in the med-device business units that he has managed," said Donald E. Morel, Jr., Ph.D., West's chairman and chief executive officer. "Since joining us, he has been working with the senior management team on our long-term business strategy and M&A efforts, and through those processes, developed key management relationships and acquired a deeper understanding of our operations. He is very well suited and prepared to lead Pharmaceutical Packaging Systems."

Mr. Hunt replaces Steven A. Ellers, 60, who resigned his position as president and chief operating officer in anticipation of his retirement during the first half 2011. He will provide transitional support to Mr. Hunt and senior management in the interim.

Commenting on Mr. Ellers' retirement, Dr. Morel said, "Throughout his career with West, Steve has held critical leadership positions and has played a significant role in the Company's growth. Steve served West around the world, including assignments in South America and Singapore and three years as Chief Financial Officer. We are grateful to Steve for his dedication and service to West, and for his recent efforts to insure an orderly succession. We wish him the very best."

In addition, Warwick Bedwell has been appointed president of the Asia-Pacific region of Pharmaceutical Packaging Systems, succeeding Ronald Van Dijk. Prior to joining West, Mr. Bedwell served as president and general manager of Roche (Philippines) Inc. and in managerial positions for Roche and Schering-Plough in Australia and, most recently, vice president and Commercial Director – Bone and Rheumatology for Roche Products (UK) limited.
Pfizer, Santaris Expand RNA Pact

Posted on January 4, 2011 @ 09:29 am

Santaris Pharma and Pfizer have expanded their collaboration for the development and commercialization of RNA-targeted medicines using Santaris Pharma’s Locked Nucleic Acid (LNA) drug platform. Santaris will receive a $14 million payment from Pfizer for access to its LNA technology and is eligible to receive milestone payments of as much as $600 million and royalties on sales of products for as many as 10 new RNA targets selected by Pfizer.

The original collaboration began in January 2009 between Santaris and Wyeth, which was acquired by Pfizer. Pfizer has advanced several programs under the original collaboration and has reached a number of early milestones.

"The expansion of our collaboration with Santaris Pharma demonstrates our strategic intention to partner with innovative biopharm/biotech companies to explore novel drug design technologies as a potential source for breakthrough therapeutics," said Mikael Dolsten, president of Worldwide R&D at Pfizer. He added, "We have been encouraged by the progress of our oligonucleotide collaboration with Santaris Pharma and are eager to explore this expanded partnership for potential additional LNA-based drug projects."

"The expanded alliance with Pfizer is a result of our successful collaboration over the last two years and provides further evidence that our LNA Drug Platform is rapidly becoming the technology-of-choice for partners interested in developing RNA-targeted medicines," said Soeren Tulstrup, president and chief executive officer of Santaris. "The LNA Drug Platform is well positioned to deliver viable drug candidates today, and we are excited to expand our relationship with Pfizer to pursue our goal of making RNA-targeted drugs for important diseases a reality."

AMRI, Genentech Enter Research Pact

Posted on January 4, 2011 @ 09:27 am

AMRI has entered a research and licensing agreement with Roche subsidiary Genentech to develop antibacterial compounds from AMRI’s natural products sample collection.

Genentech will have an exclusive license to develop and commercialize multiple potential products from AMRI’s antibacterial program. AMRI will receive an upfront license fee and research funding, and will be eligible to receive development regulatory milestones and royalties on sales of any commercialized compounds.

"We are very pleased to announce this collaboration with Genentech,” said AMRI’s vice president of R&D, Bruce J. Sargent, Ph.D. “As resistance to existing drugs continues to emerge, there is an urgent need for new antibiotic agents. This exciting collaboration brings together AMRI’s strengths and experience in small-molecule drug discovery, biology and chemistry with Genentech’s leading position in novel drug discovery and development.”

Servier To Co-Develop XOMA’s Anti-inflammatory

Posted on January 4, 2011 @ 09:25 am

XOMA Ltd. and Les Laboratoires Servier have signed an agreement to jointly develop and commercialize XOMA 052 in multiple indications. XOMA 052, an anti-inflammatory drug candidate, is designed to inhibit cytokine interleukin-1 beta, which is believed to be a primary trigger of pathologic inflammation in multiple diseases.

XOMA will receive approximately $35 million upfront and as much as $470 million in milestone payments and royalties. XOMA retains development and commercialization rights for Behcet's uveitis and other inflammatory and oncology indications in U.S. and Japan. Servier has similar rights in the rest of the world.

Servier will fund the first $50 million of development expenses and 50% of further expenses for the Behcet's uveitis indication, which is expected to enter Phase III development in 2011. Servier will fund development for diabetes and cardiovascular disease indications in exchange for worldwide rights, however XOMA retains an option to reacquire the rights to these indications in the U.S. and Japan.

"This is an important collaboration for XOMA as we gain a seasoned partner in Servier and it allows us to accelerate XOMA 052 into Phase III development this year in Behcet's uveitis. The agreement advances our strategy of focusing on opportunities in the U.S. where we can directly participate in the development and commercialization of our novel products," said Steven B. Engle, chairman and chief executive officer, XOMA.

Executive Moves: Bioniche

Posted on January 4, 2011 @ 09:22 am

Bioniche Life Sciences, Inc. will reorganize its corporate leadership team in an effort to increase efficiency and better position the company for strategic growth. In the Human Health business unit, Dr. François Charette, senior vice president of Medical Affairs and chief medical officer, has left the company. Monique Champagne, vice president, Clinical Research, will assume leadership and will be working with the Human Health team to identify and pursue new human health indications for the company's Mycobacterial Cell Wall-DNA Complex (MCC) technology. Ms. Champagne joined the company as director of Clinical Research in 2006.

In the Bioniche Animal Health business unit, Jim Phillips, president of Bioniche Animal Health, will now serve as senior vice president of industry relations. This is a strategic position to pursue potential product and technology acquisitions, as well as to be more engaged with the veterinarian community. Mr. Phillips has been with the company for 25 years and has provided strong leadership to the Animal Health division.

Andrew Grant, divisional president of Bioniche Animal Health Export Sales, Europe and Asia, has been promoted to president of Bioniche Animal Health. Mr. Grant has been with the company for 12 years and has a broad depth of knowledge of the industry and an excellent awareness of potential future growth opportunities for the business.

"Having successfully concluded an equity financing in December, the company is poised with the financial resources it requires to more efficiently advance a number of its key strategic projects," said Graeme McRae, chairman, president and chief executive officer of Bioniche Life Sciences. "At the same time, we must ensure that we have the appropriate people in key leadership positions to take advantage of the opportunities in front of us. I believe that the administrative reorganization achieves this objective."

Pfizer To Purchase Akorn-Strides Portfolio

Posted on January 3, 2011 @ 09:33 am

Akorn, Inc.’s joint venture, Akorn-Strides LLC, has entered into a purchase agreement with Pfizer to sell 16 ANDAs and six filed ANDAs. Akorn, Inc. will receive $35 million in cash and Akorn-Strides will continue to manufacture and distribute the approved products until April 30, 2011. In 3Q10, Akorn recognized $1.9 million in revenue as a result of the Akorn-Strides joint venture.

Raj Rai, Akorn’s chief executive officer, said, “This is a positive outcome for Akorn as the proceeds from the sale provide us with immediate access to capital to accelerate our infrastructure improvements, pursue acquisitions and in-licensing of niche pharmaceuticals, as well as strengthen our balance sheet. We would like to thank our joint venture partner, Strides, for helping build value in our joint venture which has resulted in a mutually beneficial strategic outcome.”

BASi, Pharmasset Enter Preclinical Services Pact

Posted on January 3, 2011 @ 09:32 am

BASi has entered into a Preferred Provider Agreement with NJ-based Pharmasset, Inc., a clinical-stage pharmaceutical company specializing in novel drugs to treat viral infections, to provide preclinical services for pre-IND and post-IND activities. The agreement includes exclusive toxicology services as well as pharmaceutical analysis and bioanalytical services as needed.

BASi president and chief executive officer Anthony S. Chilton, Ph.D., said, "The agreement between Pharmasset and BASi is an important strategy and commitment for both companies. It represents a significant step in BASi's strategy to work closely with our partners in the pharmaceutical industry. We look forward to developing our relationship and continuing to contribute to the successful development of Pharmasset's future medicines."

Executive Moves: Sartorius

Posted on January 3, 2011 @ 09:30 am

Dominique Baly has been appointed president of Sartorius’ group laboratory business, responsible for cross-divisional management of marketing, sales and service. Mr. Baly reports to the chief executive officer and is a member of the group executive committee that includes six executives of Sartorius AG and the subgroup Sartorius Stedim Biotech.

“With Dominique Baly, we are gaining an exceptionally experienced and successful manager for our team. He will give our laboratory business decisive momentum in this fast-evolving market environment to define the future positioning for significant growth,” said chief executive officer and executive board chairman, Dr. Joachim Kreuzburg.

Mr. Baly has more than 35 years of sales and managerial experience. He joins the company from Millipore Corp., which was acquired by Merck KGaA in 2010. From 2005 to 2008, he was president of the bioscience division. In 2009, he became chief executive officer of Accelerator Sciences LLC, a U.S. investment firm.

Executive Moves: Consumer Product Testing Co.

Posted on January 3, 2011 @ 09:29 am

Angie Inouye has been appointed director of business development for Consumer Product Testing Co. She will be based on the west coast and will support the western U.S., Canada, and South America, strengthening customer relations and driving sales efforts for the company’s worldwide markets.

Most recently, she served as director of business development for an OTC contract manufacturer in new product development of the manufacturing process. Ms. Inouye has nearly 20 years of experience working with a GMP testing lab, providing sales support and developing marketing strategies for the pharma/biotech, medical device and OTC/personal care industries.

"Bringing over 20 years of experience in our industry, she has the skills and talent to accelerate the growth of our business. We are very pleased to have her join our team," said Craig Weiss, president, CPTC.

"Her extensive sales and marketing experience will support CPTC’s commitment to meet our customer’s needs as we achieve our sales projections for 2011," said Leslie Eberspeacher, manger technical sales, Consumer Product Testing Co.

Ecron Acunova, Newcastle U Enter Clinical Research Pact

Posted on January 3, 2011 @ 09:27 am

Ecron Acunova and Newcastle University have partnered to explore ways of working together in the area of clinical trials. As part of the relationship, Ecron Acunova has contracted its first clinical research study at Newcastle University.

Newcastle University hosts one of the leading medical schools in the UK with a focus on translational research and has plans to expand its relationships with CROs overseas. Ecron Acunova CRO is based in India and continental Europe, with subsidiaries in Europe and the US. The partnership is part of the company’s plan to expand its operations in the UK.