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ePT--the Electronic Newsletter of Pharmaceutical Technology
Also, VaxGen and Raven terminate merger agreement, Darren Head appointed CEO of Cytovance, more...
Jerusalem, Israel (Mar. 31)-Teva Pharmaceutical Industries and Bentley Pharmaceuticals (Exeter, NH) entered into a definitive agreement under which Teva will acquire Bentley. The acquisition will take place following the spin-off of Bentley's drug delivery business to its shareholders, which Bentley announced on October 23, 2007. At closing, Bentley will consist solely of the generic pharmaceutical operations and will be bought by Teva for an aggregate cash purchase price of approximately $360 million. Bentley markets its products primarily in Spain but also sells generic pharmaceuticals in other parts of the European Union. These efforts are supported by finished dosage and active pharmaceutical ingredient manufacturing facilities. Bentley's generic pharmaceutical operations generated revenues of approximately $114 million for the year ended December 31, 2007.
Buffalo Grove, IL (Mar. 24)-Akorn, a manufacturer of sterile specialty pharmaceuticals, signed a five-year commercial manufacturing and supply agreement with a US ophthalmic company. Under the terms of the agreement, Akorn will be responsible for the exclusive manufacturing and supply of three OTC eye-care products. The line of products will be manufactured at Akorn’s Decatur, Illinois, facility and are targeted for distribution in the US and worldwide markets.
Bloomington, IN (Mar. 25)-BioConvergence, a contract solutions provider for the biotech and pharmaceutical industries, hosted a ribbon-cutting ceremony at its Bloomington, Indiana, headquarters to announce a 10-year, multi-million dollar partnership with Eli Lilly to provide global materials management services for Lilly’s large and growing pipeline of products. BioConvergence is planning an investment in new equipment and a 21,000-ft2 expansion and predicts the need for an additional 170 jobs to meet the demands of the deal with Lilly.
East Rutherford, NJ (Mar. 21)-Cambrex announced that one of its customers is recalling one of their products for which Cambrex currently supplies the active pharmaceutical ingredient (API). Based on information provided to date, the recall decision is not linked in any way to Cambrex’s performance as the manufacturer of the API.
Framingham, MA (Mar. 27)-GTC Biotherapeutics entered into an extended agreement with PharmAthene (Annapolis, MD), a biodefense company, under which GTC will provide continuing process development and clinical supply manufacturing services for PharmAthene’s “Protexia” program. The manufacturing work is planned to conclude in the third quarter of 2008. Protexia is a recombinant form of human butyrylcholinesterase (rBChE) produced in the milk of transgenic goats, which is being developed by PharmAthene as a pre- and post-exposure therapy for victims of a chemical nerve agent attack.
Also, on March 20, PharmAthene and Avecia Biologics (Tees Valley, UK), a contract manufacturer of biopharmaceuticals, entered into a definitive sale and purchase agreement under which PharmAthene will acquire all of the assets and intellectual property related to Avecia’s biodefense vaccines business. As part of this agreement, the companies have entered into a long-term manufacturing contract for the supply of these vaccine drug substances to PharmAthene.
Princeton, NJ (Mar. 27)-Laureate Pharma, a biopharmaceutical company, entered into a CGMP contract manufacturing agreement with Cytheris (Paris, France), a clinical-stage biopharmaceutical company focused on research and development of new therapies for immune modulation. According to the agreement, Laureate will manufacture Cytheris’ lead product candidate, Interleukin-7 (IL-7), a fully glycosylated recombinant human protein and critical growth factor for immune T-cell recovery, for use in ongoing international clinical trials for treatment of HIV, HCV and cancer. Terms and conditions of the agreement were not disclosed.
New York (Mar. 31)-Pfizer received a positive ruling on enantiomer patent covering the calcium salt of atorvastatin, the active ingredient in Lipitor, from the Court of Appeal of Barcelona. This reversed the lower court decision. The enantiomer patent expires in July 2010. On March 20, the Federal Court of Appeal of Canada reversed a lower court ruling that held that Pfizer’s enantiomer patent could not block generic manufacturer Ranbaxy Laboratories (Gurgaon, India) from obtaining approval for a competitor product to Lipitor. The appellate court issued an order prohibiting regulatory approval of Ranbaxy’s product in Canada until Pfizer’s patent-Canadian Patent No. 2,021,546-expires in July 2010.
Research Triangle Park, NC (Mar. 26)-Quintiles Transnational, a contract research organization, announced an agreement with Medca Japan to provide central laboratory services. This will extend the Quintiles global network of laboratories certified by the College of American Pathologists (CAP). Quintiles will have its own staff at the Medca Japan laboratory in Saitama, a city in the greater Tokyo area. The lab will support clinical trials in Japan.
Midland, MI (Apr. 1)-The Dow Chemical Company announced plans to divest the portion of its Dowpharma Small Molecules business associated with its United Kingdom sites in Mirfield and Cambridge to Dr. Reddy’s Laboratories (EU) Limited, a subsidiary of Dr. Reddy’s Laboratories Limited of Hyderabad, India. The transaction is scheduled to close on April 30, 2008 pending regulatory approval. The planned divestment will include associated product and process technology, intellectual property, and trademarks as well as the transfer of the Mirfield and Cambridge facilities. Employees at the Cambridge and Mirfield sites will become part of Dr. Reddy’s on closing.
Shenzhen, China (Mar. 20)-Tongjitang Chinese Medicines Company, a specialty pharmaceutical company focusing on modernized traditional Chinese medicine in China, signed a definitive purchase agreement to acquire Qinghai Pulante Pharmaceutical, a privately owned plant-based pharmaceutical company. Qinghai develops, manufactures, markets, and distributes Tibetan recipe-originated medicines in China. Tongjitang anticipates that consideration for the acquisition will be in cash, with an initial payment of approximately RMB 25.5 million ($3.6 million), and the company will make additional payments over the next three years based on Pulante’s financial and operational performance. The transaction is subject to customary regulatory approvals.
South San Francisco, CA (Mar. 28)-VaxGen, a biopharmaceutical company, and Raven biotechnologies (South San Francisco, CA) have mutually agreed to terminate their merger agreement. This decision comes because of stronger-than-anticipated opposition to the proposed merger by VaxGen stockholders and both companies believe the proposed merger and related equity plan proposals would be rejected by VaxGen stockholders.
Hopkinton, MA (Mar. 25)-VelQuest, the developer of a paperless compliance management system for pharmaceutical quality laboratory operations, was selected by AstraZeneca (London) for VelQuest’s global quality eLab informatics IT architecture. The “SmartLab” GMP Electronic Notebook System will automate AstraZeneca’s quality control and quality assurance lab operations with integration to its commercial laboratory information management system and enterprise resource planning system.
Montvale, NJ (Mar. 28)-The Chairman and Chief Executive Officer of Barr Pharmaceuticals, Bruce L. Downey, announced the following changes to its senior management team: Christine Mundkur is now CEO of Barr Laboratories, the company’s generic pharmaceutical business; and Fred Wilkinson is now CEO of Duramed Pharmaceuticals, the company’s proprietary products business. Mundkur and Wilkinson will report directly to Downey, who will retain the position of chairman and CEO of Barr Pharmaceuticals but will no longer have the day-to-day management responsibilities that he assumed in August 2007. In addition, Mike Bogda was named president and chief operating officer at Barr Laboratories, and will report to Mundkur, and Bill McKee, executive vice-president and chief financial officer at Barr Pharmaceuticals, will assume expanded responsibilities.
Somerset, NJ (Mar. 28)-Catalent Pharma Solutions appointed Matthew M. Walsh senior vice-president of finance and chief financial officer, effective April 7, 2008. David A. Eatwell will be leaving this position at Catalent effective April 4, 2008 to pursue other opportunities. Walsh was most recently president and chief financial officer of Escala Group, a collectibles network and precious metals trader.
Concord, CA (Mar. 31)-Cerus named Carol M. Moore vice-president of regulatory affairs and quality. Prior to joining Cerus, Moore was vice-president of worldwide regulatory affairs for Bayer.
Oklahoma City, OK (Mar. 28)-Cytovance, a biopharmaceutical contract manufacturing organization, named Atlanta biotechnology executive Darren Head chief executive officer. Head comes to Cytovance from Immucor, where he served as vice-president of worldwide operations.
New York (Mar. 31)-ImClone Systems appointed Kenneth J. Zuerblis senior vice-president and chief financial officer, effective March 31, 2008. Zuerblis has 25 years of experience in the industry and is the former CFO of Enzon Pharmaceuticals.