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ePT--the Electronic Newsletter of Pharmaceutical Technology
Also, Quintiles to expand Singapore operations; Christine A. Poon, chairman of Johnson & Johnson's pharmaceuticals group, to retire; more...
Dayton, OH (Sept. 16)-AcuTemp Thermal Systems, a manufacturer of high-performance insulation and temperature-sensitive packaging technology for the cold chain, formed a joint venture with AmSafe (Phoenix, AZ), a provider of safety and securement equipment to the transportation market. The joint venture, CSafe, has locations in Washington and Ohio, and will focus on developing cold-chain technologies for shipping pharmaceuticals and other perishable products.
Cranbury, NJ (Sept. 15)-Amicus Therapeutics, a biopharmaceutical company focused on pharmacological chaperone technology to develop a new class of drugs to treat human genetic diseases, has leased laboratory space for a focused, small-scale research facility in San Diego. The facility will be used to support ongoing research, and Amicus expects to begin occupying the space immediately.
Leverkusen, Germany (Sept. 16)-Bayer HealthCare acquired DIREVO Biotech AG (Cologne, Germany) in a cash deal at a transaction value of €210 million ($354 million). DIREVO Industrial Biotechnology GmbH, a wholly owned subsidiary of DIREVO Biotech AG, is not subject to this transaction and has been sold in a separate deal to a group of financial investors. Bayer Healthcare plans to integrate DIREVO Biotech's research and development personnel and the Cologne site into Bayer Schering Pharma's global drug discovery organization.
Stockholm, Sweden (Sept. 15)-Biovitrum and Amgen (Thousand Oaks, CA) entered into an agreement under which Biovitrum will acquire the marketed biologic therapeutic products “Kepivance” (palifermin) and “Stemgen” (ancestim) from Amgen, and will also obtain a worldwide exclusive license to “Kineret” (anakinra) for its current approved indication. The agreement includes an inventory of the three products at an undisclosed value. The financial terms of the transaction include an upfront payment of approximately $130 million, consisting of $110 million in cash and ordinary shares of Biovitrum, representing a value of $20 million at the time of closing, subject to certain adjustments provided in the acquisition agreement. In addition, the agreement provides for the payment of sales milestones. The transaction is expected to close by the end of 2008.
Parsippany, NJ and Toulouse, France (Sept. 16)-DSM and LibraGen, a biotechnology company, signed an agreement to codevelop new omega-transaminases for production of chiral amines. Under the terms of the partnership, LibraGen will use its proprietary enzyme discovery and development to identify new enzymes for efficient conversion of a large spectrum of ketons into optically pure R- and S-amines, a compound class used in the fine chemicals and pharmaceuticals industries. DSM will produce the enzymes at industrial scale. LibraGen will sell the enzymes in kit form, and both parties will use them for screening activities and the development of biocatalytic processes for third parties. Financial details were not disclosed.
Bristol, TN (Sept. 12)-The specialty drug company King Pharmaceuticals raised its bid for Alpharma (Bridgewater, NJ), a specialty pharmaceutical company, by 12%. King commenced a tender offer to acquire all of the outstanding shares of Class A common stock of Alpharma for $37 per share in cash. This price represents a total equity value of approximately $1.6 billion and an enterprise value of approximately $1.4 billion. The tender offer is scheduled to expire at 5:00 pm EST on Oct. 10, 2008. Alpharma’s board of directors urged shareholders to take no action with respect to King’s tender offer, and plans to make a recommendation to shareholders within 10 business days following the commencement of the tender offer. Alpharma announced that the board is exploring all strategic alternatives to maximize shareholder value, including a possible sale of the company to King or to another party.
Research Triangle Park, NC (Sept. 10)-Quintiles Transnational will expand its Singapore operations. The new regional headquarters will be double the size of its existing presence in Singapore. Quintiles' Asia-Pacific growth also has led to expansion of seven local offices in the region and the addition of a new location in Indonesia. Quintiles' Central Laboratory and its Clinical Development Services offices will move into approximately 80,000 ft2 of space in the Cintech IV building, now under construction in Singapore's Science Park One. The move is planned in the third quarter of 2009.
Rockville, MD (Sept. 15)-The US Food and Drug Administration'sfinal rule on exemption of early Phase I investigational drugs from certain current good manufacturing practice (CGMP) regulations took effect this Monday, Sept. 15, 2008. The final rule was published in the Federal Register in July 2008. The agency’s companion guidance, CGMP for Phase I Investigational Drugs, recommends approaches for complying with CGMP requirements for the exempted Phase I investigational drugs.
Lionville, PA (Sept. 8)-West, a manufacturer of components and systems for injectable drug delivery, completed its expansion work at its Kinston, North Carolina, manufacturing facility. The expanded plant provides additional compounding and custom manufacturing capabilities and will bring more than 150 new jobs to Kinston and surrounding communities.
Markham, Ontario, Canada (Sept. 16)-Cytochroma appointed Steven I. Engel vice-president of regulatory affairs and quality assurance. Engel will be responsible for directing all of Cytochroma's regulatory activities, as well as ensuring that the company has appropriate quality systems in place. He will be based in Cytochroma's Illinois office.
Wayne, PA (Sept. 10)-Encorium Group, a clinical research organization appointed David Ginsberg chief executive officer of Encorium Group. Ginsberg assumes the position from Kai Lindevall, who was named to the newly created role of executive chairman.
South San Francisco, CA (Sept. 10)-Genentech appointed Morgan Sheng vice-president of neuroscience, effective September 15, 2008. In this newly created position, Sheng will be responsible for directing neurobiology drug discovery efforts at Genentech.
New Brunswick, NJ (Sept. 12)-Johnson & Johnson announced that Christine A. Poon, vice-chairman of the board of directors and worldwide chairman of the pharmaceuticals group, plans to retire on March 1, 2009, from the company and the board.
Bothell, WA (Sept. 15)-MDRNA appointed Chief Executive Officer J. Michael French to the company’s board of directors. French will also assume the additional role of president effective October 1, 2008.
Waltham, MA (Sept. 16)-NeurAxon, a developer of next-generation pain therapeutics, appointed Thomas Lategan vice-president of regulatory affairs. Lategan has more than 20 years of experience in pharmaceutical regulatory affairs and project management.