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Company and People Notes: Evotec and Renovis enter agreement, Amgen to lay off 675 workers, more.
Hamburg, Germany and South San Francisco, CA (Sept. 19)-Evotec and Renovis entered into a definitive agreement under which Evotec will acquire Renovis, a biopharmaceutical company, in a stock-for-stock transaction valued at approximately $151.8 million. The merger is expected to create a global pharmaceutical company with three clinical candidates, a late-stage preclinical pipeline focused on neurological and inflammatory diseases, and pro-forma cash of approximately $175 million. The merged company will be called Evotec.
South San Francisco, CA (Sept. 21)-Exelixis signed an extension of the company’s research collaboration agreement with Bristol-Myers Squibb Company to develop and commercialize novel therapies targeted against the liver X receptor, a nuclear hormone receptor implicated in a variety of cardiovascular and metabolic disorders. The collaboration has been extended through January 12, 2009. Bristol-Myers Squibb also has retained the option to further extend the research collaboration by an additional year. Terms of the extension include additional research funding paid to Exelixis in the amount of $7.5 million. Under the terms of the collaboration, the two companies jointly identify drug candidates that are ready for investigational new drug application-enabling studies. Bristol-Myers Squibb then undertakes further preclinical development and has responsibility for clinical development, regulatory, manufacturing and sales/marketing activities for such compounds.
Pompey, France (Sept. 18)-Groupe Novasep is finalizing discussions to acquire Bahamas-based PharmaChem Technologies (Grand Bahama) for an undisclosed amount. The companies hope to combine Novasep’s R&D capabilities and technologies with PharmaChem’s manufacturing capacity to produce APIs and intermediates. PharmaChem's facility, based in Freeport, Bahamas, is a CGMP-compliant and FDA-inspected plant.
Gaithersburg, MD (Sept. 24)-MedImmune licensed its proprietary reverse genetics intellectual property to GlaxoSmithKline (London) to support the development and construction of new vaccine strains to produce nonlive human influenza vaccines. Reverse genetics is a method by which viruses such as influenza can be generated from segments of DNA, which can be useful because the process does not require manufacturers to work directly with potentially highly infectious pandemic strains, rather only with segments of the virus’s genome.
Raleigh, NC (Sept. 19)-North Carolina State University opened an 86,000-ft2 biotechnology training and education center to teach manufacturing sciences in a real-time environment. Commercial-grade equipment is being used for the first time in a pilot-scale training facility to train students in microbial fermentation and cell structure biotechnologies for the development of protein-based therapeutic drugs and commercial products. The facility, called the Biomanufacturing Training and Education Center, or BTEC, employs ABB’s “Industrial IT System 800xA Extended Automation” technology, instrumentation, analyzers and variable speed drives to achieve continuous validation and control of the bioreactors for real-time release under strictly maintained and regulated conditions.
Rockville, MD (Sept. 20)-The US Food and Drug Administration proposed a change to its regulation on the use of chlorofluorocarbons (CFCs) in metered dose inhalers (MDIs) for epinephrine. The rule would remove the “essential-use” designation that allows the use of CFCs in these medical devices. The use of CFCs is generally banned in consumer aerosols, but the Clean Air Act allows CFCs to be used in medical products if FDA determines the use is essential. FDA has tentatively concluded that there are no substantial technical barriers to formulating epinephrine as a product that does not release CFCs. Under the proposed rule, epinephrine MDIs containing CFCs would be removed from the market by the end of 2010.
Thousand Oaks, CA (Sept. 25)-Amgen plans to lay off about 8% of the company’s 8,300 Thousand Oaks workers this fall. The 675 layoffs at the company’s headquarters make up nearly half of the 1,500 Amgen jobs that will be trimmed nationwide and in Puerto Rico.
South San Francisco, CA (Sept. 20)-The biopharmaceutical company Novacea announced that John P. Walker was elected as chief executive officer, effective immediately. Walker has been chairman of Novacea since July 2006, and was named interim CEO in December 2006. He will maintain his role as chairman.
Montreal (Sept. 26)-Osprey Pharmaceuticals, a privately held biotechnology company, appointed Jack M. Anthony as chief executive officer. Dr. Philip Coggins, who previously held the position of CEO, will continue as president and assume the new role of chief scientific officer.
Cranbury, NJ (Sept. 26)-The biopharmaceutical company Palatin Technologies is taking steps to reduce its workforce by 30%, resulting in annual savings of $4 million. The downsizing will leave the company with 64 employees. Palatin will take an estimated $500,000 charge for severance payments in the quarter ending September 30, 2007.
South San Francisco, CA (Sept. 26)-Titan Pharmaceuticals, biopharmaceutical company, appointed Dr. Marc Rubin as president and chief executive officer starting October 1, 2007. Rubin will also be a member of the board of directors.
Rockville, MD (Sept. 21)-The US Food and Drug Administration named Janet Woodcock as acting director for the Center for Drug Evaluation and Research (CDER). Woodcock replaces Steven Galson, who is leaving to become acting surgeon general, effective Oct. 1, 2007. Woodcock will retain her position as FDA deputy commissioner and permanent chief medical officer. In addition to assuming the day-to day operational responsibilities of center director, she will work directly with FDA Commissioner Andrew C. von Eschenbach in launching a national search for a permanent center director.
In another announcement, FDA named Timothy Coté as the new director of FDA’s Office of Orphan Products Development. Coté, whose experience ranges from medical epidemiology to clinical research, will be responsible for promoting the development of products that demonstrate promise for the diagnosis or treatment of rare diseases or conditions.