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Also, Alpharma advises shareholders to reject King's offer; ImClone rejects raised BMS offer; Immunogen appoints Daniel M. Junius, more...
Bridgewater, NJ (Sept. 26)-The board of directors of Alpharma, a specialty pharmaceutical company, informed shareholders of its decision to reject the unsolicited tender offer by King Pharmaceuticals, calling the $37-per-share offer “financially inadequate.” Alpharma’s board advised shareholders not to tender shares, and that it was exploring alternatives such as sale to another company.
New York (Sept. 23)-Bristol-Myers Squibb (BMS) raised its bid for ImClone to $62 per share, the value increasing from about $4.5 billion to $4.7 billion, and said it intends to commence a tender offer. BMS currently owns approximately 17% of ImClone. Carl C. Icahn, ImClone's chairman, called the increased offer "absurd" in a Sept. 23 letter to James M. Cornelius, chairman and CEO of Bristol-Myers Squibb. ImClone previously rejected BMS’s offer for $60 per share.
Princeton, NJ (Sept. 29)-Covance, a provider of drug development services, and WuXi Pharmatech (Shanghai) will no longer pursue a 50-50 joint venture to provide preclinical contract research services in China. Covance says it plans to build its own facility, as it had originally planned, according to a company press release.
London (Sept. 30)-GlaxoSmithKline said it was planning to cut up to 850 research and development jobs in Britain and the United States, according to a Bloomburg report. These cuts are in addition to the 350 eliminated R&D positions announced in June (as reported in ePT’s Company and People notes), and the staff reductions are part of the company’s restructuring plans that began in October 2007 to increase productivity.
Basel, Switzerland (Sept. 25)-Lonza and Crucell (Leiden, The Netherlands) entered into a manufacturing, sales, and distribution agreement related to the “PERMEXCIS” cell culture medium developed by Crucell for “PER.C6” cells. Under the agreement, Lonza will manufacture, market, and sell the medium on a global basis. Financial details of the agreement were not disclosed.
Rockville, MD (Sept. 29)-FDA recently posted on its website an Aug. 12 warning letter to Mallinckrodt addressing the company’s responses to a Form 483 issued in March 2008 at its Maryland Heights, Missouri facility. FDA’s March inspection of the facility cited “serious deviations” from current good manufacturing practice regulations including failure to establish and follow proper test procedures. The Aug. 12 letter acknowledges corrective steps taken thus far and identifies steps the company must take to be in compliance.
Washington, DC (Sept. 22)-The US President's Emergency Plan for AIDS Relief (PEPFAR) program will no longer purchase three AIDS drugs made by Ranbaxy Laboratories. The three drugs, “zidovudine,” “lamivudine,” and “nevirapine,” are manufactured at the company’s Dewas and Paonta Sahib facilities in India. FDA issued warning letters and an import alert citing violations of good manufacturing practices for the two facilities on Sept. 16. Read the related blog post on PharmTech Talk.
Annapolis, MD (Sept. 26)-PharmAthene, a company developing medical countermeasures against biological and chemical threats, was awarded a multiyear contract for up to $83.9 million by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. The contract is for the development of a third-generation recombinant protective antigen (rPA) anthrax vaccine that can be stored, transported, and used without the need for a conventional cold chain. The goal is to develop a vaccine that will be stable for three years at 35 ºC and provide protective immunity in one or two doses.
Rockville, MD (Sept. 24)-The US Pharmacopeial (USP) Convention released its first certified reference material (CRM), dextromethorphan hydrobromide. USP recently became the first global pharmacopeia to receive International Organization for Standardization accreditation as producer of chemical CRMs. Each CRM comes with a certificate of analysis containing data on certified property value, uncertainty value, and an expiration date (period of validity), all of which are designed to produce a higher level of trueness and traceability in the measurement of product and ingredient specifications. See USP’s website for more information on USP’s reference standards and certified reference materials.
Watertown, MA (Sept. 25)-Acusphere, a specialty pharmaceutical company, announced Michael R. Slater will assume the position of senior vice-president of regulatory affairs and operations, effective Sept. 29, 2008, following the decision of Dennis Bucceri to leave the company for another opportunity. Slater is currently senior vice-president of operations.
Needham, MA (Sept. 29)-AVANT Immunotherapeutics will change its name to Celldex Therapeutics, effective Oct. 1, 2008. Shares of the company’s common stock will be listed on NASDAQ under the ticker symbol “CLDX” effective at market opening on the same day. The board of directors appointed Anthony S. Marucci, who has been serving as interim president and chief executive officer (CEO) since May 2008, to the position of president and CEO of the company.
Waltham, MA (Sept. 30)-ImmunoGen appointed Daniel M. Junius, currently president and chief operating officer (COO) of the company, to the position of president and CEO effective Jan. 1, 2009. Junius also has been nominated to join the board. Mitchel Sayare, currently chairman and CEO, will continue as the chairman of the board and as a director of the company.
Bethesda, MD (Sept. 24)-Elias A. Zerhouni, MD, the director of the National Institutes of Health (NIH), plans to step down at the end of October 2008 to pursue writing projects and explore other professional opportunities. Zerhouni served as NIH director since May 2002.
Miami (Sept. 29)-Noven Pharmaceuticals, a specialty pharmaceutical company, appointed Peter G. Amanatides vice-president of quality assurance and quality control, effective immediately. Amanatides will lead all aspects of Noven’s quality functions.
Redwood City, CA (Sept. 25)-The biotechnology company PDL BioPharma named Faheem Hasnain president and CEO as well as a director of the company, effective Oct. 1, 2008. The company plans to separate its biotechnology and royalty operations, and Hasnain will become the president and CEO of the spinoff company, which will be known as Facet Biotech Corporation. PDL is still searching for a CEO to lead the royalty-focused spinoff entity, which will retain the PDL BioPharma name.
Vancouver, British Columbia, Canada (Sept. 29)-Tekmira Pharmaceuticals, a biopharmaceutical company, appointed Tammy Mullarky vice-president of strategic planning and business development, and Peter Lutwyche vice-president of pharmaceutical development.