|Email Newsletters from Pharmaceutical Technology and Pharmaceutical Technology Europe|
Providing the latest business, scientific, and regulatory news for the pharmaceutical and biotech industries.
News from Europe's pharmaceutical manufacturing industry coupled with upcoming events, and exclusive articles and interviews from industry experts.
Week of Jan. 31, 2011: Company and People Notes: Pfizer Completes King Tender Offer; Cook Pharmica Names VP of R&D and CSO; and More.
Arena Pharmaceuticals will reduce its US workforce by approximately 25%, or 66 employees, by March 28, 2011. The company said in a statement that it will focus its resources on working to obtain regulatory approval of its obesity drug lorcaserin, seeking collaborators for the commercialization of lorcaserin outside of the US, and advancing select earlier-stage research and development programs independently or in partnership.
Bristol-Myers Squibb and sanofi aventis received from FDA an additional six-month period of exclusivity to market Plavix (clopidogrel bisulfate) based on receving pediatric exclusivity. Exclusivity for the drug in the US is now scheduled to expire on May 17, 2012.
Catalent Pharma Solutions, a provider of development, technology, and manufacturing services, entered into an agreement with Nuron Biotech for the formulation and supply of NU100 (interferon beta-1b), a recombinant human interferon beta compound being developed for the treatment of multiple sclerosis. Catalent will produce NU100 at its facility in Brussels, Belgium, where the product will be formulated, filled, and packaged in a prefilled syringe. Nuron Biotech plans to begin Phase III clinical trials of NU100 in 2011.
EMD Millipore, the life science division of Merck KGaA of Germany, formed an agreement with Novo Nordisk to transfer the distribution of recombinant human insulin for cell-culture media to Novo Nordisk. Starting on May 1, 2011, recombinant human insulin products for cell-culture media applications, branded by EMD Millipore as Incelligent SG and Incelligent AF, will be supplied directly from the manufacturer, Novo Nordisk.
Endo Pharmaceuticals formed an oncology drug-development pact with Orion, a pharmaceutical and diagnostic company. The collaboration enables the companies to develop eight "discovery phase" candidates by combining an equal number of programs. In addition, under the agreement both companies can exclusively license the others' development-ready programs at predetermined stages and share all development costs.
Genzyme will allow sanofi aventis to conduct due diligence in consideration of sanofi aventis' bid to acquire Genzyme. A company statement said that discussions between the companies are ongoing, but that Genzyme can provide “no assurance” that the discussions will result in any particular transaction.
GlaxoSmithKline and Actelion discontinued the clinical development of the Phase III investigational dual orexin receptor antagonist, almorexant. The decision follows a review of data from additional clinical studies, which were conducted to further establish the clinical profile of almorexant, including the tolerability profile, according to a company press release.
H3 Biomedicine, a new biopharmaceutical company focused on personalized medicine, launched research and development operations. Pharmaceutical company Eisai has pledged up to $200 million in research funding to H3 Biomedicine, as well as additional clinical-development support. See a related blog post on PharmTech Talk.
Johnson & Johnson and the biopharmaceutical company Crucell received approval of J&J’s proposed acquisition of Crucell from the European Commission. A company statement detailed the remaining timetable of the offer process, which includes a Feb. 8, 2011, offer extraordinary general meeting, and a Feb. 16 acceptance closing time.
Pfizer completed its tender offer for all outstanding shares of common stock of King Pharmaceuticals at a purchase price of $14.25 per share. The shares validly tendered and not validly withdrawn represent approximately 92.5% of the outstanding shares of King common stock. Pfizer intends to complete the acquisition of King through a short-form merger on or about February 28, 2011, and King will become a wholly owned subsidiary of Pfizer.
Pfizer will close its research and development (R&D) facility in Sandwich, UK, the company said in its fourth-quarter report. The Sandwich facility conducts research in the therapeutic areas of allergy and respiratory disease. Additional changes to Pfizer’s R&D operations include shifting selected resources from its Groton, Connecticut, plant to Cambridge, Massachusetts, and outsourcing certain functions. Pfizer plans to enhance its presence in Cambridge, UK, and in the US in Cambridge, New York, San Francisco and La Jolla, California.
Seven major research-based medical centers in New York City, including Rockefeller University, NYU Langone Medical Center, Memorial Sloan-Kettering Cancer Center, The Mount Sinai Medical Center, Columbia University Medical Center, Albert Einstein College of Medicine of Yeshiva University, and Weill Cornell Medical College, have joined Pfizer’s Centers for Therapeutic Innovation, a network of partnerships that aims to speed the translation of biomedical research into medicines. The first Center was established in November of last year at the University of California, San Francisco.
sanofi aventis and its US consumer healthcare division, Chattem, received FDA approval for the over-the-counter use in adults and children two years of age and older of the Allegra (fexofenadine HCl) family of allergy medication products. The drug will be available without a prescription in March 2011.
Tibotec Pharmaceuticals, part of Johnson & Johson, granted licenses to generic-drug manufacturers, including Hetero Drugs, Matrix Laboratories (a Mylan company), and Aspen Pharmacare, to manufacture, market, and distribute the investigational non-nucleoside reverse transcriptase inhibitor rilpivirine hydrochloride (TMC278), pending its approval for use with other antiretroviral agents in the treatment of treatment-naïve HIV-1-infected adults. Under the agreement, the generic-drug manufacturers will be entitled to manufacture once-daily 25 mg TMC278 as a single agent medicine and a fixed-dose combination (FDC) product.
The recall of Triad brand alcohol prep pads due to possible contamination prompted pharmaceutical manufacturers to issue statements about their products packaged with the affected pads. Pfizer and Progenics Pharmaceuticals advised customers not to use the Triad pads packaged for use with the kit presentation of Relistor (methylnaltrexone bromide) subcutaneous injection in the US. Merck issued a similar warning about the recalled pads to customers who use Pegintron (peginterferon alfa-2b) single dose RediPen and Pegintron vials for markets in Europe, Asia Pacific (excluding Japan), Latin America and Canada, and Intron A (interferon alfa-2b) Multidose RediPen and Intron A solution vials for markets in Europe, Asia Pacific (excluding Japan) and Latin America. Merck medicines distributed in the United States are not impacted by the Triad Group recall.
Contract manufacturing organization AMRI appointed Takeshi Yura assistant director of medicinal chemistry. Yura will report to Managing Director Raymond Yeung at the company's drug-discovery services operations in Singapore.
E. Morrey Atkinson joined Cook Pharmica as vice-president of research and development and chief scientific officer. He was previously head of biotechnology manufacturing sciences and technology at Eli Lilly.
Delenex Therapeutics, a biotechnology company, appointed Eric de La Fortelle as its CEO and Jakob Schlapbach as its CFO.
Susan Schniepp, vice-president of quality at OSO BioPharmaceuticals Manufacturing has been elected to the board of directors at the Parenteral Drug Association. Schniepp also is a member of Pharmaceutical Technology’s editorial advisory board.
Pfizer appointed Yvonne Greenstreet senior vice-president and head of medicines development for its specialty-care business unit. Greenstreet succeeds Michael Berelowitz, who is retiring. Greenstreet will report directly to Geno Germano, president and general manager of Pfizer’s specialty-care business unit.
Global specialty biopharmaceutical company Shire appointed Emmanuel Chantelot, former executive director of European Biopharmaceutical Enterprises, as director of European government relations and public policy.