Company news: GlaxoSmithKline, Merck KgaA, Pfizer and Protalix
GlaxoSmithKline will lend its labs and equipment to test athletes for performance-enhancing drugs at the 2012 Olympic Games in London. GSK, based in the London suburb of Brentford, is partnering with King's College London on the lab, which will be accredited by the World Anti-Doping Agency. The company told The Financial Times that in accordance with the terms of the deal, it would associate only its corporate brand, not those of any products, with the games.
Merck KgaA received a "refuse to file" letter from the FDA for cladribine, the first oral drug for the treatment of relapsed remitting multiple sclerosis (MS). Such letters are issued when the FDA finds an NDA is incomplete. Merck KGaA's Merck Serono unit, which made the filing in September, plans to resubmit the application after talking with the agency to determine what would be required for the NDA to be accepted for review. The setback derails Merck's plan to launch the drug in the US by second-quarter 2010 and eliminates a time advantage Merck had held over Novartis, which is also developing an oral MS compound (FTY720/fingolimod) and plans to file it with US and EU regulators by year's end. Biogen Idec, which markets injectable MS drugs Avonex and Tysabri, is also developing an oral MS drug (BG-12), but the agent is not as far along as those of Merck or Novartis.
Pfizer acquired rights to a drug being developed to treat Gaucher's disease from Protalix, an Israeli biotech company. Terms call for Pfizer to make a $60-million up-front payment to Protalix, plus as much as $55 million in milestone payments, and for the companies to split marketing expenses and revenue on a 60-40 basis, the larger share to be paid by Pfizer. Protalix is close to filing with the FDA, and the product, taliglucerase alfa, could reach market next year. The move is a shot across the bow for Genzyme, whose Gaucher's drug Cerezyme has become that firm's best-selling product. Genzyme has also experienced manufacturing issues, which have led to delays in meeting patient demand for Cerezyme, although the company said it expects to be able to meet full patient demand by first-quarter 2010. Particle contamination was recently found in five of its products, and a plant which makes Cerezyme and other drugs is just coming back on line after having been shut down due to viral contamination. Protalix and Shire, which has filed for FDA approval of its drug Vela for Gaucher's disease, will present competition for Genzyme. Cerezyme is expected to see market share erosion of about 30% to Vela and Pfizer/Protalix by 2013, Jefferies & Co. analyst Eun Yang said in a recent note.