Roche delays CERA US FDA filing, Amgen gains

13 February 2006

Shares in US biotechnology major Amgen rose as the market reacted to news that Swiss drug major Roche would delay filing for its anemia drug CERA, a continuous erythropoietin receptor activator, which might allow Amgen's Aranesp (darbepoetin alfa) to dominate the market.

Roche says it plans to file worldwide marketing applications for its first-in-class drug, which delivers sustained stimulation of red blood cell formation at dosing intervals of up to once every three weeks, in 2006 for renal anemia and 2009 for chemotherapy-induced anemia, which is a two year delay for the latter indication. On the day of news, February 1, shares in Amgen rose 6.5% to $77.60 in morning trading.

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