Biotech Values

[DewDiligence]

FDA Approves Roche’s Mircera

[Mircera is a long-acting erythropoietin that competes with AMGN’s Aranesp in Europe. However, a recent US court ruling found that Mircera infringes AMGN’s EPO patents, and Roche has said it won’t launch Mircera in the US “at risk.” Roche could appeal the lower-court ruling, but has not yet done so.]

http://www.reuters.com/article/marketsNews/idUKN1424046820071114

>>
Wed Nov 14, 2007 6:08pm EST

NEW YORK, Nov 14 (Reuters) - U.S. health officials have approved Roche Holding AG's anemia-fighting drug, Mircera, a Food and Drug Administration spokeswoman said on Wednesday.

But Roche has said it will not launch the drug in the United States after a Boston jury found the patents on Amgen Inc's (AMGN) top-selling anemia drugs to be valid.

The decision effectively blocks Mircera sales in the United States.

Roche -- which had expected a U.S. green light for Mircera -- has not yet decided whether to appeal the Amgen ruling, Roche CEO Franz Humer told the Reuters Health Summit in New York earlier this week.

The company could, alternatively, wait until Amgen's patents expire before launching its drug, Humer added.
<<