[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.]
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. <<
Roche Holding AG is seeking a U.S. judge's clearance to sell an anemia treatment in the U.S. by offering a royalty to Amgen Inc. and proposing a selling price that is less than what Amgen charges for its top anemia drug.
Roche, of Basel, Switzerland, won U.S. regulatory approval for Mircera as a treatment for anemia associated with kidney disease in November. But it hasn't brought the drug to market in the U.S. because a federal jury in October found Mircera violated patents held by Amgen. Mircera went on sale in Europe last year.
Although Roche lost the patent trial, it sought permission from Judge William Young in Boston to bring Mircera to market by arguing that it would serve the public interest. Judge Young asked Roche to make a proposal to that effect. In a court filing Jan. 28, Roche proposed paying a royalty that is about double what Johnson & Johnson currently pays in order to market a version of one of Amgen's anemia drugs[Procrit].
Amgen isn't swayed. In a statement, the Thousand Oaks, Calif., company said: "Roche's product and marketing proposals confer no clinical benefit, serve no public interest and would actually increase the cost of treatment to Medicare, especially in the short term. Roche's belated royalty proposal is grossly inadequate to compensate Amgen for Roche's infringement and lacks any merit."
A ruling is pending on a request by Amgen for a permanent injunction to prevent Roche from selling the drug in the U.S.
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