Roche asks for clearance to bring Mircera to market

BASEL, Switzerland Roche is asking a U.S. judge for clearance to sell an anti-anemia drug by offering a royalty to Amgen and offering the drug at a price that is lower than what Amgen charges for its top anemia drug, according to published reports.

Roche won regulatory approval for Mircera as a treatment for anemia associated with kidney disease in November. But it hasn't brought the drug to market because it lost a civil trial in October in which a federal jury found Mircera violated patents held by Amgen. Amgen sells drugs Aranesp and Epogen to treat anemia associated with kidney disease and cancer chemotherapy.

Although Roche lost the patent trial to Amgen, it is now seeking permission from Judge William Young to bring Mircera to the market by arguing that it would serve the public interest. Roche also has proposed selling Mircera at an initial "wholesale acquisition cost" that is about 5 percent less than the current "average selling price" of Amgen's Aranesp. Also, it would pay Amgen a royalty 20 percent of net sales of Mircera while Amgen's patents are still enforced, assuming the original ruling of infringement stands.

Roche said it would begin taking steps to market Mircera if the judge doesn't rule on Amgen's injunction request on Feb. 28, when oral arguments are scheduled in the case. Roche would be doing this even though they would be at risk to pay Amgen penalties if the infringement case isn’t overturned.

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