Amgen, Roche submit Mircera responses

Amgen (NASDAQ:AMGN) and Roche (SWX:ROG) submitted briefs to the U.S. District Court for the District of Massachusetts, which is considering modifying a preliminary injunction to enable Roche to sell Mircera methoxy polyethylene glycol-epoetin beta under certain stipulations. Roche believes it can satisfy the court's stipulations, and Amgen is seeking a permanent injunction. The court is expected to make a final decision by April 1.

The court would allow U.S. marketing of the drug if Roche agrees to pay Amgen a 22.5% royalty rate; sell Mircera at an average selling price equal to or less than that of Amgen's Epogen epoetin alfa; provide evidence of clinical usage and the real-world dosage of Mircera; fund an independent agency to monitor sales and royalty payments; and continue to provide the drug to any patient who requests it at or below the same price for which it was authorized. Roche said it will deliver a detailed plan by the court's deadline at the end of May. ...