ROCHE MOTION TO DISMISS AMGEN LAWSUIT DENIED

The U.S. District Court for the District of Massachusetts has denied Roche's request to dismiss a patent lawsuit brought by Amgen and also denied a motion for Ortho Biotech to intervene as a co-plaintiff in the case, according to Amgen.

Amgen believes that Roche's peg-EPO product, CERA (continuous erythropoiesis receptor activator), violates Amgen's patents and does not provide any clinical or patient benefit over its anemia treatments Epogen (epoetin alfa) and Aranesp (darbepoetin alfa), Amgen said.

Amgen will likely issue a preliminary injunction motion if the FDA approves Roche's CERA, Merrill Lynch analyst Eric Ende said in an Oct. 24 research note. Ende said Roche maintains it will launch CERA if the FDA approves the drug.

"Whether the FDA approves CERA is an open question, but with a trial not until September, we would expect Amgen to move for a preliminary injunction to prevent its launch." However, preliminary injunctions are difficult to obtain, he noted.

As of now, a trial is expected in September 2007, Ende said, adding that this date will likely be delayed due to the nature of patent litigation.