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Roche Won’t Launch EPO Knockoff ‘At Risk’

http://www.reuters.com/article/marketsNews/idUKL1649236920071016

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Roche says U.S. Mircera plans depend on court case

Tue Oct 16, 2007 12:58pm EDT

ZURICH, Oct 16 (Reuters) - Swiss drugmaker Roche Holding AG said on Tuesday that it will not attempt to launch its anemia drug Mircera in the United States if it loses a patent battle with rival Amgen Inc (AMGN).

"If across the waterfront Amgen prevails, then that probably blocks us from launching," William Burns, chief executive of Roche's pharmaceuticals business, said on a conference call with analysts. "So it will be rather crystal clear from that point of view."

Roche and Amgen, the world's biggest biotechnology company, are battling it out in U.S. District Court in Boston, and a jury is set to begin deliberating later this week on whether Mircera infringes patents on Amgen's anemia drugs Aranesp and Epogen.

"Roche management confirmed that their U.S. launch plans are completely contingent on the outcome of their patent litigation with Amgen in Boston," said Geoffrey Porges, an analyst at Sanford Bernstein, in a report. "For the first time, they confirmed that they would not launch at risk if Amgen prevails in the patent case."

In patent disputes, drug companies sometimes launch their products, even while the dispute is ongoing on the bet they will eventually prevail.

Roche is seeking to win approval for Mircera from the U.S. Food and Drug Administration. It is already approved in Europe. Burns said the drug, if approved, will likely have a similar label to that in Europe.

"The labeling discussions are underway, the FDA signaled mid-November as an action date, and I am thoroughly encouraged," Burns said."

If Roche prevails in the court, it will launch Mircera, even if Amgen appeals, he said.
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