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Amgen patents infringed, jury rules

Stock surges after decision against Roche anemia drug


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Amgen officials can breathe a bit easier about the future of the company's anemia drugs after a Boston jury determined that a competing medication violates 11 of Amgen's patents.

The jury ruled Tuesday that Roche's Mircera, an anemia drug now undergoing Food and Drug Administration review, infringed on Amgen's patents related to anemia drugs. The Thousand Oaks-based biotech company has two anemia drugs on the market, Epogen and Aranesp.

The decision was a clear victory for Amgen, though mostly an expected one after a judge determined in August that Mircera infringed upon a key Amgen patent, said Eric Schmidt, an analyst with Cowen and Co.

He said it now seemed unlikely that Mircera would ever be available on the U.S. market.

Amgen investors celebrated the win on online discussion groups, and the company's stock surged $1.58 to $57.70 Tuesday.

Amgen said in a statement that the company is pleased with the verdict and plans to seek an injunction to keep Roche from bringing Mircera to market in the U.S. The injunction hearing is scheduled for Nov. 15.

Roche said FDA approval was expected Nov. 14.

Roche declared Tuesday that it was looking at its legal options, including the possibility of appeal, and maintained that Amgen's patents are invalid and not infringed.

"The jury's verdict is disappointing because it is a loss for U.S. patients with chronic kidney disease who are being deprived of the opportunity to benefit from options in the management and treatment of renal anemia," George Abercrombie, president and chief executive of Hoffman-La Roche Inc., said in a statement. "We believe it is important for there to be competition and choice in this country."

Hoffman-La Roche is the prescription drug unit of Roche.

The Swiss company's argument was that Mircera offered patients fewer doses a month, compared with Amgen and Johnson & Johnson's anemia drugs. Amgen has maintained that the Roche drug did not provide a clinical or patient benefit over Amgen's anemia drugs.

The court decision came just before Amgen's third-quarter earnings conference call, which is today after the market closes.

Schmidt said it is nice to cross the Mircera challenge off the list for Amgen, but the company has other, more substantial challenges.

"This issue has been secondary or even tertiary to the greater concerns around ESA (anemia drug) safety," he said.

That is the big issue that Amgen has been struggling with ever since studies raised concerns about the safety of anemia drugs. That led to the FDA putting strong warning labels on anemia drugs and changes in how Medicare pays for the drugs. Both have led to a significant drop in sales of Amgen's top drug, Aranesp.

The reduced revenue led to Amgen's restructuring program, which has included an indefinite halt to construction of the company's manufacturing site in Ireland as well as voluntary buyouts and layoffs.

Schmidt expects an update on the restructuring during today's conference call, though he said it is probably too early for concrete financial guidance.

On the Net:

www.amgen.com

www.rocheusa.com

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