The U.S. Health authorities approved Swiss pharmaceuticals producer Roche Holding AG’s anemia drug Mircera, but the company is still awaiting resolution of a patent case before launching the drug in the United States.
Mircera, which has been approved by the U.S. Food and Drug Administration for patients with anemia caused by kidney failure, is the subject of a legal tussle between Roche and rival Amgen Inc.
A U.S. District Court jury in Boston concluded last month that Roche's drug infringes 11 patents used in Amgen's best-selling Aranesp and Epogen drugs, which had combined sales of more than US$6 billion last year.
Roche is considering appealing the decision, but Amgen is already moving to bar the company from launching the drug and has said it will ask a Boston judge on Thursday to issue an official injunction to stop the sale of Mircera in the U.S.
With an injunction in place, Roche probably won't have a chance to sell the product in the U.S. until at least 2012, when the first patents on Amgen's anemia drugs expire.
Mircera is already sold in Austria, Sweden, Germany, Britain and Norway, Roche said.
William Burns, chief executive of Roche's pharmaceutical division, said the FDA's approval of Mircera is "another significant milestone" for the firm.
Mircera is the only FDA-approved medicine capable of stabilizing patients' hemoglobin levels with a single monthly or fortnightly dose, Roche said.
Shares in Roche were down 0.6 percent at 199.10 Swiss francs (US$177.31; EUR120.62) on the Zurich exchange.
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