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Biotech / Medical : OSI Pharmaceuticals (OSIP) - formerly Oncogene -- Ignore unavailable to you. Want to Upgrade?


To: tuck who wrote (151)5/14/2002 1:08:21 PM
From: tuck  Respond to of 447
 
>>SOUTH SAN FRANCISCO, Calif., May 14 (Reuters) - Genentech Inc. (NYSE:DNA - News) and OSI Pharmaceuticals Inc. (NasdaqNM:OSIP - News) said on Tuesday that U.S. regulators gave their experimental Tarceva lung cancer drug fast track approval status.

The designation means the U.S. Food and Drug Administration will review the product in an expeditious manner because the the drug is intended to treat a serious or life-threatening disease. The designation also usually means the drug demonstrates the potential to address unmet needs for such a condition.

The companies are seeking approval for the drug to treat a form of lung cancer. Tarceva is a small molecule EGFR inhibitor being developed by Genentech, OSI and Roche Holding Lt. (ROCZg.VX).

"Lung cancer remains one of the most devastating forms of cancer, with a five-year survival rate of only 3 percent for patients with metastatic disease," said Susan Hellmann, Genentech's executive vice president and chief medical officer.

"Designation of Tarceva as a fast track product recognizes the seriousness of the condition and unmet medical need in lung cancer," she said.<<

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Cheers, Tuck