OSI Pharmaceuticals (OSIP) - formerly Oncogene Message Board

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Biotech / Medical : OSI Pharmaceuticals (OSIP) - formerly Oncogene

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To: tom pope who wrote (256)	7/28/2006 11:57:10 AM
From: tuck	of 447

After getting approved by the FDA for first line pancreatic cancer, Tarceva flames out in the EU for that indication: >>10:40AM OSI Pharm announces that Roche has received negative C.H.M.P opinion in european union on tarceva in pancreatic cancer (OSIP) 33.38 -0.40 : Co announces that Roche, its international partner for Tarceva (erlotinib), received a negative opinion from the European Committee for Medicinal Products for Human Use, regarding approval of Tarceva in combination with gemcitabine chemotherapy as first-line, once-daily, oral therapy for locally advanced, inoperable or metastatic pancreatic cancer. Roche is evaluating its options - including a possible request for re-examination of the decision. << From Briefing.com. Folks may remember that Tarceva in combo with Gemzar added a couple of weeks survival, but that more strokes were observed in the combo arm versus Gemzar monotherapy. The ODAC and FDA apparently decided to let docs make the call on the risk/benefit of the combo, the CHMP did not. Whatever, as Merrill said, the revenue impact seems marginal, either way. As such the Street seems unworried, as OSIP is actually up on the news today. Cheers, Tuck

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