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Biotech / Medical : VD's Model Portfolio & Discussion Thread

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To: Cytokine1 who wrote (9352)	8/20/2002 11:54:50 PM
From: Vector1	Read Replies (2) of 9719

WHY WE BOUGHT OSIP IMO the IRESSA study leads me to conclude that the likelihood of success for Tarceva in the front line lung cancer combo trial with chemo is low but not out of the question. From what I have read the OSIP/DNA study is powered to meet its end point with a 25% increase in survival whereas the AZ IRESSA study required a 33% improvement. In addition the drugs are not exactly the same and metabolize differently. On the other hand the AZ management was very negative on the conference call leading me to believe there was virtually no survival benefit whatsoever. That is a surprising result but that is why they do the studies. I think you have to assume that given the similarities of the drugs Tarceva has to be heavily discounted in the large combo trial. However, more importantly, OSIP/DNA is conducting two other stand alone studies which are imo are not being taken into full consideration and I believe have a high likelihood of success. OSI is conducting a trial in late stage lung cancer in Canada with about 330 patients who are refractory to at least 1 but no more than 2 prior chemotherapies. Patients will be randomized 2:1 to receive Tarceva monotherapy (150 mg/day) or placebo and will be evaluated for survival (primary endpoint) and response rates and quality of life (QoL)improvements (secondary endpoints). Placebo studies in late stage cancer are highly unusual for obvious reasons. The mean survival time for these patients is 4-6 months. The trial is powered so that a 50% improvement in median survival (6-8 months) would likely meet an FDA approval endpoint given the relatively mild toxicity of the drug. Given Tarceva's results in the phase IIs I think they have a good chance of success in this study. In addition OSI is running a Pancreatic Cancer trial with Tarceva in combo with Gemzar. The endpoint is improvement in survival. The median survival with Gemzar alone is 5.7 months. My reasons for hope on this is that pancreatic cancer is known to be highly dependent on EGFR overexpression, with 90%of cases expressing the receptor. Moreover, Imclone's Erbitux plus Gemzar has a 13% response in pancreatic cancer. If these trials are successfull then Tarceva is a $500m plus cancer drug and its 5-10x from here. Thats my view amd why I bought OSIP. V1

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