OSI Pharmaceuticals (OSIP) - formerly Oncogene Message Board

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

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From: tom pope	6/15/2006 10:00:50 AM
	of 447

ML, from yesterday: Encouraging early data for PSN9301 in type 2 diabetes OSI Pharmaceuticals presented encouraging data from a phase IIa proof-ofconcept study for its oral DPP-IV inhibitor, PSN9301, in the treatment of type 2 diabetes at the ADA (Amer. Diabetes Assoc) annual meeting. The oral DPP-IV inhibitors as a class received much attention at ADA, and pursuant to licenses to its intellectual property, OSIP will receive a 2.5% royalty on sales of the drugs. PSN9301 is part of OSIP’s proprietary DPP-IV program. Maintain Buy. Short study shows significant reduction in glucose PSN9301 is a fast-acting small molecule DPP-IV inhibitor meant to be given prior to meals, in contrast to other DPP-IV inhibitors in development that are dosed once or twice a day. In the randomized double-blind placebo-controlled two-week trial, 56 patients with type 2 diabetes received 240 mg, 360 mg or 480 mg of PSN9301 three times daily with meals. The data showed that the glucose area under the curve in response to an oral glucose tolerance test was reduced 24 - 42% compared to placebo. No serious adverse events were reported. Expect to move into phase IIb in 3Q06. OSIP expects to move PSN9301 into a phase IIb trial in 3Q06. We would expect the study to be at least 12 weeks in duration with an endpoint of Hb AIC reduction, the benchmark of efficacy in the treatment of type 2 diabetes. We would look for data from this study in 2007. In the meantime, we expect FDA decisions on Merck’s DPP-IV inhibitor, Januvia, in October and on Novartis’ Galvus in November 2006. OSIP will derive royalties on these products if approved.

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