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	12/5/2008 12:33:07 PM
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Merrill Tarceva expansion still key to growth, pipeline is long-term The R&D day showed that Tarceva label expansion remains the key potential growth driver while other oncology and diabetes/obesity candidates are in early stage development (see pipeline chart). Separately, we lowered our P.O. to $44 from $48 on weak market conditions. Maintain Neutral. Expects to file SATURN data in 1H09 OSIP is working through the SATURN data which met the primary endpoint in the NSCLC (non-small cell lung cancer) maintenance setting but we await the details to assess clinical importance. OSIP expects to file for label expansion in 1H09. Oncology and diabetes/obesity pipeline early stages We find OSIP-906, an oral inhibitor of IGF-1R (insulin growth factor-1 receptor) in three phase l trials for solid tumors, and PSN-821, an oral G-protein coupled receptor agonist in phase l development interesting but they are in early stages. Tarceva ANDA with paragraph IV expected OSIP noted that we could see an ANDA (abbreviated new drug application) filing against Tarceva’s composition of matter ‘498 patent (expires 2018) in the next few months, which would likely prompt a patent infringement lawsuit (would take several years to resolve, in our view). (see details in note). Maintain Neutral We maintain our Neutral rating as the competitive landscape for Tarceva is sorted out in NSCLC and US scripts remain flattish. We look for any upticks if the detailed SATURN data is clinically meaningful. Separately, we lowered our P.O. to $44 (17x ‘09e EPS $2.59 (excl. any accounting changes, see note) from $48.

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