Further updating . . .
>>MELVILLE, N.Y.--(BW HealthWire)--Nov. 26, 2001--OSI Pharmaceuticals, Inc. (NASDAQ: OSIP - news) today provided investors with an extensive update of the Company's progress in its research and development programs at OSI's inaugural research day for the investment community. The presentations at today's event, held in New York City, were also made broadly available via webcast and can continue to be viewed at www.osip.com through December 7, 2001. Highlights of the meeting were as follows:
The Company provided a summary of the acquisition announced earlier today, of oncology assets from Gilead Sciences. OSI will, upon closing of the transaction, acquire rights to three clinical compounds from Gilead: NX211, a liposomal formulation of the topoisomerase I inhibitor lurtotecan that is currently in Phase II clinical trials for refractory ovarian and small cell lung cancer; GS7836, a nucleoside analog with activity in multiple solid tumor xenograft models which is being developed as a next-generation gemcitabine, and is currently in Phase I trials; and GS7904L, a thymidylate synthase inhibitor, just entering Phase I trials for a variety of solid tumors.
A summary was also provided of the Company's overall research and development capabilities. As part of the OSI /Gilead transaction, OSI will also acquire infrastructure and assume operations of Gilead's Boulder, Colorado facility and retain an outstanding drug development and oncology clinical operations team. This acquisition, together with OSI's established expertise in drug discovery, provides OSI with a team of over 350 research and development professionals comprising a comprehensive array of capabilities and expertise in small molecule drug discovery and development, principally in the oncology area.
OSI also announced the return of full commercial rights to CP-609,754, a farnesyl transferase inhibitor (FTI) that was undergoing Phase I trials with Pfizer Inc. CP-609,754, was jointly discovered by OSI and Pfizer as part of their long standing alliance in cancer drug discovery and was being developed by Pfizer as a targeted therapy for use in major solid tumor indications (colon, lung, etc.). The K-ras oncogene and other farnesylated signal transduction proteins are considered the gene targets for anti-cancer activity in these tumors, however competitor products have not demonstrated significant anti-tumor activity in these major tumor populations. FTIs are designed to function as anti-cancer agents by preventing key signaling proteins like those in the ras family from associating with the cell membrane in cancer cells. Pre-clinical studies have shown that the FTIs are relatively ineffective at blocking the cell membrane association of K-ras in human tumors, but are more effective at blocking the membrane association of H- and N- forms of the ras gene. OSI announced plans to develop CP-609,754 for tumors such as bladder cancer where mutant and over-expressed forms of the H-ras oncogene are present. There are 55,000 incidences of bladder cancer diagnosed each year in the United States, though a niche market for many major pharmaceutical companies, OSI recognizes the opportunity to develop CP-609,754 to address a significant unmet medical need. Rights were returned to OSI according to terms of the license agreement between OSI and Pfizer covering the development of drug candidates emanating from the OSI / Pfizer discovery alliance that concluded in April, 2001. OSI will pay a royalty to Pfizer if the drug is successfully developed.
The Company also provided an updated summary of its clinical pipeline in oncology following today's announcements. Upon the closing with Gilead, OSI will have a total of six small molecule anti-cancer products in clinical development. The most advanced of these is Tarceva(TM), OSI's anti-EGFR inhibitor which is in Phase III clinical trials for refractory and front-line non small cell lung cancer and front-line pancreatic cancer. The next most advanced product is NX211, which is scheduled to complete ongoing Phase II trials for refractory ovarian and small cell lung cancer in 1Q/ 2Q 2002. OSI-754 (CP-609-754), GS7836 and GS7904L, all in Phase I clinical trials, will now be developed as proprietary OSI products. Finally, CP-547,632, a potent and selective VEGFR tyrosine kinase inhibitor is in Phase I trials with Pfizer.
``We are pleased to have had this opportunity to share our vision and progress with the investment community,'' stated Colin Goddard, Ph.D., Chairman and Chief Executive Officer. ``We set the goal for 2001 of building both our clinical pipeline behind Tarceva(TM) and those areas of expertise where we had under-developed skill sets. We believe that we can now point to an organization that possesses excellence in drug discovery and development from concept to registration and an emerging pipeline that positions OSI as a major force in oncology.''<<
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Cheers, Tuck |
