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Executive Summary

BRISTOL-MYERS SQUIBB/SANOFI/STERLING WINTHROP CARDIOVASCULAR COLLABORATION would cover the development and marketing of Sanofi Pharma's clopidogrel and SR 47436. Under a preliminary agreement jointly announced June 1, the companies will share the development programs, with Bristol-Myers Squibb leading the development of SR 47436, an angiotensin II receptor antagonist, and Sterling Winthrop and Sanofi continuing to take the lead in the development of the antithrombotic/oral anti-platelet agent clopidogrel. Definitive agreements are expected "within several months," BMS and Sanofi/Sterling Winthrop said. The preliminary agreement also allows for joint consideration of the development of other products "at a later date." Sanofi will receive royalty payments. Clopidogrel hydrogen sulfate is in Phase III trials worldwide under the auspices of Sterling Winthrop and Sanofi. Potential indications for the drug include prevention of second heart attack, transitory ischemic attacks, stroke and peripheral arterial disease. Clopidogrel follows on Sanofi's first anti- platelet agent ticlopidine, which is marketed in the U.S. by Syntex as Ticlid. As part of clopidogrel's development program, the drug is being studied in the Clopidogrel v. Aspirin in Patients at Risk of Ischemic Events (CAPRIE) program, which, Sanofi says, is designed to show the "superior benefit/risk ratio of clopidogrel over aspirin for the prevention of recurrent attacks of all manifestations of atherosclerosis." The CAPRIE program will eventually involve 15,000 patients at 170 centers in the U.S. and Canada, 130 clinical trial sites in Europe and 30 in Australia and New Zealand. Sterling Winthrop Pharmaceuticals Research Division President Eugene Cordes told analysts last December that clopidogrel is Sterling's biggest effort in terms of clinical resources. The massive Phase III clinical trials program, Cordes explained, is designed to demonstrate clopidogrel's superior efficacy to 325 mg aspirin with a comparable safety profile ("The Pink Sheet" Dec. 21, 1992, p.18). SR 47436 is entering Phase II trials in the U.S. and is in Phase II in Europe. Bristol-Myers Squibb said that the angiotensin II inhibitor "is expected to offer advantages over several types of drugs now available to treat hypertension." Under the preliminary agreement, marketing of clopidogrel and SR 47436 will be handled on a country-by-country basis "and may include comarketing, copromotion and joint venture entity marketing," BMS and Sanofi/Sterling Winthrop said. Sanofi Pharma said June 1 that "initial filings for regulatory approval are expected in 1996." Commenting on the preliminary BMS deal, Sanofi Pharma said: "The strategy thus implemented, in addition to the optimization of risks and costs, will increase the opportunities of bringing the greatest possible number of innovative compounds from the Sanofi Winthrop Alliance's research organization to the international marketplace, through other collaborative agreements of this type." Sanofi added that the "agreements also provide for a means of favoring Sanofi Winthrop's short-term growth through the licensing of products" from BMS to Sanofi Winthrop "in some European markets."

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