FDA Clears Sanofi/B-MS' Plavix

Sanofi and Bristol-Myers Squibb have been granted clearance to marketPlavix (clopidogrel) by the US Food and Drug Administration for the reduction of atherosclerotic events (myocardial infarction, stroke, vascular deaths) in patients with atherosclerosis and recent MI, stroke, or established peripheral arterial disease.

This was the broad indication that the two companies were going for which, combined with B-MS' marketing muscle, should help to enhance its sales potential. Some analysts feel that clopidogrel has the potential to become a blockbuster drug, but only if further research provides the basis for making superiority claims over aspirin. Robert Fenichel, the FDA's deputy director of cardiovascular and renal drug products, said clopidogrel is marginally better than aspirin, but not enough to justify making comparative claims.

Despite the competition, Alex Zisson of Hambrecht & Quist predicts that clopidogrel could generate $350 million a year by 2001, and $500 million a year by 2002, if clear superiority over aspirin can be shown. A spokesman for the two companies said that clopidogrel is set to be launched in first-quarter 1998. While he did not disclose the price, it will certainly be much higher than aspirin.