A new therapeutic advance for the prevention of atherothrombosis (heart attack, ischemic stroke, vascular death)

Sanofi announced today that clopidogrel bisulphate, a compound with a novel mechanism of action (platelet ADP receptor antagonist) discovered by Sanofi Research teams, has just obtained marketing approval from the European Commission, for "the reduction of atherosclerotic events (myocardial infarction, stroke, death due to vascular causes) in patients with a history of symptomatic atherosclerotic disease defined by ischemic stroke (from seven days until less than six months), myocardial infarction (from a few days until less than 35 days), or established peripheral arterial disease."

Codeveloped by Sanofi and Bristol-Myers Squibb, clopidogrel will be marketed in Europe by the two companies under the names Plavix® and Iscover® .The first European launches will take place as from July 1998.

The product has already been approved by the Food and Drug Administration and has been copromoted in the US by Sanofi and Bristol-Myers Squibb since March 1998 under the name Plavix® .

Approval has also been obtained from health authorities in Brazil, Chile and Russia.

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The Commission's decision to grant Plavix® marketing approval is primarily based on the results of the Caprie (Clopidogrel versus Aspirin in Patients at Risk of Ischemic Events) study, carried out on a population of more than 19,000 patients with a history of stroke, myocardial infarction, or symptomatic peripheral arterial disease.

Caprie demonstrated the innovative nature of clopidogrel, in that it is the first therapeutic agent to prove effective against atherothrombosis regardless of the vascular territory involved (cerebrovascular, cardiovascular or peripheral).

Clopidogrel provides a significant improvement in the prevention of myocardial infarction, stroke and vascular death in patients with symptomatic atherosclerosis (ischemic stroke, myocardial infarction, established peripheral arterial disease). Where aspirin prevents about a quarter of such events, clopidogrel prevents about a third.

The Caprie study also demonstrated clopidogrel's favorable tolerability, showing that patients treated with clopidogrel had a lower risk of severe gastro-intestinal hemorrhage than those treated with aspirin.

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In Europe and in North America, one person in ten over the age of 50 presents a history of myocardial infarction, stroke or peripheral arterial disease.

Stroke is the leading cause of invalidity and the third leading cause of death, whilst myocardial infarction is the leading cause of death in developed countries.

The co-development and marketing agreement between Sanofi and Bristol-Myers Squibb, initiated in 1993, concerns two compounds, clopidogrel and irbesartan. The clinical development of clopidogrel was conducted under the leadership of Sanofi and that of irbesartan under the leadership of Bristol-Myers Squibb. Both compounds will be marketed worldwide by Sanofi and Bristol-Myers Squibb.

With marketing approval for clopidogrel in Europe, Sanofi today sees further significant results from its considerable R&D efforts.