Paris (ots/PRNewswire)

- PLAVIX indication expanded to include patients with any acute
coronary syndromes (ACS) -

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Bristol-Myers
Squibb Company (NYSE: BMY) announced today that the European
Commission has granted a new indication for the antiplatelet agent
PLAVIX(R) (clopidogrel bisulfate) to include patients with ST-segment
elevation acute myocardial infarction (STEMI) who are eligible for
thrombolytic therapy.

STEMI is a severe heart attack in which an artery supplying the
heart with blood is generally blocked completely.(1) These blockages
are caused by clot formation in the coronary arteries, which is
associated with an underlying disease known as atherothrombosis.(2)
PLAVIX(R) is a prescription antiplatelet medicine taken once a day
that helps keep platelets in the blood from sticking together and
forming clots. PLAVIX(R) is approved for early and long-term risk
reduction in patients at risk for atherothrombotic events. The new
indication is based on the findings of two clinical trials that
treated patients who had STEMI with PLAVIX(R) administered on a
background of standard therapy, including acetylsalicylic acid (ASA).

"PLAVIX taken with ASA has previously been shown to reduce the
risk of death, recurrent heart attacks or stroke in patients with
unstable angina or less severe heart attacks," said Keith A.A. Fox,
Professor of Cardiology, University of Edinburgh, Scotland. "Now,
based on the results of two clinical trials, CLARITY-TIMI 28 and
COMMIT/CCS-2, clopidogrel has been approved by the European
Commission as showing benefit, together with ASA, in patients with
the most severe types of heart attacks. With this new guidance from
the European Commission, clopidogrel shows benefit in patients across
the spectrum of acute coronary syndrome."

There are approximately 10 million heart attacks per year
worldwide;(3) and 3 million are STEMI events.(4) In 2005, for the
United Kingdom, France, Germany, Italy and Spain, there were more
than 1 million acute coronary syndrome events, of which 25% were
STEMI.(7) Patients who have experienced STEMI are also at high risk
of another heart attack, stroke or death.(5)

The European Commission approval was based on the results of two
clinical trials in which STEMI patients were treated with PLAVIX(R)
taken with ASA and standard therapy. In the CLARITY-TIMI 28
(CLopidogrel as Adjunctive ReperfusIon TherapY -- Thrombolysis In
Myocardial Infarction Study 28) trial, patients were followed for 30
days.(6) In the COMMIT/CCS-2 (ClOpidogrel and Metoprolol in
Myocardial Infarction Trial) trial, patients were followed for 28
days.(3)

In the CLARITY-TIMI 28 trial, clopidogrel taken with ASA and other
standard therapy including fibrinolytics (clot-dissolving medicines)
reduced the odds of STEMI patients having another occluded artery, or
a second heart attack or death by 36 percent by day eight of
hospitalization or hospital discharge (event rate: 15.0% in
clopidogrel arm vs. 21.7% in placebo; P<0.001).(6)

Results of the COMMIT/CCS-2 trial demonstrated that in the 28 days
following randomization, clopidogrel, taken with ASA and standard
therapy, reduced the relative risk of death in STEMI patients by 7
percent (event rate: 7.5% vs. 8.1%; P=0.03), and reduced the relative
risk of MI, stroke or death by 9 percent (event rate: 9.2% vs. 10.1%;
P=0.02).(3)

"Survivors of STEMI events are at high risk of suffering another
event," said Professor Fox. "The results of the CLARITY-TIMI 28 and
COMMIT trials represent a major advance for patients who have had a
severe heart attack, and this indication for clopidogrel provides
clinicians with a new option for treating STEMI patients in order to
reduce their risk of heart attack, stroke or death."

In both trials, the rates of major bleeding and intracranial
hemorrhage were similar in both the PLAVIX(R) groups and the placebo
groups.(3,6)

PLAVIX(R) received approval for the STEMI indication by the U.S.
Food and Drug Administration on August 17, 2006.

The new STEMI indication reinforces the strong commitment of two
research and development pharmaceutical companies dedicated to
improving patient health.

About STEMI and Acute Coronary Syndrome

Acute ST-segment elevation myocardial infarction (STEMI) and
non-ST segment elevation myocardial infarction (NSTEMI), both
commonly together known as "heart attacks," along with unstable
angina are the three conditions classified as acute coronary syndrome
(ACS). PLAVIX(R) is indicated to reduce the risk of heart attack,
stroke, or death in all patients with ACS.

Examples of common symptoms of acute coronary syndrome include
persistent or "stabbing" chest pain or a heavy "pressure" sensation,
shortness of breath, numbness or tingling in the arm or neck, nausea,
pain in other parts of the body (back or stomach area), and others.

About Atherothrombosis

Atherothrombosis is the underlying cause of life-threatening
events such as heart attacks and ischemic strokes. It is a
progressive disease process, which begins with the unpredictable and
sudden rupture of an atherosclerotic plaque. The rupture of these
plaques activates platelets in the blood to form a clot (thrombus)
and it is these clots, which can partially or completely block
arteries, which may result in atherothrombotic events such as heart
attacks or ischemic strokes.(8)

About PLAVIX(R)

PLAVIX(R) also marketed as ISCOVER(R), was first authorized in the
European Union in 1998 and is also indicated for prevention of
atherothrombotic events in patients with myocardial infarction,
ischaemic stroke or established peripheral arterial disease and, in
combination with ASA, for the treatment of patients with non-ST
segment elevation acute coronary syndromes (unstable angina or
non-Q-wave MI).

PLAVIX(R) is a prescription antiplatelet medicine taken once a day
that helps keep platelets in the blood from sticking together and
forming clots. Since its initial approval on November 17, 1997, by
the U.S. Food and Drug Administration, PLAVIX(R) has been prescribed
to more than 52 million patients worldwide.(9)

The efficacy and safety profile of PLAVIX(R) have been established
through landmark clinical trials including more than 100,000
patients.

PLAVIX(R) has demonstrated early and long-term risk reduction for
patients at risk for atherothrombotic events in important clinical
trials. In the CURE trial, patients with unstable angina (UA) and
non-ST segment elevation myocardial infarction (NSTEMI) receiving
PLAVIX with ASA were followed for up to one year, 10 and in the
CAPRIE trial, patients with recent MI, recent ischemic stroke, or
established peripheral artery disease receiving PLAVIX alone were
followed for up to three years.(11)

PLAVIX(R) is marketed worldwide by sanofi-aventis (Paris Bourse:
EURONEXT: SAN; New York: NYSE: SNY) and Bristol-Myers Squibb Company
(NYSE: BMY) as PLAVIX(R) and ISCOVER(R).

About sanofi-aventis

Sanofi-aventis U.S. is the world's third largest pharmaceutical
company, ranking number one in Europe. Backed by a world-class R&D
organization, sanofi-aventis is developing leading positions in seven
major therapeutic areas: cardiovascular, thrombosis, oncology,
metabolic diseases, central nervous system, internal medicine, and
vaccines. Sanofi-aventis U.S. is listed in Paris (EURONEXT: SAN) and
in New York (NYSE: SNY).

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global pharmaceutical and related health
care products company whose mission is to extend and enhance human
life.

    References:
    1. American Heart Association/American College of Cardiology Scientific
       Statement. New guidelines emphasize need for speed when chest pain
       strikes.
       http://www.americanheart.org/presenter.jhtml?identifier=3022635.
       Accessed August 2006.
    2. Atherothrombosis.org. What is atherothrombosis?
       http://www.atherothrombosis.org/public/index.html.
       Accessed August, 2006.
    3. COMMIT (CIOpidogrel and Metoprolol in Myocardial Infarction Trial)
       collaborative group. Early intravenous then oral metoprolol in 45852
       patients with acute myocardial infarction randomised
       placebo-controlled trial. Lancet 2005; 366: 1622-32.
    4. American Heart Association. Heart Disease and Stroke Statistics
       2006 Update.
       http://circ.ahajournals.org/cgi/reprint/CIRCULATIONAHA.105.171600v1.
       Accessed August 2006.
    5. Steg GS, Goldberg RJ, et al. Baseline Characteristics, Management
       Practices, and In-Hospital Outcomes of Patients Hospitalized With
       Acute Coronary Syndromes in the Global Registry of Acute Coronary
       Events (GRACE). Am J Cardiol 2002;90: 358-363.
    6. Sabatine MS, Cannon CP, Gibson CM, et al. Addition of clopidogrel to
       aspirin and fibrinolytic therapy for myocardial infarction with
       ST-segment elevation. N Engl J Med 2005;352:1179-1189.
    7. IMS Health Acute Coronary Syndromes Analysis 2005.
    8. Viles-Gonzalez JF et al. Atherothrombosis: A widespread disease with
       unpredictable and life-threatening consequences. Eur Heart J 2004;
       25: 1197-1207.
    9. Data on file, sanofi-aventis.
    10. The Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial
        Investigators. N Engl J Med 2001;345:494-502.
    11. Bhatt DL, Chew DP, Hirsch AT, et al. Superiority of Clopidogrel
        Versus Aspirin in Patients With Prior Cardiac Surgery. Circulation.
        2001;103:363-368.

Web site: http://www.bms.com

Contact:

Brian Henry of Bristol-Myers Squibb, +33-1-58-83-69-38,
brian.henry@bms.com; Salah Mahyaoui of sanofi-aventis,
+33-1-53-77-40-31, salah.mahyaoui@sanofi-aventis.com