New Large-Scale, Global Study Provides Additional Information About an Intensified Dose-Regimen of PLAVIX(R) in Acute Coronary Syndrome Patients Undergoing Angioplasty

Paris, and Princeton, New Jersey (ots/PRNewswire) -

-No added benefit on the composite primary end-point with the
higher dose when entire ACS study population considered-

-Important new findings with higher loading dose of PLAVIX(R) for
heart patients undergoing coronary angioplasty (PCI)-

Today, the OASIS study group will present initial results of the
CURRENT-OASIS 7 clinical trial at the European Society of Cardiology
congress in Barcelona. Sanofi-aventis (EURONEXT: SAN, and NYSE: SNY)
and Bristol-Myers Squibb (NYSE: BMY), co-commercialization and
co-development partners for PLAVIX(R) (clopidogrel bisulfate), were
sponsors of the study.

CURRENT-OASIS 7 is the largest clinical trial (25,087 patients)
to evaluate different dosing regimens of PLAVIX(R) plus aspirin in a
broad range of acute coronary syndrome (ACS) patients
(UA/NSTEMI/STEMI). The study was designed to assess the efficacy and
safety of an intensified clopidogrel regimen (600 mg loading dose day
1 / 150 mg days 2-7 / 75 mg days 8-30) versus the approved PLAVIX
dosage (300 mg loading dose day 1 / 75 mg days 2-30) for patients
managed with an early invasive strategy with an intent for
percutaneous coronary intervention (PCI).

The primary end-point (cardiovascular death, heart attack, or
stroke at thirty days) for the entire study population (including
subpopulations of patients that underwent PCI (70%) or not (30%)
examining the difference between the high-dose and standard-dose
PLAVIX(R) (clopidogrel bisulfate) regimens did not reach statistical
significance (4.2% vs. 4.4%, HR 0.95, p=0.37).

For clinically relevant subgroups that were pre-specified for
preliminary analyses, such as the PCI subgroup (70% of the trial
population, 17,232 patients), potentially medically relevant
differences in patient outcomes were observed. In this subgroup,
analysis showed an improvement in outcome for patients taking the
higher dose regimen (600 mg loading / 150 mg for days 2-7 / 75 mg
days 8-30) over the standard dose regimen (300 mg loading / 75 mg for
days 2-30), as shown by the reduction of the same composite end-point
of cardiovascular death, myocardial infarction and stroke by 15%
(4.5% vs 3.9%, p=0.037). In addition, analysis showed an important
42% relative risk reduction in definite stent thrombosis (1.2% vs
0.7%, p=0.001) with the higher dose regimen of clopidogrel over the
standard loading dose.

"An artery opening procedure with stent placement exposes a
patient to an increased risk of stent occlusion and subsequent heart
attack," said Doctor Jean-Pierre Lehner, Chief Medical Officer,
sanofi-aventis. "CURRENT-OASIS 7 provides important new information
about a high-dose regimen of PLAVIX(R) in ACS patients planned for
PCI. We are pleased to contribute to furthering the understanding of
patient care during the acute phase of coronary intervention."

The primary safety end-point was assessed by the stringent
bleeding definition of OASIS and while a significant increase in the
primary safety end-point of major bleeding with the high-dose
compared to the standard-dose PLAVIX(R) regimen was observed in the
overall trial population (2.5% vs 2.0%, HR 1.25, p=0.01) and the PCI
population (1.6% vs 1.1%, HR 1.44, p=0.006), there was no
statistically significant difference in intracranial bleeding or
fatal hemorrhage in the overall population and the PCI population.

Sanofi-aventis and Bristol-Myers Squibb believe that the
CURRENT-OASIS 7 data add to the broad clinical experience with
PLAVIX(R), which has been used in over 90 million patients during the
11 years it has been on the market.

About PLAVIX(R) (clopidogrel bisulfate)

Please see full prescribing information for the United States by
visiting www.PLAVIX.com. For the most updated PLAVIX(R) labelling
information in Europe please refer to:
http://www.emea.europa.eu/humandocs/PDFs/EPAR/PLAVIX/H-174-PI-en.pdf.

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company,
discovers, develops and distributes therapeutic solutions to improve
the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT:
SAN) and in New York (NYSE: SNY). For more information, please visit:
www.sanofi-aventis.com.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to extend and enhance human life. For more information,
visit www.bms.com.

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ots Originaltext: Sanofi-aventis; Bristol-Myers Squibb
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Ingrid Gorg-Armbrecht, Media, +33-153-774-625, Mobile:
+33-686-056-688, or ingrid.goerg-armbrecht@sanofi-aventis.com,
Sebastien Martel, Investors, +33-153-774-545, or
ir@sanofi-aventis.com, both of sanofi-aventis; Laura Hortas, Media,
+1-609-240-7025, or laura.hortas@bms.com , John Elicker, Investors,
+1-609-252-4611, or john.elicker@bms.com, both of Bristol-Myers
Squibb