Study Shows Otamixaban Substantially Reduced Complications of Invasive Management of Acute Coronary Syndromes

Paris (ots/PRNewswire) -

- SEPIA-ACS Multiple-dose Phase II Results Showing 27- 42% Risk
Reduction in ACS Complications Presented in Plenary Session of
European Society of Cardiology Congress and Published in The Lancet

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that
the investigational anti-Xa intravenous anticoagulant otamixaban
reduced by 27 to 42 percent the odds of the composite primary
endpoint of death, myocardial infarction, urgent revascularization or
rescue GPIIb/IIIa use in 4 out of the 5 otamixaban tested doses,
versus standard UFH/eptifibatide combination in [non-ST] ACS patients
suitable for invasive strategy. The results of the SEPIA-ACS1/
TIMI-42 were presented today at the plenary session of the Annual
European Society of Cardiology congress in Barcelona and
simultaneously published online in The Lancet.

Otamixaban is a first in class, rapid onset antithrombotic
compound, acting as a direct selective inhibitor of factor Xa.
Otamixaban is originating from Sanofi-aventis world-class thrombosis
research portfolio and is currently in phase IIb clinical development
phase.

"The data show that intermediate dosages of otamixaban may offer
substantial reduction in major coronary complications in patients
presenting with acute coronary syndrome, with bleeding rate
comparable to current therapy," said Dr Marc Sabatine, MD, MPH, an
Investigator in the TIMI Study Group and a cardiologist at Brigham
and Women's Hospital, Harvard Medical School. "This research is
addressing an important medical need, by potentially significantly
improving outcomes of ACS patients undergoing PCI while simplifying
the treatment pattern of the acute management phase of the disease."
he added.

The double-blind phase II SEPIA-ACS1/ TIMI-42 study randomized
3241 patients from 36 countries in 6 treatment arms. The study
assessed the efficacy and safety of five different doses of
otamixaban versus the standard unfractionated heparin plus
Glycoprotein IIb/IIIa inhibitor (eptifibatide), on background of
standard dual antiplatelet therapy, in patients with high-risk
non-ST-elevation acute coronary syndromes. SEPIA-ACS1 study showed
that otamixaban displayed clinically meaningful activity on the
primary endpoint from the threshold dose of 0.070 mg/kg/h, the second
tested dose, with a consistent antithrombotic effect up to the 5th
highest tested dosage. The lowest studied dosage was prematurely
stopped due to insufficient activity, based on recommendation by an
independent data monitoring board. Moreover a combined analysis of
the intermediate doses (0.105 and 0.140 mg/kg/h) of otamixaban arms
showed that otamixaban reduced by approximately 46 percent (p=0.0198)
the risk of the composite of death or a second myocardial infarction,
a predefined study secondary efficacy endpoint.

The potent antithrombotic effect of otamixaban was also
accompanied with a dose-dependent bleeding profile. Combined
intermediate otamixaban dosages showed a safety profile not
statistically different with regard to TIMI major or minor bleeding
through 7 days, in comparison to UFH and GPIIb/IIIa inhibitor
comparator (RR 1.20, 95% CI 0.64-2.27, p=0.5634).

"The SEPIA-ACS1 trial is providing very encouraging results for a
new and more effective treatment approach," said Marc Cluzel, MD
Senior Vice President Research and Development Sanofi-aventis. "We
aim, on the basis of these findings to address through our
development program remaining patients', practionners' and payers'
needs for management of ACS."

Acute Coronary Syndromes is a general term used to regroup
clinical symptoms related to acute myocardial ischemia. ACS
represents an area of important medical need, as despite use of
several antithrombotic therapies, death and myocardial infarction
still occur in 5 to 8% of patients in the following week after an
initial event.

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).

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ots Originaltext: sanofi-aventis Group
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