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



    
    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
    

    PARIS, Aug. 30 /CNW/ - 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).

    Forward Looking Statements

    This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended. Forward-looking
statements are statements that are not historical facts. These statements
include product development, product potential projections and estimates and
their underlying assumptions, statements regarding plans, objectives,
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Forward-looking statements are generally identified by the words "expects,"
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actual results and developments to differ materially from those expressed in,
or implied or projected by, the forward-looking information and statements.
    These risks and uncertainties include among other things, the
uncertainties inherent in research and development, future clinical data and
analysis, including post marketing, decisions by regulatory authorities, such
as the FDA or the EMEA, regarding whether and when to approve any drug, device
or biological application that may be filed for any such product candidates as
well as their decisions regarding labelling and other matters that could
affect the availability or commercial potential of such products candidates,
the absence of guarantee that the products candidates if approved will be
commercially successful, the future approval and commercial success of
therapeutic alternatives as well as those discussed or identified in the
public filings with the SEC and the AMF made by Sanofi-aventis, including
those listed under "Risk Factors" and "Cautionary Statement Regarding
Forward-Looking Statements" in Sanofi-aventis' annual report on Form 20-F for
the year ended December 31, 2008. Other than as required by applicable law,
Sanofi-aventis does not undertake any obligation to update or revise any
forward-looking information or statements.




For further information:

For further information: Media Contact: Sanofi-aventis, Salah Mahyaoui,
Tel: +33-1-53-77-40-31, Mobile: +33-6-73-68-78-88, Email:
salah.mahyaoui@sanofi-aventis.com

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