FDA Approves Lovenox(R) (Enoxaparin Sodium Injection) for the Most Severe Type of Heart Attack

FDA Approves Lovenox(R) (Enoxaparin Sodium Injection) for the Most Severe Type of Heart Attack

May 18, 2007

Lovenox(R) is the Low-Molecular Weight Heparin, Approved in
the United States for the Broadest Range of Indications

    PARIS, May 18 /Xinhua-PRNewswire/ -- Sanofi-aventis
announced today that the Food and Drug Administration (FDA)
has approved a supplemental New Drug Application (sNDA) for
the anticoagulant Lovenox(R) (enoxaparin sodium injection)
for the treatment of patients with acute ST-segment
elevation myocardial infarction (STEMI). Lovenox(R) has
been shown to reduce the rate of the combined endpoint of
recurrent myocardial infarction or death in patients with
acute STEMI receiving thrombolysis and being managed
medically or with Percutaneous Coronary Intervention
(PCI).

    STEMI is a severe type of heart attack in which an
artery is generally completely blocked by blood clot for
sufficient time causing heart muscle damage.

    The FDA approval is based on the results of the
landmark ExTRACT-TIMI 25 trial (Enoxaparin and Thrombolysis
Reperfusion for Acute Myocardial Infarction Treatment,
Thrombolysis In Myocardial Infarction - 25 Study), which
included more than 20,000 acute STEMI patients and the
results of which were published in the April 6, 2006
edition of the New England Journal of Medicine.

    The ExTRACT-TIMI 25 study showed that in patients with
STEMI treated with fibrinolysis, enoxaparin significantly
reduced the rate of death or recurrent infarction at 30
days by 17% vs. unfractionated heparin (UFH) (9.9% vs.
12.0% p<0.001). This benefit of enoxaparin, as compared
to UFH, was observed both in patients who underwent
percutaneous coronary intervention within 30 days after
randomization or who where treated medically. The rates of
major bleeding (including intracranial hemorrhage) at 30
days were 2.1% in the enoxaparin group and 1.4% in the UFH
group (p<0.001). The 30 day rate of the composite
endpoint of death, myocardial nonfatal re-infarction or
nonfatal intracranial hemorrhage (a measure of net clinical
benefit) was significantly lower in the enoxaparin group as
compared to the unfractionated heparin group (10.1% vs.
12.2%, p<0.001).

    "The FDA approval is a significant milestone in
the evaluation of treatment options of patients with
STEMI," said Elliott Antman, M.D., Senior Investigator
TIMI Study Groups, Director, Samuel A. Levine Cardiac Unit
at Brigham and Women's Hospital, Professor of Medicine,
Harvard Medical School, and lead investigator of the
ExTRACT-TIMI 25 study. "With its new indication,
enoxaparin is now applicable across the full spectrum of
acute coronary syndrome conditions including unstable
angina or non-ST segment elevation myocardial infarction
(UA/NSTEMI) and ST-segment elevation myocardial infarction
(STEMI)."

    Sanofi-aventis has also submitted a dossier for the
STEMI indication in European countries including France,
Germany, UK, Italy and Spain.

    About Coronary Artery Disease and Acute Coronary
Syndrome

    Coronary artery disease (CAD) is the most common type
of heart disease globally, and is a serious health problem
worldwide. CAD causes approximately 17 million deaths per
year: the equivalent of one out of every three deaths
worldwide. According to the American Heart Association,
more than 13 million Americans have a history of CAD and
7.5 million have experienced an acute heart attack.

    Acute coronary syndrome (ACS) is an umbrella term used
to describe a group of clinical diagnoses caused by
narrowing of the coronary arteries and cover any group of
clinical symptoms compatible with acute myocardial
ischemia, caused by an imbalance between myocardial oxygen
supply and demand that results from CAD.

    Immediate treatment is required for all ACS. The
treatment approach is multifaceted and aims to try and
protect the affected heart muscle from further damage,
reinstate blood flow through the artery and reduce the
heart's demand for oxygen. In the emergency room, the
primary goals are to rapidly identify patients with MI
(STEMI), exclude alternative causes of chest pain, and
stratify patients into low- and high-risk groups and
provide appropriate therapy to minimize further damage or
ischemia to cardiac muscle.

    Restoration of blood to the heart (reperfusion) can be
achieved either via the use of certain drugs
(fibrinolytics), used to break down blood clots, or
mechanically by surgery (i.e. Percutaneous Coronary
Intervention (PCI)]. Pharmacological options for the
treatment ACS include the use of antiplatelet agents to
help prevent platelets from sticking together and forming
clots, and anticoagulants to prevent blood clotting.
Anticoagulants prevent clots from growing and new ones from
forming, but they do not dissolve clots.

    About Lovenox(R)

    Lovenox(R) is a unique chemical entity in a class of
antithrombotic agents known as low-molecular weight heparin
(LMWH). The number one selling low-molecular weight heparin
in the world, Lovenox(R) is obtained by alkaline
degradation of heparin benzyl ester and is about one-third
the molecular size of unfractionated heparin. Lovenox(R) is
the most widely studied LMWH, with 15 years of use in the
treatment of 130 million patients in 96 countries.

    Lovenox(R) is approved in the United States for the
prophylaxis of ischemic complications of unstable angina
and non-Q-wave (non-ST-segment elevation) myocardial
infarction when concurrently administered with aspirin and
for the prophylaxis of deep vein thrombosis (DVT) which may
lead to pulmonary embolism (PE); in patients undergoing
abdominal surgery who are at risk for thromboembolic
complications; in patients undergoing hip replacement
surgery (during and following hospitalization), in patients
undergoing knee replacement surgery; and in medical patients
who are at risk for thromboembolic complications due to
severely restricted mobility during acute illness; as well
as for the inpatient treatment of acute DVT, with or
without PE, when administered in conjunction with warfarin
sodium and for the outpatient treatment of acute DVT
without PE, when administered in conjunction with warfarin
sodium.

    About Deep Vein Thrombosis and Pulmonary Embolism

    Deep vein thrombosis (DVT) entails the formation of
blood clots within deep veins of the body, most commonly
occurring in the lower extremity. DVT occurs in up to two
million individuals in the United States each year.
Pulmonary embolism (PE), a serious complication of DVT, at
times fatal, is responsible for the death of approximately
300,000 people each year in the United States -- more than
breast cancer and AIDS combined.

    The main problem underneath DVT involves a blockage of
blood flow within the deep veins involved, owing to the
formation of a blood clot within. Symptoms of acute leg
pain and swelling may occur, as consequence of the blockade
to blood flow. A PE occurs when part of the blood clot
dislodges from its nest in the deep veins, and travels up
stream by way of the blood flow, eventually reaching the
lung, where it remains trapped. There are many symptoms
associated with PE, but the most common ones include
shortness of breath, lateral chest pain worsened by deep
breath in. There are well known risk factors to DVT,
including prolonged immobility, major surgery, chronic
medical ailments, cancer, age above 40 years, trauma, oral
contraceptives, pregnancy and the post-partum.

    The management of DVT includes prophylaxis, under
certain risk conditions, and acute treatment in patients
with a known DVT. The management of DVT involves several
treatments including early mobilization, anti-embolism
stockings or mechanical, leg-compression devices to enhance
blood flow, and anticoagulants and/or blood-thinning drugs.
It is important to consult your healthcare professional
about the signs and symptoms associated with DVT.

    About Sanofi-aventis

    Sanofi-aventis is one of the world leaders in the
pharmaceutical industry, ranking number one in Europe.
Backed by a world-class R&D organisation,
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 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 financial projections and estimates and their
underlying assumptions, statements regarding plans,
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"believes," "intends,"
"estimates," "plans" and similar
expressions. Although sanofi-aventis' management believes
that the expectations reflected in such forward-looking
statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to
various risks and uncertainties, many of which are
difficult to predict and generally beyond the control of
sanofi-aventis, that could cause 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 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, 2006. 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 more information, please contact:

    Philippe Barquet
    Tel: [phone]