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

Paris (ots/PRNewswire)

- Lovenox(R) is the Low-Molecular Weight Heparin, Approved in the
United States for the Broadest Range of Indications
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,
objectives, intentions and expectations with respect to future
events, operations, products and services, and statements regarding
future performance. Forward-looking statements are generally
identified by the words "expects," "anticipates," "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.
Contact:
    Philippe Barquet
    +33-6-70-48-61-28

Contact:

Contact: Philippe Barquet, +33-6-70-48-61-28

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