Plavix(R) Indications Expanded in Japan to Include Patients with Acute Coronary Syndrome for Whom Percutaneous Coronary Intervention Is Being Planned

Geschrieben am 22-10-2007

Paris (ots/PRNewswire) -

Sanofi-aventis announced today that the Japanese Ministry of
Health, Labor and Welfare (MHLW) has granted approval for a
Supplemental New Drug Application (sNDA) for the indication of "Acute
coronary syndrome (unstable angina pectoris, non-ST elevation
myocardial infarction) for which percutaneous coronary intervention
(PCI) is being planned" for Plavix(R) (clopidogrel).

Approximately 100,000 patients develop an acute coronary syndrome
(ACS) and elect to undergo PCI every year in Japan -- where Plavix(R)
is now the first drug approved in this indication --, the largest
number of patients in the world outside of the United States. "We are
pleased that the innovative therapy, Plavix(R) is now available to
physicians in Japan, offering them a new treatment option with proven
outcomes and safety across ACS patients with planned PCI," said
Hanspeter Spek, Executive Vice-President Pharmaceutical Operation of

In Japan, this new cardiology (ASC) extension completes the recent
approval (May 2006) in the reduction of recurrence of stroke for
which the 2 weeks-prescription-only-limitation has been lifted in May
2007, as result of the favorable one year safety assessment.

The efficacy and safety profile of Plavix(R) is well established
in multiple large-scale Japanese and international landmark clinical
trials involving more than 100,000 patients as well as from real-life
clinical experience in more than 70 millions patients worldwide
including Japan.

Japanese guidelines(1,2) suggest that Plavix(R) can fill an
important medical need for patients with UA-NSTEMI. Outside Japan,
Plavix(R) is also recommended in multiple national and international
guidelines (US [ACC/AHA] and European [ESC]) (3,4,5,6,7,8) for ACS,
heart attack, recent MI, stroke and/or P.A.D patients at risk for
future atherothrombotic events as a standard treatment for millions
of patients at cardiovascular risk.

Outside Japan, Plavix(R) is the only widely approved antiplatelet
agent used in monotherapy for prevention of atherothrombotic events
in patients with recent myocardial infarction (hear attack), recent
ischaemic stroke or established peripheral arterial disease, and in
combination with acetylsalicylic acid for the treatment of patients
with acute coronary syndrome (unstable angina or NSTEMI) including
those who are to be managed medically and those managed with PCI
(with or without stent) and for STEMI patients.

Plavix(R) is one of the most studied cardiovascular medications
available to patients with short and long term clinical benefit, and
after a decade of prescriptions, it remains the oral antiplatelet
therapy with the broadest range of indications worldwide.

About Plavix(R)

Plavix(R), also marketed as Iscover(R), is an antiplatelet agent
which prevents platelets from sticking together and forming clots in
the arteries. Plavix(R) was first authorized in the United States in
1997 and the European Union in 1998 and has been prescribed to more
than 70 millions patients worldwide.

In Japan, in addition to the new approval for acute coronary
syndrome (unstable angina pectoris, non-ST elevation myocardial
infarction) for which percutaneous coronary intervention (PCI) is
planned, Plavix(R) is also approved for "reduction of recurrence
after ischemic cerebrovascular disorder (excluding cardiogenic
cerebral embolism)" one of the 3 major causes of death in Japan.

The efficacy and safety profile of Plavix(R) have been established
through landmark clinical trials including more than 100,000 patients
worldwide. Outside Japan, Plavix(R) has shown favourable tolerability
profile as compared to ASA and an acceptable increase in major
bleedings when used in combination with ASA (no statistical
difference when only PCIs are considered).

In Japan, Plavix(R) is marketed by sanofi-aventis K.K. Plavix(R)
is marketed in more than 100 countries by sanofi-aventis (Paris
Bourse: EURONEXT: SAN; New York: NYSE: SNY) and BMS (NYSE: BMY).

About Acute Coronary Syndrome

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

Unstable angina, non-ST segment elevation myocardial infarction
(myocardial infarction which does not show ST elevation in ECG), and
acute myocardial infarction are considered to be the series of the
pathological condition referred to as acute myocardial ischemia as
the clinical syndrome. These three symptoms and sudden cardiac death
are collectively referred to as acute coronary syndrome.

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. 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 Atherothrombosis

Atherothrombosis is the underlying cause of life-threatening
events such as heart attacks and ischemic stroke. It is a progressive
disease process in which there is an unpredictable and sudden rupture
of an atherosclerotic plaque. The rupture, fissure or erosion of
these plaques activates platelets in the blood to form a clot
(thrombus) and which can partially or completely block arteries,
resulting in atherothrombotic events.

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 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.

1 Guidelines for Management of Acute Coronary Syndrome without Persistent
ST segment Elevation (JCS 2002, Circulation Journal Vol.66, Suppl. IV.
2002, pp.1123-1163)
2 Guidelines for management of anticoagulant and antiplatelet therapy in
cardiovascular disease (JCS 2004, Circulation Journal Vol.68, Suppl.
IV, 2004, pp.1153-1219)
3 The American College of Cardiology/The American Heart Association
4 ACC/AHA 2007 Guidelines for the Management of Patients With Unstable
Angina/Non-ST-Elevation Myocardial Infarction: Circulation 116: 803 -
877, 2007
5 The American College of Cardiology/The American Heart Association/The
Society of Cardiovascular Angiography and Interventions
6 ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary
Intervention: Circulation 113(7): e166 - e286, 2006
7 The European Society of Cardiology
8 Guidelines for the diagnosis and treatment of non-ST-segment elevation
acute coronary syndromes: Eur Heart J. 28(13): 1598-1660, 2007

Web site: http://www.sanofi-aventis.com

ots Originaltext: sanofi-aventis Group
Im Internet recherchierbar: http://www.presseportal.de

Philippe Barquet, +33-6-70-48-61-28, for sanofi-aventis; Media
Relations, +33-1-53-77-44-50, media-relations@sanofi-aventis.com, or
Investor Relations, +33-1-53-77-45-45, IR@sanofi-aventis.com, both of


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