Paris (ots/PRNewswire) - Sanofi-aventis announced today that the
anticoagulant Clexane(R) (enoxaparin sodium injection) has been
approved for marketing in Japan by the Ministry of Health, Labour and
Welfare for the prevention of venous thromboembolism (VTE) in
patients undergoing orthopaedic surgery of the lower limbs such as
total hip replacement, total knee replacement and hip fracture
Venous thromboembolism is a frequent and preventable complication
among patients hospitalized for orthopaedic surgery. Deep vein
thrombosis (DVT) and pulmonary embolism are common manifestations of
VTE and can significantly impact morbidity and mortality in surgical
patients. The Japanese VTE guidelines state that, without
prophylaxis, between 27% and 50% of orthopaedic surgery patients may
suffer from deep vein thrombosis. Among the hospitalised patients at
risk for VTE, 64% are those undergoing surgery(1).
"In Japan, Clexane(R) is expected to greatly contribute to the
prevention of venous thromboembolism and fulfil an important medical
need for patients undergoing orthopaedic surgery" said Hanspeter
Spek, Executive Vice-President Pharmaceutical Operations of
sanofi-aventis. "Clexane(R)'s approval illustrates the commitment of
sanofi-aventis to bring new life saving drugs to patients in Japan,
where further clinical trials are being conducted with Clexane(R) to
extend its use to abdominal surgery patients who are at risk for
venous thromboembolic complications" he added.
Outside Japan with over 200 million patients treated in more than
100 countries, Clexane(R) / Lovenox(R) (enoxaparin sodium) is the
most extensively studied and most widely used low-molecular-weight
heparin in the world. In venous thrombosis, Clexane(R) / Lovenox(R)
is recommended by international guidelines not only in orthopaedic
and general surgical patients at high and moderate risk of VTE, but
also for acutely ill medical patients, and is an important treatment
option for millions of patients at risk of VTE(2). In arterial
thrombosis, Clexane(R) / Lovenox(R) has demonstrated its
effectiveness in preventing, in conjunction with other treatments,
the ischaemic complications of unstable angina and myocardial
infarction and is also recommended by international guidelines(2).
About Clexane(R) / Lovenox(R)
The no. 1 selling low-molecular weight heparin in the world,
Clexane(R) / Lovenox(R), is a unique chemical entity in a class of
antithrombotic agents known as low-molecular weight heparins (LMWH).
Its clinical applications are linked to its antithrombotic
properties. It is used to inhibit clot formation in venous and
arterial vessels to prevent potential acute or chronic complications
of venous or arterial thrombosis.
The recommended dose regimen of Clexane(R) in Japan is 20 mg b.i.d
subcutaneous and has been established with the results of Japanese
Enoxaparin sodium is known by the brand name Lovenox(R) or
Clexane(R) or Klexane(R) and its labelling may vary country to
About venous thromboembolism (VTE)
Venous thromboembolism is a general term used to describe the
formation of a blood clot (thrombus) that blocks a vein. This may
occur in any part of the venous system, but the most common
manifestations are deep-vein thrombosis (DVT), usually in the leg,
and pulmonary embolism (PE). PE is a potentially life-threatening
complication of DVT; anyone who experiences DVT is at risk of a PE,
which occurs when part or all of a blood clot in a deep vein breaks
away from where it originally formed and travels through the venous
circulation, eventually becoming lodged in the lungs. This blocks the
flow of blood in the lungs and is often fatal.
The total annual burden of non-fatal symptomatic VTE in the
European Union, which included DVT and PE, is estimated to exceed 1.5
million events, including more than 500,000 deaths(3). This
represents more than the double of the combined deaths due to AIDS,
breast and prostate cancer and transport accidents(4).
In the United States, up to 2 million DVT events occur each year,
and the development of PE causes up to 200,000 deaths annually(5).
Fatal PE is the leading cause of sudden death among hospitalized
patients and contributes to up to 10% of in-hospital deaths(6).
In Japan, the population survey report by the Ministry of Health,
Labour and Welfare showed that annual number of deaths from PE had
sharply increased between 1988 to 2001 (591 to 1749 deaths).
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
PARIS: SAN) and in New York (NYSE: SNY).
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,
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differ materially from those expressed in, or implied or projected
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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 labeling 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, 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. Cohen AT et al. A large-scale, global observational study of
venous thromboembolism risk and prophylaxis in the acute hospital
care setting: the ENDORSE study. Abstract Ndegrees 1827,
International Society on Thrombosis and Haemostasis, Geneva, 8 July
2. The seventh ACCP conference on Antithrombotic and Thrombotic
Therapy. Chest. 2004.
3. Cohen AT on behalf of the VTE Impact Assessment Group in Europe
(VITAE). Venous Thromboembolism (VTE) in Europe: The number of VTE
events and associated morbidity and mortality. Thromb Haemost
4. Eurostat statistics on health and safety 2001. Available from:
5. Coalition to Prevent Deep Vein Thrombosis. Available at
http://www.preventdvt.org/ Accessed June 28, 2007.
6. Nicolaides AN, Fareed J, Kakkar AK, et al. Prevention and
treatment of venous thromboembolism. International Consensus
Statement. (Guidelines according to scientific evidence). Int
ots Originaltext: sanofi-aventis Group
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