Clexane(R)/Lovenox(R) Approved in Japan
28/01/2008 08:05
PR Newswire
PARIS, January 28 /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
surgery.
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 clinical
trials.
Enoxaparin sodium is known by the brand name Lovenox(R) or Clexane(R) or
Klexane(R) and its labelling may vary country to country.
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).
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 PARIS: 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,
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 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 2007.
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 2007;98:756-76.
4. Eurostat statistics on health and safety 2001. Available from:
http://epp.eurostat.cec.eu.int.
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 Angiology. 2006;25(2):101-161.
Contact: Philippe Barquet: +33-6-70-48-61-28