Menu

Press Releases

RIMONABANT ACCEPTED FOR FILING BY THE FDA
Paris, France
June 23, 2005
Sanofi-aventis announced today that the United States Food and Drug Administration (FDA) has accepted for filing the company’s New Drug Application (NDA) for rimonabant, the first agent in a new therapeutic class known as selective cannabinoid type 1 (CB1) blockers.

Rimonabant, discovered and developed by sanofi-aventis, is thought to represent a new approach for the comprehensive management of cardiovascular risk factors. The compound has been studied to date in over 6,500 overweight and obese adults for up to 2 years.

Despite therapeutic advances in recent decades, cardiovascular disease remains the leading cause of mortality worldwide. Current treatments generally target risk factors individually, rather than providing a comprehensive management approach to such cardiovascular risks as dyslipidemia, abdominal obesity and insulin resistance, which comprise the metabolic syndrome.  

As the first selective CB1 blocker, the effects of rimonabant on lipid and glucose metabolism, insulin resistance and reduced intra-abdominal adiposity, evidenced by a reduction in waist circumference, have been studied.  Abdominal obesity is recognized as a significant risk factor in the development of cardiovascular disease.  

Rimonabant also has been studied by sanofi-aventis as an aid to smoking cessation based on studies for up to one year in over 6,500 smokers motivated to quit smoking.

A Marketing Authorization Application to the European Medicines Agency (EMEA) for rimonabant has also been submitted.

 

About sanofi-aventis

The sanofi-aventis Group is the world’s third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. The sanofi-aventis Group 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.  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 and expectations with respect to future operations, products and services, and statements regarding future performance.  Forward-looking statements are generally identified by the words “expect,” “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, 2004.  Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

The sanofi-aventis Group conducts its business in the United States through its subsidiaries Sanofi-Synthélabo Inc., Aventis Pharmaceuticals Inc. and Sanofi Pasteur Inc.

 

Contact
Jean-Marc Podvin, 33 1.53.77.42.23, jean-marc.podvin@sanofi-aventis.com