Sanofi-aventis Group enters agreement with Prasco Laboratories to market generic versions of ALLEGRA® (fexofenadine HCl)
Bridgewater, NJ
September 12, 2005
Sanofi-aventis announced today that its subsidiary Aventis Pharmaceuticals Inc. has signed a distribution and supply agreement with Prasco Laboratories to launch an authorized generic fexofenadine hydrochloride tablet in the United States. This generic product will be distributed in 30 mg, 60 mg and 180 mg formulations. Financial terms of the agreement were not disclosed.
This announcement follows a September 6, 2005 statement by Barr Pharmaceuticals and Teva Pharmaceuticals that they would be collaborating to launch a generic version of Allegra 30 mg, 60 mg and 180 mg.

Sanofi-aventis continues to believe that the generic products of Barr Pharmaceuticals and Teva Pharmaceuticals infringes its intellectual property rights, which are currently the subject of ongoing litigation with these two companies.  Sanofi-aventis will continue to vigorously defend its rights.

About Allegra Line of Products
The Allegra family of products provides patients with convenience and flexibility in treating their different seasonal allergy needs: Allegra 30 mg and 60 mg twice-daily; Allegra 180 mg once-daily; Allegra-D 12-Hour (fexofenadine HCl 60 mg/ pseudoephedrine HCl 120 mg) Extended-Release Tablets for twice daily dosing; and Allegra-D 24 Hour (fexofenadine HCl 180 mg/ pseudoephedrine HCl 240 mg) Extended-Release Tablets for once daily dosing.

The side effects with Allegra 180 mg for seasonal allergies are low and may include headache, cold or back pain. The side effects for Allegra 60 mg for seasonal allergies are low; less than 3% of people experience cold or flu, nausea, menstrual pain or drowsiness. The side effects for Allegra 30 mg are low and may include headache, cold, coughing or accidental injury.

Side effects with Allegra-D 12 Hour and Allegra-D 24 Hour were similar to Allegra 60 mg alone (headache, insomnia or nausea) and Allegra 180 mg alone (headache, cold or backache), respectively.  Due to the decongestant (pseudoephedrine) component in both Allegra-D 12-Hour and Allegra-D 24-Hour, these products must not be used if you:  are taking an MAO inhibitor (a medication for depression) or have stopped taking an MAO inhibitor within 14 days; retain urine; have narrow-angle glaucoma; have severe high blood pressure or severe heart disease.  Side effects with pseudoephedrine may include nervousness, restlessness, dizziness, or insomnia.  Headache, drowsiness, increased heart rate, palpitations, increased blood pressure, and abnormal heart rhythms have been reported.  You should also tell your doctor if you have high blood pressure, diabetes, heart disease, glaucoma, thyroid disease, impaired kidney function, or symptoms of an enlarged prostate such as difficulty urinating.

 

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.

Sanofi-aventis Group subsidiaries in the United States include Sanofi-Synthelabo Inc., Aventis Pharmaceuticals Inc. and Sanofi Pasteur Inc.

 

U.S. Contacts
Lisa Kennedy, 908-243-6361, lisa.a.kennedy@sanofi-aventis.com
Melissa Feltmann, 908-243-7080, melissa.feltmann@sanofi-aventis.com