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