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Paris, France - December 21, 2009
Sanofi-aventis provides an R&D Pipeline update
- CHMP Positive opinion for DuoPlavin® in Cardiology.
- FDA Fast Track designation with Rolling Submission obtained for Cabazitaxel in Prostate Cancer.
- Discontinuation of Development for Eplivanserin in Insomnia.
- Discontinuation of Development for Idrabiotaparinux in Atrial Fibrillation.
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today an update of its R&D pipeline for four of its projects: DuoPlavin® in cardiology, cabazitaxel in oncology, eplivanserin in insomnia and idrabiotaparinux in thrombosis.
On December 17, 2009, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) adopted a positive opinion, recommending to grant a marketing authorisation for DuoPlavin®, a new fixed combination of clopidogrel hydrogen sulphate and acetylsalicylic acid. The drug is indicated for prevention of atherothrombotic events in adult patients with acute coronary syndrome who are already taking both clopidogrel and acetylsalicylic acid (ASA). The benefit with DuoPlavin® is its simplification of treatment.
The Food and Drug Administration (FDA) has granted a fast track designation allowing a rolling submission of a New Drug Application (NDA) for cabazitaxel in second-line prostate cancer. This rolling submission has already started. A rolling submission is an FDA provision that allows for completed sections of a New Drug Application to be submitted on an ongoing basis.
The primary endpoint of the Phase III TROPIC study, which was overall survival, met statistical significance. The results of this study will be presented at the next ASCO GU cancers congress (American Society of Clinical Oncology – Genito-Urinary) in March 2010.
The company has ongoing discussions with the EMEA regarding the European Union submission for cabazitaxel.
Further to the complete response letter issued by the FDA in September 2009, and considering the needs for significant further clinical developments and market access constraints, the eplivanserin submission dossier in insomnia will be withdrawn in the United States and in Europe.
In the BOREALIS trial, idrabiotaparinux was developed for the prevention of thromboembolic events in patients with atrial fibrillation. Considering recent therapeutic advances in this field, this compound does not appear able to bring significant improvement in the care of these patients. Therefore, the development in this indication is discontinued.
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: SAN) and in New York (NYSE: SNY). For more
information, visit: www.sanofi-aventis.com.
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