FDA Advisory Committee Did Not Recommend Approval of Zimulti

On June 13 Sanofi-aventis announced that the U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee did not recommend approval of rimonabant (Zimulti®) to the US FDA for use in obese and overweight patients with associated risks factors.

Sanofi-aventis will continue to work closely with the FDA to address the committee's recommendations.

The FDA has set a PDUFA action date of July 26, 2007 for rimonabant.

Rimonabant is currently approved in 37 countries and is marketed in 18. In those countries where it is currently sold, the product is marketed as Acomplia®.

Rimonabant is the first and the most studied member of a new therapeutic class of drugs that selectively block the CB1 recemptors of the endocannabinoid systems (ECS), and the drug's development has deepened scientists' understanding of the ECS. When working normally, this system of receptors in the brain and throughout body (liver, muscle, abdominal, adipose tissue, gastro-intestinal tract and pancreas), among other functions, helps regulate food intake and how the body uses and stores fats and sugars. -Sanofi-Aventis