Summary
This is a severe blow for the company which is now forced to consider external growth, but is not expert in out-of-France acquisitions. Rimonabant was meant to become THE sanofi-aventis blockbuster for the next 5 years at least. Also, the R&D productivity at sanofi-aventis will be questioned, since so little information filtered out of the Company about the potential risks of rimonabant not being approved. For other centrally-acting product for peripheral conditions such as obesity/cardiometabolic disorders, FDA and EMEA will be even more severe and restrictive in the future.
Analysis
For sanofi-aventis, this is an adverse event of major importance. The Company was so convinced that rimonabant would be approved that the FDA Committe 14-0 vote (+ severe comments by Committee Members) is earth-shattering.
One can expect serious troubles inside sanofi-aventis, incl. at highest management echelons.
In order not to become a prey, after having been a successful predator for more than 20 years (albeit only in France), sanofi-aventis will seriously revisit its external growth activities, since Lovenox, Plavix and Ambien are at risk of losing important sales this year, adding to the rimonabant dismay.
A light of hope lies with the Vaccines business, which is buoyant, but only 10% of overall sales.
