Sanofi's Acomplia hits buffers in Germany

The German medical and health fund committee, which monitors the drug sector, has recommended classifying Sanofi-Aventis' anti-obesity drug Acomplia (rimonabant) as a so-called "comfort" drug - thus effectively lining it up with treatments for nicotine addiction and erectile dysfunction.

This means that Acomplia will not be reimbursed by the Germany's statutory health insurance, the Krankenkasse. The Ministry of Health has 60 days in which to respond to the recommendation, but the committee's verdict is a blow for the French group. If the Ministry confirms the recommendation, Sanofi-Aventis has said it will be forced into the courts.

The company is arguing that the decision conflicts with that of the European Medicines Agency (EMEA) which gave European Union-wide marketing approval in the summer (Marketletter July 3). This indicated, according to Sanofi-Aventis, that the proven effect of the drug in clinical trials on cholesterol, triglycerides and sugars, as well as weight reduction, was fully recognized. The German decision is a setback in that Acomplia is far and away the company's most promising drug product.