Diet drug rimonabant (Acomplia / Zimulti) has been turned down for reimbursement by health insurance in Germany, the European Union's largest market, according to a decision by the German Ministry of Health published Jan. 11th in the official journal of the government.

The decision to classify Acomplia as a "lifestyle treatment" comes as a serious blow to manufacturer Sanofi-Aventis, which immediately announced that it intends to challenge the classification in German court.

Sanofi had contended that Acomplia should be covered under the German state health insurance program because in addition to promoting weight loss, it helps lower a person's risk for developing diabetes and heart disease.

The German regulatory body that decides which prescription medicines will be covered by German state health insurers, the Joint Federal Committee (G-BA), recommended that Acomplia be classified as a "lifestyle" drug in October.

Sanofi had been hoping that this decision would not be confirmed by the German Ministry of Health.

As a non-reimbursable drug, sales of Acomplia in Germany are likely to be far lower than if it was covered by the state health insurance program.

A month's supply of Acomplia in Germany was set by Sanofi at 80.32 Euros ($102), but if covered by state insurance, the co-pay would only have been about $10.

The German action was also being closely watched in a number of other larger European countries such as France, the UK and Italy, where no decision has yet been taken on coverage of Acomplia.

Only smaller European countries like Ireland, Sweden and Denmark have thus far agreed to provide coverage of Acomplia.