SANOFI-AVENTIS DISAGREES WITH GERMAN RECOMMENDATION ON ACOMPLIA

The German Federal Joint Committee has announced its decision on subsidizing sanofi-aventis' obesity drug Acomplia, recommending it be classified under Section 34 of the Social Code Volume, according to the company. Section 34 covers products viewed as lifestyle medications, which are not reimbursed by the German statutory health insurance.

This decision is pending final ratification by the Ministry of Health within two months. It becomes legally binding after publication in the Official Journal of the government. Sanofi-aventis said the proposed reimbursement classification of Acomplia is misplaced from a public health policy viewpoint.

Acomplia has been approved by the European Medicines Agency (EMEA) to treat obese patients with serious risk factors. Furthermore, while Acomplia is approved for use in concert with diet and exercise for the treatment of obese patients or overweight patients with associated risk factor, such as Type 2 diabetes or dyslipidaemia, the drug can help improve levels of HbA1c, HDL cholesterol and triglycerides, which is beyond treating of obesity alone. Therefore, sanofi-aventis doesn't believe the drug should be classified under Section 34, which is for products that are meant to improve quality of life in an otherwise healthy population.

The company also points out that the drug was recently granted reimbursement in Denmark for patients who have life-threatening obesity-related diseases and have not responded adequately to a weight reduction program. Should the German committee's decision be approved, sanofi-aventis intends to challenge the classification in court.