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Acomplia moves closer to European launch

CHMP opinion recognises positive effects of sanofi-aventis drug on serious risk-factors

Sanofi-aventis' promising anti-obesity pill, Acomplia (rimonabant), is on track for a 2006 launch after a panel of European Medicines Agency (EMEA) experts gave the drug its backing.

The agency said its Committee for Medicinal Products for Human Use (CHMP) had recommended Acomplia as an adjunct to diet and exercise for obese or overweight patients with associated risk factors, such as Type 2 diabetes or dyslipidaemia, an abnormally high level of cholesterol in the blood.

The recommendations still have to be endorsed by the European Commission, which usually delivers a marketing authorisation within two to three months.

In a statement, sanofi said it expects to begin selling Acomplia in Europe in the second half of the year. It will be available as a 20mg tablet to be taken once daily.

Particularly good news for the French firm is that the CHMP has recommended that Acomplia's European label note the drug's positive effects on serious risk-factors such as cholesterol and blood-glucose levels.

ìThis is really good news as it is an acknowledgment that the product has a favourable efficacy-risk ratio and that investors' recent uncertainties on the tolerability of the product were not justified,î commented analyst, Jean-Jacques Lefur at French brokerage, Oddo Securities.

ìWe should only use this drug in such patients where there is a real medical need, and not in people who may seek to use it for cosmetic reasons,î said Professor Luc Van Gaal, who headed a European clinical trial of Acomplia.

There is no drug in sanofi's pipeline that is more important to the firm; analysts have forecast annual global sales of $3.5-5bn if Acomplia is approved in the US and Europe. The EMEA said it had approved two brand names for the drug - Acomplia and Zimulti - but a sanofi spokesman said the company planned to use the name Acomplia in Europe.

sanofi suffered a setback in February after the US Food and Drug Administration (FDA) declined to approve Acomplia.

sanofi had been hoping to market the potential blockbuster as a treatment for both obesity and smoking. The company received a so-called 'approvable' letter for the drug as a weight loss treatment, and a 'not approvable' letter for use as a smoking cessation drug.

The 'not approvable' letter effectively ended sanofi's chances of entering the lucrative smoking cessation market with Acomplia.

30th September 2008

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