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Weight-loss pill will limit health risks, Sanofi says

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  • Weight-loss pill will limit health risks, Sanofi says

    SILVER SPRING, Maryland, June 14, 2007: Sanofi-Aventis told a U.S. advisory panel Wednesday that extremely overweight people need its new weight-loss pill to shed excess pounds and avoid the health risks associated with them.

    A third of Americans are considered obese and need more treatment options to get their weight down to a healthful level, representatives of Sanofi, which is based in Paris, told a panel of Food and Drug Administration advisers.

    The pill, which would be sold as Zimulti in the United States, was the first of a new class of drugs that block hunger signals in the brain and act directly on fat cells.

    The FDA has delayed a decision on the medicine three times out of concern that it may raise the risk of suicidal thoughts and actions. Sanofi is betting on U.S. approval to reach its goal of $3 billion a year in sales for the drug. The advisory panel will recommend Wednesday whether the benefits of slimming down outweigh the side effects of the product.

    "Obesity can be a painful condition on a daily basis," Pierre Rosenzweig, the vice president of international clinical development at Sanofi, said during the meeting in Silver Spring, Maryland. "Many patients are trying to lose weight but unfortunately most weight-loss interventions fail."

    U.S. citizens now spend $1 billion on weight-loss aids, and "90 percent is for dietary and herbal supplements, while only 10 percent is for FDA-approved substances," Rosenzweig said.

    Shares of Sanofi rose 31 cents to €67.26, or $89.39, in Paris. The stock has fallen 3.8 percent this year, more than the 2.9 percent drop in the 16-member Bloomberg European drug index.

    The French drug maker wants to market the medicine in the United States as a way for obese people to lose weight in conjunction with a healthful diet and exercise. Company executives say the drug is not for those just trying to fit into party clothes.

    U.S. regulators reviewing the company's application found that people who took Zimulti were twice as likely to have thoughts of suicide as people who took a placebo pill. Three patients taking the drug killed themselves during clinical trials, Sanofi officials said Wednesday. The drug is sold outside of the United States as Acomplia.

    The FDA asked its outside advisers to consider whether these data were enough to show that Zimulti caused psychiatric risks. The panel was also scheduled to vote Wednesday on whether the risks of the drug outweighed its benefits - reducing weight, cholesterol and blood sugar - in overweight people with an associated condition like diabetes or heart disease.

    "Obesity is a public health concern and the FDA may take the approach that the U.S. needs as many tools in the armory as possible," Stephen Pope, at Cantor Fitzgerald Europe in London, said on Tuesday. The FDA is expected to act on the Sanofi request by July 27.

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