Sanofi-Aventis shares dive after FDA panel rejects weight-loss drug Accomplia

PARIS (AP) - Shares of French pharmaceutical company Sanofi-Aventis plunged Thursday as investors reacted to U.S. federal health advisers’ rejection of the company’s Accomplia weight-loss drug. The Food and Drug administration’s advisory panel turned down the drug, also known as rimonabant and Ziumlti, after hearing testimony that it increases the risk of suicidal thoughts, even in patients without a history of depression. Sanofi-Aventis failed to show the drug is safe, the FDA panel said Wednesday. The unanimous votes by the 14-member expert panel made it unlikely the FDA will approve

the drug, which blocks certain brain receptors that regulate appetite. The agency usually follows its panel’s advice, but it is not required to do so. In a statement, Sanofi said it would “continue to work closely with the FDA to address the committee’s recommendations.” Shares closed down 6.3 per cent at US$83.71 as the decision by the FDA panel triggered a wave of broker downgrades for Sanofi earnings and the group’s share price. Paris-based Exane, Morgan Stanley, JP Morgan, Oddo and Deutsche Bank lowered their target prices with recommendations ranging from $79.72 to $107.62.

With Acomplia’s future in the United States looking doubtful, analysts also raised concerns over possible repercussions in Europe, where the anti-obesity drug was approved last year. Sanofi-Aventis reported sales of $20 million in the first quarter of 2007 for the drug. More than 130,000 people have used the treatment since it was launched. Citigroup analysts said European sales of the drug might be at risk due to the safety concerns about suicide risk. A panel of experts from the European Medicines Agency will meet next week to examine Acomplia’s new safety data as part of the regulator’s routine monitoring, a spokeswoman said Thursday. The uncertain future for Acomplia raises pressure on the French drug maker to make acquisitions to boost its drug portfolio. “Sanofi-Aventis is the third-largest pharmaceutical company in the world, but has relatively few growth drivers. Acomplia was the most important pipeline product,” said Nomura Code analyst Paul Diggle, who has a reduced recommendation on the stock.As a result, speculation of a possible tie-up between Sanofi-Aventis and its U.S. marketing partner Bristol-Myers Squibb Co. is likely to resurface. Jean-Marc Podvin, a spokesman for Sanofi-Aventis, declined to comment on the company’s acquisition plans.