Entire US panel censures drug after suicides
Sanofi drops $9bn after diet pill veto
June 15, 2007
By Angela Cullen and Catherine Larkin
Frankfurt - The market value of Sanofi-Aventis plunged more than $9 billion (R65 billion) in Paris yesterday after a US panel blocked the French pharmaceutical giant's new diet pill because it was linked to suicides.
Zimulti did not get a single favourable vote from a Food and Drug Administration (FDA) panel, which found that the weight lost did not justify the danger of psychiatric or neurological side effects.
The stock fell as much as 8.5 percent, the steepest decline since September 2 2002 and the biggest destruction of value since Aventis was incorporated into Sanofi-Synthelabo in 2004. At noon in Paris, it was at €62.02 (R597.90), down €5.24 on the day.
The third-largest drug firm was counting on US approval to lift the pill's sales to $3 billion a year, but the FDA is now likely to ban Zimulti, sold as Acomplia in Europe, after three trial patients committed suicide.
"This is a major setback," said Laurent Vallee, an asset manager at Richelieu Finance. "Acomplia was [expected to] become a blockbuster. Sanofi needs a new growth driver."
Analysts at HSBC Securities, Merrill Lynch, ABN Amro and Societe Generale reduced their ratings after the decision.
The FDA usually follows the recommendations of its panels. Sanofi expects the agency to rule on the drug by July 26 after delaying a decision three times because of safety concerns.
The Paris-based drug maker said yesterday that it planned to "work closely with the FDA to address the committee's recommendations".
Analysts said further clinical trials might delay US sales until at least 2009. Acomplia sales hit €31 million last year.
The pill would be the first of a new class of drugs that block hunger signals in the brain and act directly on fat cells. Some Americans are not waiting for FDA approval and are travelling to Europe or cyberspace to buy the medicine.
The FDA noted that taking one 20mg pill a day resulted in significant weight loss.
US regulators found that people who took the drug were twice as likely to have thoughts of suicide as those who took a placebo. Three patients on the drug killed themselves during clinical trials, Sanofi officials said. A fourth suicide reported after the drug went on the market had not been confirmed.
FDA panel member Jules Hirsch, a professor at the Laboratory of Human Behavior and Metabolism in New York, said: "There's a reasonable suspicion that we'd better learn some more and watch this affair very carefully before we launch into use of the drug."
Pharmaceutical firms have not introduced a new weight-loss pill in the US since Roche's Xenical won FDA approval in 1999, while herbal remedies like hoodia have been thriving.
Sedentary lifestyles and fatty diets have caused the number of obese Americans to double during the past 30 years.
"This is a serious health problem, and we don't have many good treatments" falling between dieting and surgery, said Louis Aronne, a New York-based obesity specialist who has consulted for Sanofi.
He said the FDA was under pressure to be strict on safety after legislators said it failed to alert the public to heart risks of diabetes drug Avandia and painkiller Vioxx. - Bloomberg
|
|
