Three trial patients committed suicide, after testing the drug 'zimulti' sold in Europe as 'Acomplia.' resulting, in non approval from the FDA, who found the loss of weight did not justify, the danger of psychiatric or neurological side effects.
The market value of Sanofi-Aventis dropped more than $9 billion in Paris yesterday, after it was blocked by the US panel. Zimulti did not get a single favourable vote from the Food and Drug Administration's panel.
The FDA will now probably ban the pill, even though the third largest drug firm was relying on US approval to lift sales $3 billion a year. Their stock dropped by 8.5 percent, with the company facing the biggest decline since September 2002. It is the biggest destruction of value since Aventis was incorporated into Sanofi-Synthelabo in 2004.
Asset manager, Laurent Vallee at Richelieu Finance said,
"This is a major setback. Acomplia was expected to become a blockbuster. Sanofi needs a new growth driver."
The FDA has delayed in making a decision three times because of safety concerns. It usually follows the recommendations of it's panel, and Sanofi are expecting the agency to rule on the drug by July 26.
Further analysis and clinical trials, could delay US sales until 2009, at the least. Last year Acompli reached sales of thirty one million pounds.
It was found by the US regulators that people who took the drug were twice as likely to have thoughts of suicide than those who took a placebo. Three people have committed suicide while on the trials, while a fourth suicide has not been confirmed.
FDA panel member Professor Jules Hirsch from 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 companies have not introduced a new weight loss pill since 1999, and this drug claims that hunger signals in the brain would be blocked and would act directly on fat cells.
Taking one 20mg pill a day results in significant weight loss, causing some, to travel to Europe or Cyberspace to buy this new drug.
