
New York (That Happened!) - The pharmaceutical company Sanofi-Aventis has announced that it has decided to suspend all clinical trials that are currently being conducted with rimonabant, marketed as Acomplia, a drug designed to combat obesity.
In a statement, the company has made public its decision to end “all programs in clinical development” of the drug CP-945,598.
The decision of the company has adopted “as a result of recent requests from some national health authorities.”
Last October, the European Medicines Agency requested the suspension of the authorization process of the drug, believing that its risks outweigh its benefits.
The company has announced that they will inform health professionals about this decision.
“While confident in the safety of the compound, we believe that this is the appropriate decision based on all available information regarding this class of agents, as well as recent discussions with regulatory authorities,” Pfizer research chief Martin Mackay said in a statement.
The drug company has stressed that this announcement does not change the group’s prospects for 2008. Rimonabant was approved in Europe in 2006 to treat obesity and its attendant risks in combination with diet and exercise.
“This will significantly affect the perception of their (future) revenues,” but the companies could overcome that with replacement drugs down the road, said analyst Steve Brozak of WBB Securities.
The drug, which acts on brain receptors related to appetite, thus became the third antiobesidad drug on the market, after orlistat and sibutramine. This authorization was, however, conditional on a surveillance post sales of the product designed to assess the risks that had psychiatric related to the drug.
In fact, the listing of the drug has already been tightened several times since it is on the market for the label to warn users of possible risk of depression and psychiatric disorders arising from its use, and warn of some contraindications. For these same reasons, the U.S. has not received approval from the Agency of the drug.
In trading Wednesday, Pfizer shares fell $1.09, or 6 percent, to $17, while U.S.-traded Sanofi-Aventis shares fell $2.40, or 7.5 percent, to $29.69.
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