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Sanofi-Aventis Provides Details on Acomplia


Posted on 2006-02-27 08:25:00



Executives of Sanofi-Aventis say they expect to launch their highly touted and greatly anticipated weight-management drug Acomplia during the second half of this year. But the future of Acomplia was clouded a bit when the Food and Drug Administration granted only conditional approval for the drug and outright rejected Sanofi-Aventis' bid to classify Accomplia as a stop-smoking treatment.

During an interview with analysts, executives at Sanofi-Aventis
said the FDA didn't ask for more clinical trials for Acomplia as a weight-management drug. Gerard Le Fur, senior executive vice president for medical and scientific affairs, said the FDA's rejection letter for Acomplia as a smoking-cessation treatment did contain a request for another clinical trial.

Le Fur refused to provide details, declined to say if the company would pursue the clinical trial and wouldn't say how long such a clinical trial would take. "We will meet with the FDA in the coming weeks," he said.

He and other executives continued to refer to the drug by its generic name, rimonabant, because Sanofi-Aventis hasn't received trademark clearance for the Acomplia brand name, Le Fur said. That will be one of the subjects to be discussed with the FDA, he said.

A second-half launch for Acomplia as a weight-management drug "is the most probable launch period we can estimate from today," added Hanspeter Spek, executive vice president for pharmaceutical operations. The company also plans to launch the drug in several European markets later this year, including Germany and the U.K.