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Sanofi Says Everything Is “Going Exactly According to Schedule” for Acomplia

A top executive of Sanofi-Aventis Acomplia (rimonabant) , developer of the new anti-obesity drug Acomplia (rimonabant), said on November 8th that ” everything is going exactly according to schedule” for FDA approval in early 2006, even while conceding that no date has  Acomplia (rimonabant) yet been set for an advisory committee hearing on the novel drug.

Hanspeter Spek, Executive Acomplia (rimonabant) Vice President Pharmaceutical Operations, gave the very upbeat assessment to financial analysts in response to a question that followed a presentation on Sanofi’s third quarter 2005 results.

“ The action date of course is February 2006,” Speck said. ” I can just confirm that everything is going exactly according to schedule.

“ As fron the very beginning,  Acomplia (rimonabant) his is a project we always have developed in very very close collaboration with the FDA. Acomplia (rimonabant)  We are in a permanent dialogue. They give questions, we give answers.”

But Speck conceded that FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, which reviews and evaluates data concerning the safety and effectiveness of investigational drugs for use in the treatment of endocrine and metabolic disorders, has not yet notified it of plans to hold a meeting to consider Acomplia.

Virtually all  Acomplia (rimonabant) observers believe it highly unlikely that the FDA would approve a novel drug that is the first endocannabinoid-receptor inhibitor to be brought before it without any input from one of its advisory committees.

“ We have  Acomplia (rimonabant) no notification as of today, which makes it very unlikely that there will be an advisory board before the end of the year,” Speck said. “But there could still be an advisory board in January. We don’t know because we have not received a notification Acomplia (rimonabant)  And It is relatively useless to speculate about it.”

Acomplia (rimonabant) But Speck certainly radiated optimism about obtaining marketing approvals for Acomplia in the first half of 2006.

“ We are totally confident that this product will make it to the market in close collaboration with the American agency and of course also with the European agency,” he concluded.

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