Sanofi-Aventis, developer of Acomplia (rimonabant), told financial analysts on Jan. 30th it is "very, very confident" it will be permitted to begin selling the highly anticipated weight-loss drug in the United States in the spring of this year.

"We can only report that our collaboration with the FDA is excellent. We have developed the product in very, very close cooordination," Hanspeter Spek, executive vice-president of pharmaceutical operations said on a conference call.

"Now, of course, we are preparing for the upcoming launch of Acomplia," Spek said. "We remain very, very confident we will be able to launch the product in the second quarter of 2006."

As a further indication of Sanofi's optimism, the company has set up a conference call to brief selected journalists on Acomplia on February 2.

The U.S. Food and Drug Administration still has not given any indication when it might act on Sanofi's application to market Acomplia, or whether it will approve the drug for any indications other than weight-loss.

Many analysts would be very surprised if the agency acts before the drug is considered by an FDA advisory committee. The panel that would consider it, the Endocrinologic and Metabolic Drugs Advisory Committee, has a meeting tentatively scheduled for May, but has yet to indicate it expects to take up Acomplia at that time.

In the briefing, Sanofi did not provide an update on where the Accomplia approval process stands with European regulators.