Diet Pill Acomplia to Be Available in Germany in Late August

2 Aug 2006

The highly anticipated diet pill Acomplia (rimonabant), still stalled by unidentified issues at the U.S. Food and Drug Administration, will be available for purchase in Germany before the end of August, according to developer Sanofi-Aventis.

Hanspeter Spek, head of pharmaceutical operations, said Sanofi remains confident the FDA will approve Acomplia for sale in the United States before the end of this year, but as usual provided no details as to what has been holding it up since February.

"We are still hopeful and confident we can launch Acomplia before the end of 2006 in the U.S.," the ever-optimistic Spek said during a conference call with financial analysts.

A number of observers who have been hearing these optimistic pronouncements from Sanofi about the likelihood of early FDA approval for more than a year this time seemed a bit more skeptical about the prospects of Acomplia making it to the market in the United States this year.

"We believe the drug may not launch until sometime in the first half of 2007,'' Prudential analysts said in a note to clients two days ago. ``It may have to go up before an FDA Advisory Committee first, something we think investors may have lost sight of.''

Most FDA observers agree with that assessment, but at this point, the FDA advisory panel that would consider Acomplia has no meeting scheduled for that purpose between now and the end of the year.

Sanofi began selling the diet drug for the first time in Britain at the end of June, and Spek said "we have had a very, very positive first response from doctors in the U.K."

In addition to a launch in Germany in the next three weeks, Sanofi hopes to roll out the prescription weight-loss pill in about a half dozen other European countries during the remainder of the year.