A senior executive at Sanofi-Aventis told analysts that he couldn't give a timeline for the introduction of its blockbuster anti-obesity drug Acomplia in the U.S., raising doubts about exactly when it could be approved. Executive Vice President Hanspeter Spek said that the FDA was not requiring new trials for Acomplia but that he couldn't say if the drug would be ready for the U.S. market in six months. Earlier, Sanofi had told analysts that FDA approval could come by the end of this year--a fast fading prospect for the world's third largest drug maker. Analysts now are looking to mid-2007 for an approval, with the prospect of new delays ahead. The drug is designed to reduce a person's urge to overeat. It is approved in six European countries and analysts peg potential annual sales at $3 billion.
- read this report [1] on Sanofi from the International Herald Tribune
Related Articles:
EMEA committee recommends Acomplia of obesity. Report [2]
Sanofi touts Acomplia for diabetes. Report [3]
Links:
[1] http://www.iht.com/articles/2006/10/31/business/drug.php
[2] http://www.fiercebiotech.com/story/emea-committee-recommends-acomplia-of-obesity/2006-04-28
[3] http://www.fiercebiotech.com/story/sanofi-touts-acomplia-for-diabetes/2005-06-13