Posted by jrbecker on April 11, 2005, at 9:06:03
In reply to FDA Issues Approvable Letter for AMBIEN CR, posted by jrbecker on April 11, 2005, at 8:58:29
http://money.cnn.com/2005/04/11/news/international/sanofi.reut/
New sleeping pill gets delayed
Sanofi-Aventis faces a delay in launching Ambien CR to resolve certain issues with the FDA.
April 11, 2005: 8:42 AM EDT
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PARIS (Reuters) - Sanofi-Aventis SA faces a delay in launching Ambien CR -- a new form of its best-selling sleeping pill -- because U.S. regulators want more information on the product.Shares in the world's third-largest drugmaker fell as much as 1.8 percent Monday after it said it had received an "approvable" letter from the Food and Drug Administration (FDA) for the medicine, rather than full approval.
The move means it must resolve certain issues with the FDA before Ambien CR can be sold in the world's biggest market.
The French company said these issues were not related to the safety or effectiveness of Ambien CR, a new controlled-released version of its established blockbuster medicine Ambien, or Stilnox.
The already marketed version of Ambien faces competition from other sleeping drugs, such as Sepracor Inc's (Research) Lunesta, and is to lose its patent protection in October 2006, or in 2007 if it wins an extension for use by children.
Ambien sales were 1.42 billion ($1.8 billion) last year, up 15 percent compared with 2003.
Shares in Sanofi, which has said it hopes to launch Ambien CR in the United States by mid-2005, were down 1.5 percent at 66.50 by 1010 GMT after hitting a low of 66.30.
Sanofi has said it expects to file Ambien CR for European marketing approval by the middle of this year.
Its shares were also pressured by a downgrade from Credit Suisse First Boston, which cut its recommendation on the stock to "neutral" from "outperform," though with a maintained price target of 66.
The brokerage said the stock had rallied 15 percent so far this year and that the market needed reassurance on several uncertainties -- particularly threats to patents on Plavix and Allegra and questions about anti-obesity drug Acomplia -- to justify a further advance.
CSFB said there was also a risk that the recent strong rise in the share price might tempt block sales by major shareholder Total.
http://www.newratings.com/analyst_news/article_770784.html
Sanofi-Aventis Has Setback With Ambien CR
Monday, April 11, 2005 4:53:20 AM ET
Dow Jones Newswire
0838 GMT [Dow Jones] Sanofi-Aventis (SNY) suffers a setback on Ambien CR as FDA requests more information before allowing it to the market. "It's pretty bad because it delays the launch of this follow up to their blockbuster drug Ambien by at least six months," says Lombard Odier Darier Hentsch analyst. Ambien loses patent protection in '07. Delay leaves company with less time to switch patients over to the new version. Also, there's increasing competition for Ambien, he says. Not rated. Trades -1.3% at EUR66.65. (AAG)
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poster:jrbecker
thread:482705
URL: http://www.dr-bob.org/babble/20050408/msgs/482707.html