By Elena Berton Of DOW JONES NEWSWIRES LONDON -(Dow Jones)- Sanofi-Aventis SA (SNY) Thursday said its experimental heart drug Multaq will be reviewed by a panel of Food and Drug Administration experts in March, which suggest the U.S. regulator may be cautious about the French drugmaker's key pipeline product.
The drug, known generically as dronedarone, was granted priority review in early August, with a decision by the FDA expected around January.
"This is a further delay to the product and in our view reflects the agency's uncertainty around the drug's profile," said Deutsche Bank analysts, who have a hold recommendation on the stock.
Multaq, a potential multi-billion dollar product if it gets approved, was submitted to regulators in the U.S. and Europe in June.
The convocation of an advisory meeting is not unexpected and reflects the fact the FDA is now more risk averse, but doesn't mean the product is dead, said Collins Stewart analyst James Knight, who has a buy recommendation on the stock.
At 0930 GMT, Sanofi-Aventis shares were trading up 2.1%, or EUR0.90, at EUR43.08 in a higher Paris market. The stock is down 31% year-on-year, though.
Sanofi-Aventis is testing Multaq as a treatment of a heart condition called atrial fibrillation, a type of irregular heartbeat that can cause blood clots and stroke.
The drug has become one of the bright spots in Sanofi-Aventis' pipeline, after overcoming some setbacks.
In 2003, the French drugmaker halted one trial of the drug when it appeared patients taking Multaq were dying at a higher rate than those taking a dummy treatment, although two other studies didn't show any serious side effects.
Three years later, the FDA rejected Multaq saying it needed more information. But earlier this year, it assigned priority review to Multaq after Sanofi-Aventis filed a new marketing application.
A priority review, given to drugs that address unmet medical needs, means the FDA will take six months to review the product for approval, compared with ten months for a standard review.
Company Web site: www.sanofi-aventis.com
-By Elena Berton, Dow Jones Newswires; 44 20 7842 9267; elena.berton@dowjones.com
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(END) Dow Jones Newswires
November 27, 2008 04:56 ET (09:56 GMT)

Publié le 27 novembre 2008 Copyright © 2008 Dowjones