PARIS, Nov 27 (Reuters) - Sanofi-Aventis' experimental heart drug Multaq will be reviewed by an independent expert panel in the United States next March, marking a delay in a priority review by the health regulator.
The world's No.3 drugmaker said on Thursday the advisory panel on Multaq, which some analysts forecast could yield more than $2 billion in annual sales, would meet on March 18.
Multaq won a priority review from the U.S. Food and Drug Administration at the end of July. At the time, some analysts said this suggested a likely decision by the U.S. healthcare regulator by the end of January 2009 or in the first quarter of 2009.
The FDA grants priority review to new drugs that could present a safe and effective therapy where no satisfactory alternative exists. Priority reviews generally take 6 months.
"It clearly is a delay, but given that it has increasingly become common practice by the FDA to delay reviews whether standard or priority it is not a surprise," ABN AMRO analyst Michael Leacock said.
He referred to the time the FDA took to give its marketing approval to GlaxoSmithKline's blood drug Promacta. In May an advisory panel backed the drug, which won priority review in March, but Promacta only got the final go-ahead last week.
Danish pharmaceuticals group Novo Nordisk said in September an FDA assessment of its type 2 diabetes drug Liraglutide is likely to be delayed by some two months from March 2009.
"We don't read anything material in it and we don't change our forecasts," Leacock added, rating Sanofi shares "buy" with a price target of 54. He forecast peak sales of Multaq of 720 million euros in 2012.
On Thursday, Sanofi-Aventis shares were about 1.2 percent up at 42.7 euros, following a 20 percent drop this year. They underperformed the CAC-40 French blue-chip index, up 2 percent, but rose more than the 0.97 percent advance of the Dow Jones Stoxx pharmaceuticals index.
A new analysis earlier this month of a previously reported study showed that Multaq significantly reduced the incidence of hospitalisation and length of hospital stays in patients with atrial fibrillation.
Atrial fibrillation is an abnormal heart rhythm in which the upper chambers of the heart beat in an uncoordinated manner, which can cause palpitations, shortness of breath and fatigue.
Sanofi needs Multaq to be a success after several development pipeline setbacks and looming competition to its two top sellers, anticoagulant Lovenox and blood-thinner Plavix.
(Reporting by Caroline Jacobs; Editing by Chris Wickham and Jon Loades-Carter) Keywords: SANOFI/MULTAQ
(paris.equities@news.reuters.com; Reuters Messaging: caroline.jacobs.reuters.com@reuters.net; +33 1 49 49 53 43)
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