obesity drug Acomplia endorsed by EU panel
(Adds Deutsche Bank sees higher sales potential)
By Ben Hirschler
LONDON, April 28 (Reuters) - A panel of European experts has backed the use of Sanofi-Aventis's <SASY.PA> anti-obesity pill Acomplia, the French drugmaker's biggest new drug hope.
The London-based European Medicines Agency said on Friday its experts had recommended Acomplia as an adjunct to diet and exercise for obese or overweight patients with associated risk factors, such as Type 2 diabetes or dyslipidaemia.
Industry analysts said the fact the committee of medical experts had highlighted the link with serious risk factors was good news and would help Sanofi position Acomplia as more than a simple weight-loss medicine.
Sanofi argues that Acomplia -- which switches off the same brain circuits that make people hungry when they smoke cannabis
-- can prevent the risk of cardiovascular disease.
Recommendations for marketing approval by the Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.
Sanofi said once final marketing approval had been delivered, Acomplia would be made available on prescription across the European Union.
"The first launches should come in the second half of 2006," the company said in a statement.
Sanofi has said in the past that the drug could eventually generate annual sales of more than $3 billion, but industry analysts say its exact potential will depend on the label it carries and the willingness of governments and insurers to pay for it.
SHARES RALLY
Shares in Sanofi were 2.5 percent higher at 75.40 euros by 1110 GMT following the news, outperforming a 0.8 percent gain in the European drugs sector <.SXDP>.
"This is good news, especially as the associated risk factors are specified by the experts," said Natexis Bleichroeder analyst Florent Cespedes.
Analysts at Dresdner Kleinwort Wasserstein said the decision to recommend Acomplia for obese patients with other risk factors suggested the label would include data on its ability to improve cholesterol and other factors, and was better than expected.
U.S. health authorities issued a so-called "approvable" letter for Acomplia in February, asking Sanofi for more information before granting marketing clearance.
Sanofi hopes to launch the medicine in the United States in the second half as well. A company spokesman said on Friday that discussions with the Food and Drug Administration (FDA) were continuing.
Deutsche Bank analysts currently forecast Acomplia revenue will be 1.2 billion euros ($1.5 billion) in 2010, below others, but said there could be 1 billion upside if the FDA took a similar stance to the CHMP in approving Acomplia as a weight loss agent but with weight independent benefits on diabetes and cholesterol.
The CHMP also backed a number of other drugs for marketing approval, including Tysabri, a multiple sclerosis treatment from Elan Corp <ELN.I> and Biogen Idec <BIIB.O>. Elan shares jumped more than 5 percent.
It also backed Bayer's <BAYG.DE> kidney cancer drug Nexavar and recommended the early use of Roche's <ROG.VX> breast cancer treatment Herceptin. Pfizer Inc's <PFE.N> cancer drug Sutent was recommended for conditional approval.
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