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UPDATE 2-Sanofi's Acomplia wins approval from UK health body

Wed Mar 26, 2008 4:34am EDT

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PARIS, March 26 (Reuters) - French drugmaker Sanofi-Aventis (SASY.PA) said on Wednesday that its troubled obesity-fighting product Acomplia had won approval from Britain's National Institute for Health and Clinical Excellence (NICE).

Sanofi, the world's third-biggest drugmaker, said NICE had recommended that Acomplia should be made available for the management of obese and overweight patients on the UK's state-run National Health Service.

The move is a small positive for a medicine that has failed to live up to expectations and had total sales of only 79 million euros ($123 million) last year, analysts said.

The UK decision contrasts with Germany where Acomplia is not reimbursed by health insurers because it is deemed simply to improve lifestyle.

The British government has made fighting obesity, particularly among young people, one of its key priorities.

In January, official British health data showed that obesity drug prescriptions had soared in the country, and health minister Alan Johnson said the UK faced an obesity crisis.

Acomplia was once touted as a multibillion-dollar seller, but hopes for the product dimmed last year when a U.S. expert panel recommended against its approval in the world's biggest market, after it was linked to rare cases of suicidal thoughts.

Sanofi said in October it expected only limited sales of the drug in the next few years, until new clinical trial results were ready for submission to regulators in 2009.

"A recommendation for use of Acomplia in (British) National Health Service patients is a small step forward for a product that so far has been disappointing," analysts at Nomura Code Securities said in a note.

The French group is expanding clinical trials of the medicine as a treatment for type 2 diabetes, which is closely linked with obesity.

Acomplia -- also known by the brand name Zimulti in the United States and generically as rimonabant -- is the first in a new class of drugs that switch off the same brain circuits that make people hungry when they smoke cannabis.

In February, Sanofi posted a 6.2 percent rise in fourth-quarter adjusted net profit and a big increase in its 2007 dividend as tight cost controls offset lower sales.

Sanofi also forecast a 7 percent rise in 2008 adjusted earnings per share.

Sanofi shares were 0.6 percent lower at 47.17 euros in early trade, in line with a weaker European drugs sector. The stock has fallen by around 25 percent since the start of 2008. (Reporting by Sudip Kar-Gupta and Ben Hirschler; Editing by Louise Ireland)



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