Sanofi’s Aubagio Wins Clearance of U.K. Drug-Cost Agency

Sanofi’s multiple sclerosis pill Aubagio was cleared by the U.K.’s health-cost regulator, less than three months after the overseer said it didn’t have enough information for approval, as the company agreed to a price cut.

Aubagio is recommended for treating adults with the relapsing-remitting form of multiple sclerosis, the most common type of the illness, after Sanofi made it available at a discount under the patient-access scheme, the National Institute for Care Excellence said in final draft guidance today.

Sanofi won European Union approval for the tablet in August and U.S. backing in September 2012. The company has been building up an MS-treatment business since its 2011 purchase of Genzyme Corp. gave it access to Lemtrada, another experimental drug for the nerve-damaging illness. Paris-based Sanofi needs new products to offset revenue losses from generic competition to best-sellers including the blood thinner Plavix.

The French company has estimated the average annual cost of Aubagio at 13,529 pounds ($22,100) per patient, NICE said. The agency, which makes recommendations to the U.K.’s state-owned National Health Service on whether treatments offer value for money, didn’t disclose the size of the discount that Sanofi agreed to provide.

Stock Declines

Sanofi fell as much as 0.3 percent and was down 0.1 percent at 74.08 euros as of 1:29 p.m. in Paris. The stock has returned 7.4 percent this year, including reinvested dividends, compared with a 25 percent advance in the Bloomberg Europe Pharmaceuticals Index.

Aubagio may generate annual sales of 651 million euros ($890 million) by 2018, according to the average of eight analyst estimates compiled by Bloomberg.

Multiple sclerosis is a debilitating disease that attacks the central nervous system. Relapses, or flare-ups, are episodes of worsening neurological function. More than 100,000 people in the U.K. have the disease, according to the Multiple Sclerosis Trust.

NICE asked Sanofi yesterday for more information on Lemtrada before recommending that drug, without saying what data it requested.

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