Reuters: Regulatory News: UPDATE 2-Positive test boosts Sanofi MS drug hopes

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UPDATE 2-Positive test boosts Sanofi MS drug hopes Jun 1st 2012, 09:52 Fri Jun 1, 2012 5:52am EDT * Daily dose of Aubagio reduces rate of relapse * Sanofi seeks to catch up with rival Novartis * Shares down 1.2 pct in line with CAC 40 By Christian Plumb and Elena Berton PARIS, June 1 (Reuters) - Sanofi reported positive results from a late-stage trial of its Aubagio multiple sclerosis drug, bolstering its chances of approval by regulators as it seeks to catch up with a fast-selling oral treatment from rival Novartis. Sanofi said it found that a daily dose of the treatment, one of two multiple sclerosis drugs it has in late-stage development, reduced the rate of relapse by 36 percent compared with a placebo. The study assessed the efficiency and safety of Aubagio in 1,169 patients with relapsing forms of multiple sclerosis. The full data from the study will be presented at an upcoming scientific meeting, Sanofi said. Cheuvreux analyst Marcel Brand, who has an "outperform" recommendation on Sanofi stock, said the results were positive and consistent with earlier data, "which is reassuring". Brand expects Aubagio to generate peak sales of $1.8 billion in 2018, taking around 11 percent of volume market share. The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) are both reviewing marketing applications for Aubagio as a treatment for relapsing forms of MS. The FDA's response is due by July 2012, while EMA is expected to give its feedback in the first quarter of 2013. Compared with older therapies, Aubagio has the advantage of being an oral drug. But it has produced less impressive results in clinical tests than other oral MS treatments and has failed to show it was better than a commonly used injectable drug for MS, although it did have milder side effects. Analysts expect the drug could find a niche among newly diagnosed patients, since around 35 to 40 percent of MS patients prefer to take no medication rather than face unwanted side effects. MS pills Gilenya by Novartis and Biogen Idec Inc's BG-12 are seen dominating a market that JPMorgan analysts predict growing to $14 billion in 2015 from $9.6 billion last year. MS, which has no cure, affects 2.5 million people worldwide. It is a chronic, often disabling disease that attacks the central nervous system and can lead to numbness, paralysis and loss of vision. Sanofi shares, which have declined around 3.5 percent since the start of the year, were trading 1.2 percent lower at 54.34 euros at 0935 GMT, matching a fall in the CAC 40 index. Link this Share this Digg this Email Reprints

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