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CHMP in Favor of Sanofi's Aubagio

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Recently, Sanofi (SNY - Free Report) received some encouraging news with the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending the approval of its drug, Aubagio (teriflunomide). The company is looking to get Aubagio approved for the treatment of relapsing forms of multiple sclerosis (RMS) in adult patients.

We note that CHMP did not recommend a new active substance (NAS) designation for Aubagio. Sanofi is planning to request a re-examination of CHMP’s decision in relation to the NAS designation.

Aubagio is already approved in the US (Sep 2012) as an oral once-daily treatment for patients with RMS and generated US sales of €7 million in the fourth quarter of 2012. We believe that Aubagio possesses significant commercialization opportunity.

Sanofi has another RMS candidate, Lemtrada (alemtuzumab), in its pipeline. The FDA’s decision regarding the approval of Lemtrada is expected in the second half of 2013.

We note that competition in the oral multiple sclerosis market is intense. Novartis’ (NVS - Free Report) Gilenya already has a lead in the oral MS market with the product being approved in Sep 2010. Another major competitor could be Biogen Idec’s (BIIB - Free Report) Tecfidera (dimethyl fumarate, formerly BG-12) which is currently under regulatory review in the US and EU. A response from the US Food and Drug Administration (FDA) on the approval of Tecfidera is expected shortly.  

Sanofi carries a Zacks Rank #3 (Hold) in the short run, while Merrimack carries a Zacks Rank #4 (Sell). Right now, Novo Nordisk (NVO - Free Report) looks more attractive in the pharma space with a Zacks Rank #2 (Buy).

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