Sanofi’s (SNY) subsidiary Genzyme recently announced that its oral candidate for relapsing forms of multiple sclerosis (:RMS), Aubagio (teriflunomide) 14 mg, has gained approval from Argentina’s National Administration of Drugs, Food and Medical Technology (:ANMAT). The ANMAT approved Aubagio as a once-daily treatment for patients with RMS.
The Argentinean approval came on the basis of data from a pivotal phase III study (:TEMSO) in patients with RMS. In the trial, Aubagio demonstrated promising efficacy and safety profile.
We note that Argentina is the third country where Aubagio received approval. Aubagio received approval in the US (Sep 2012) and Australia (Nov 2012) as a once-daily treatment for patients with RMS. Aubagio is under review in many other countries.
In Mar 2013, the European Medicines Agency's (:EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Aubagio. However, 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 generated US sales of €7 million in the fourth quarter of 2012. We believe that Aubagio represents 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 apart from Aubagio, FDA approved oral multiple sclerosis therapies include Novartis’ (NVS) Gilenya and Biogen Idec’s (BIIB) Tecfidera (dimethyl fumarate, formerly BG-12).
Sanofi carries a Zacks Rank #4 (Sell) in the short run. Right now, Novartis and Allergan Inc. (AGN) look more attractive in the pharma space with a Zacks Rank #2 (Buy).
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