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.ALLERGAN INC (AGN): Free Stock Analysis ReportBIOGEN IDEC INC (BIIB): Free Stock Analysis
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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
Aubagio generated US sales of €7 million in the fourth quarter of
2012. We believe that Aubagio represents significant
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).