) and its subsidiary Genzyme recently announced that their oral
candidate for relapsing forms of multiple sclerosis (RMS), Aubagio
(teriflunomide), has received US Food and Drug Administration (FDA)
approval. The FDA approved Aubagio as a once-daily treatment for
patients with RMS. Aubagio is currently under regulatory review in
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FDA approval came in on encouraging data from a pivotal phase III
study (TEMSO) in patients with RMS. The TEMSO phase III study
evaluated Aubagio in two dosage strengths, 7mg and 14mg. Patients
in both 7mg and 14mg Aubagio dosage arms demonstrated a 31%
reduction in annualized relapse rate compared to placebo.
Additionally, the company presented positive results from the phase
III TOWER trial, which was conducted on 1,169 patients with RMS.
However, we note that in the TENERE trial, reported in December
2011, Aubagio failed to show statistical superiority over
) Rebif. There are two more studies in progress, namely TOPIC and
Competition in the oral multiple sclerosis market will be intense
and Aubagio needs to demonstrate superior efficacy and tolerability
to gain share.
) Gilenya already has a lead in the oral MS market with the product
being approved in September 2010. Another major competitor could be
) BG-12, which is currently under regulatory review in the US and
Another RMS candidate, Lemtrada (alemtuzumab), in Sanofi's
portfolio, suffered a setback last month when the FDA issued a
refuse-to-file letter in relation to its marketing application.
Though the FDA has not asked for any additional studies, Sanofi
will have to rework on the presentation of the data. Sanofi plans
to work with the FDA and resubmit the marketing application as
early as possible.
A marketing application for Lemtrada for RMS was also filed with
the European Medicines Agency (EMA), which has been accepted for
We currently have a Neutral recommendation on Sanofi. The stock
carries a Zacks #3 Rank (Hold rating) in the short run.