) subsidiary, Genzyme, recently announced encouraging top-line
results on its phase III candidate, Aubagio (teriflunomide).
Results were presented from the phase III TOWER trial, which was
conducted on 1,169 patients with relapsing forms of multiple
sclerosis (RMS). Full results from the trial are being analyzed and
will be presented at an upcoming scientific meeting.
The TOWER pivotal phase III trial evaluated Aubagio in two
dosage strengths, 7mg and 14mg. Patients in the 14mg dosage Aubagio
arm demonstrated a 36.3% reduction in annualized relapse rate
compared to placebo. The reduction was statistically significant.
Additionally, a 31.5% reduction in the risk of 12-week sustained
accumulation of disability was also observed.
Meanwhile, patients in the 7mg dosage Aubagio arm demonstrated a
22.3% reduction in annualized relapse rate compared to placebo.
However, the reduction in the risk of 12-week sustained
accumulation of disability was not statistically significant.
TOWER is the third completed study evaluating the efficacy of
Aubagio in RMS patients. In October 2010, Sanofi had announced
positive results on Aubagio from a pivotal phase III study (TEMSO)
in patients with RMS. However, Aubagio failed to show statistical
) Rebif in the TENERE trial, reported in December 2011. There are
two more studies in progress, namely TOPIC and TERACLES, which
makes the program one of the largest and broadest amongst any oral
multiple sclerosis programs under development.
Sanofi filed for US approval of Aubagio in August 2011 and EU
approval in February 2012.
Competition in the oral multiple sclerosis (MS) 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 both the US
and the EU.
We currently have a Neutral recommendation on Sanofi. The stock
carries a Zacks #3 Rank (Hold rating) in the short run.
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