) subsidiary, Genzyme, recently announced that it has filed
marketing applications for Lemtrada (alemtuzumab) for the treatment
of relapsing multiple sclerosis (RMS) in both the EU and the US.
The company has submitted a supplemental Biologics License
Application (sBLA) to the US Food and Drug Administration (FDA) and
a marketing authorization application (MAA) to the European
Medicines Agency (EMA).
Lemtrada demonstrated efficacy and safety in two phase III
trials, which were completed in 2011. In the first study, CARE-MS
I, Lemtrada met the first primary endpoint. Results showed that
treatment with two annual cycles of Lemtrada resulted in a 55%
reduction in relapse rate compared to
) Rebif over the two-year span of the study. However, Lemtrada
failed to achieve statistical significance for the second primary
endpoint. Results showed that 8% of patients treated with Lemtrada
had a sustained increase in their Expanded Disability Status Scale
(EDSS) score (or worsening) compared to 11% of the patients on
In the second study, CARE-MS II, Lemtrada met both the primary
endpoints. Results showed that treatment with Lemtrada resulted in
a 49% reduction in relapse rate compared to Rebif, over a two-year
period. Additionally, Lemtrada showed a 42% reduction in the risk
of sustained accumulation (worsening) of disability.
Lemtrada is being developed in collaboration with
Sanofi's pipeline also includes Aubagio (teriflunomide), another
RMS drug. Aubagio is under regulatory review in both the US and the
EU. Earlier this month, the company reported positive top-line
results from a last-stage trial of Aubagio.
We are pleased with the company's efforts to develop its
pipeline. We expect Sanofi to continue to contain operating costs
in order to increase earnings in the face of weakening sales of
some of its biggest products. We also expect the company to pursue
bolt on acquisitions.
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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