) subsidiary, Genzyme, recently announced that the US Food and Drug
Administration (FDA) has issued a refuse-to-file letter in relation
to its marketing application for Lemtrada (alemtuzumab). In June
2012, the company had submitted a supplemental Biologics License
Application (sBLA) to the FDA for Lemtrada for the treatment of
relapsing multiple sclerosis (RMS).
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The FDA has not asked for any additional studies but Sanofi will
have to rework on the presentation of the data. Sanofi plans to
work along 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 and is
under regulatory review.
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. Key players in the multiple sclerosis market include
) among others.
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
We currently have a Neutral recommendation on Sanofi. The stock
carries a Zacks #3 Rank (Hold rating) in the short run.