) subsidiary, Genzyme, recently announced interim data on its
multiple sclerosis (MS) candidate, Lemtrada (alemtuzumab), from
the first year of an extension study. Lemtrada is currently
under regulatory review in both the US and the EU for the
treatment of MS. Sanofi expects a final decision on Lemtrada by
both the European Medicines Agency (EMA) and the US Food and Drug
Administration (FDA) by the end of this year.
The extension study enrolled patients from two pivotal 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 the 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
patients on Rebif.
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 the relapse rate compared to Rebif, over a
two-year period. Additionally, Lemtrada showed a 42%
reduction in the risk of sustained accumulation (worsening) of
The extension study enrolled more than 90% of the MS patients who
received Lemtrada in the phase III pivotal studies. The interim
results from the first year of the extension study demonstrated
that 67% of the patients from CARE-MS I study and 55% patients
from CARE-MS II study were relapse-free in the first year.
We are pleased with Sanofi's efforts to develop its pipeline,
which should fetch significant revenue contributions upon
approval. We believe that the pipeline at Sanofi must deliver,
since many of its drugs are facing generic competition.
Sanofi carries a Zacks Rank #3 (Hold) in the short run. However,
other large cap pharma stocks such as
) currently look more attractive with a Zacks Rank #2 (Buy).
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