) subsidiary, Genzyme, recently announced that the US Food and
Drug Administration (FDA) has accepted the marketing application
of Lemtrada (alemtuzumab). The company is looking to get Lemtrada
approved for the treatment of relapsing multiple sclerosis (RMS).
FDA's decision regarding the approval of Lemtrada is expected in
the second half of 2013.
We remind investors that in Aug 2012, the FDA issued a
refuse-to-file letter in relation to Lemtrada's marketing
application. Lemtrada is also under review for the same
indication in the EU. The Committee for Medicinal Products for
Human Use (CHMP) is expected to render an opinion on the approval
of Lemtrada in the second quarter of 2013.
Lemtrada's marketing application includes data from 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
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 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.
We are pleased with Sanofi's efforts to develop its pipeline,
which should make significant revenue contributions upon
approval. However, we note that Sanofi's biggest challenge is the
generic threat that is faced by several of its products.
Sanofi carries a Zacks Rank #2 (Buy) in the short run.
) is an example of a pharma stock which is more favorably placed.
The company carries a Zacks Rank #1 (Strong Buy).
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