) received some encouraging news with the European Medicines
Agency's (EMA) Committee for Medicinal Products for Human Use
(CHMP) recommending the approval of its candidate, Lemtrada. The
company is looking to get Lemtrada approved for the treatment of
relapsing remitting multiple sclerosis (RRMS). Sanofi expects a
final decision on Lemtrada by the European Commission (EC) in the
next few months.
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The CHMP issued a positive opinion on Lemtrada based on 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
as compared to
) Rebif resulted in a 55% reduction in the relapse rate over the
two-year span of the study.
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
We remind investors that Lemtrada is also under review for the
above mentioned indication in the US. The US Food and Drug
Administration is expected to render a decision on Lemtrada's
marketing application towards the end of this year.
Apart from issuing a positive opinion on Lemtrada, CHMP also
recommended a new active substance (NAS) designation for another
RRMS drug, Aubagio.
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, a large-cap pharma company, carries a Zacks Rank #3
(Hold). However, other large cap pharma stocks such as
) currently look more attractive with a Zacks Rank #2 (Buy).