) recently provided an update on its pipeline. Sanofi boasts of a
robust pipeline with 65 new molecular entities and vaccines in
clinical development, of which 17 are in phase III development or
under regulatory review.
We note that several of Sanofi's candidates will be up for
approval in the coming quarters. The French pharma giant expects
regulatory decision in the EU on Zaltrap (aflibercept) for
second-line metastatic colorectal cancer and Lyxumia
(lixisenatide) for type II diabetes in the first quarter of 2013.
The US Food and Drug Administration (FDA) is also expected to
render a final decision regarding acceptance of Lyxumia's new
drug application (NDA) in the first quarter of 2013.
Sanofi expects the FDA to give a final decision on its
candidate, Kynamro (mipomersen) for treating patients suffering
from homozygous familial hypercholesterolemia, by January 29,
The company expects an opinion from the Committee for
Medicinal Products for Human Use (CHMP) on Aubagio
(teriflunomide) for treating patients suffering from relapsing
multiple sclerosis (MS) in the first quarter of 2013. The CHMP is
expected to issue its opinion regarding the EU approval of
another MS candidate in Sanofi's pipeline, Lemtrada
(alemtuzumab), in the second quarter of 2013.
Turning to the vaccine pipeline, the FDA is expected to decide
on the intramuscular quadrivalent formulation of Fluzone in the
second quarter of 2013. Moreover, the CHMP is expected to render
its opinion on pediatric hexavalent vaccine in the first quarter
Another vaccine for the prevention of primary symptomatic
difficile infections (CDI) is expected to move into phase III
studies in the third quarter of 2013.
Sanofi also expects data from several phase III studies during
the course of the year.
Overall, 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
We currently have a Neutral recommendation on Sanofi. The
stock carries a Zacks Rank #2 (Buy) in the short run.
Pharma stocks which currently look more attractive are
). Both these companies carry a Zacks Rank #1 (Strong Buy).
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