) recently announced that the US Food and Drug Administration
(FDA) has accepted the marketing application of its type II
diabetes candidate, lixisenatide. The company is looking to get
lixisenatide approved for the treatment of adults with type II
The company submitted the New Drug Application for
lixisenatide on the basis of the GetGoal program. The program
initiated in May 2008, consisted of 11 trials and enrolled more
than 5,000 type II diabetes patients. Lixisenatide demonstrated a
promising efficacy and tolerability profile in the trials. Sanofi
had in-licensed lixisenatide from Zealand Pharma.
We remind investors that the European Commission (EC) cleared
lixisenatide (brand name: Lyxumia in EU) for glycemic control in
adults suffering from type II diabetes on Feb 1, 2013. The drug
is expected to be launched by the end of the first quarter of
The EC approved Lyxumia in combination with oral
glucose-lowering medicinal products and/or basal insulin when
these, together with lifestyle management, fail to provide
adequate glycemic control.
We note that Sanofi is looking to combat the generic threat
confronting most of its key drugs by signing deals, making
acquisitions and introducing new products. If lixisenatide is
cleared in the US then it will boost Sanofi's top-line
significantly since as the type II diabetes market offers
significant commercial potential.
We believe that the pipeline at Sanofi must deliver to combat
the generic threat. We are pleased with Sanofi's efforts to
develop its pipeline. Over the past few months, several of
Sanofi's candidates gained approval including the US approval of
Aubagio (teriflunomide) for relapsing forms of multiple sclerosis
(RMS) and the US and EU approval of Zaltrap (aflibercept) as a
combination therapy for treatment-experienced patients suffering
from metastatic colorectal cancer.
Sanofi carries a Zacks Rank #3 (Hold) in the short run. Pharma
companies that currently look better-positioned include
Eli Lilly and Company
). All three companies carry a Zacks Rank #2 (Buy).
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