) received encouraging news with the European Commission (EC)
approving its diabetes candidate, Lyxumia (lixisenatide). The EC
cleared Lyxumia for glycemic control in patients, above 18 years
of age, suffering from type II diabetes. 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.
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The EC approved Lyxumia on the basis of the GetGoal phase III
program. The GetGoal program, initiated in May 2008, consisted of
11 trials which enrolled more than 5,000 type II diabetes
patients. Lyxumia demonstrated a promising efficacy and
tolerability profile in the trials. Sanofi in-licensed Lyxumia
from Zealand Pharma.
The European approval of Lyxumia did not come as a surprise as
the European Medicines Agency's (EMA) Committee for Medicinal
Products for Human Use (CHMP) had recommended the approval of
Lyxumia for the indication in Nov 2012.
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. The approval of
Lyxumia encouraging 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 last few months, several of Sanofi's
pipeline 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. We note that Sanofi has a
worldwide collaboration with
Regeneron Pharmaceuticals Inc.
) for the development and commercialization of Zaltrap.
Sanofi carries a Zacks Rank #1 (Strong Buy) in the short run.
) are examples of pharma stocks which are also favorably placed.
Both companies carry a Zacks Rank #1 (Strong Buy).