) recently announced that the European Medicines Agency's (EMA)
Committee for Medicinal Products for Human Use (CHMP) recommended
the approval of its diabetes candidate, Lyxumia (lixisenatide).
Sanofi is looking to get Lyxumia approved for glycemic control in
patients with type II diabetes, who are above 18 years, in
combination with oral glucose-lowering medicinal products and/or
basal insulin when these, together with lifestyle management, do
not provide adequate glycemic control.
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The European Commission (EC) is expected to take a final decision
on Lyxumia in the next 2 to 3 months. The company plans to file
for US approval in December 2012.
The CHMP rendered a positive opinion on Lyxumia on the basis of
the GetGoal phase III program. The GetGoal program was initiated
in May 2008 and consisted of 11 trials, which enrolled more than
5,000 type II diabetes patients in total. The candidate
demonstrated a promising efficacy and tolerability profile in the
trials. Sanofi in-licensed Lyxumia from Zealand Pharma.
The diabetes market, while crowded, represents significant
commercial potential. Key players in the diabetes market include
) among others.
We are pleased with Sanofi's progress with its pipeline. Over the
last few months, several of Sanofi's pipeline candidates gained
approval including US approval of Aubagio (teriflunomide) for
relapsing forms of multiple sclerosis (RMS) and US approval of
Zaltrap (aflibercept) as a combination therapy for
treatment-experienced patients suffering from metastatic
colorectal cancer. Recently, the CHMP also recommended the
approval of Zaltrap for the aforementioned indication. We note
that Sanofi has a worldwide collaboration with
Regeneron Pharmaceuticals Inc.
) for the development and commercialization of Zaltrap.
We expect Sanofi to continue to contain operating costs in order
to increase earnings in the face of weakening sales of some of
its biggest products. We also expect the company to pursue