) diabetes segment has been performing well spearheaded by its
lead product Lantus. Lantus sales are on the rise. The diabetes
segment was further boosted by the EU approval of Lyxumia
(lixisenatide) in Feb 2013.
The EC approved Lyxumia in combination with oral
glucose-lowering medicinal products and/or basal insulin when
these, in combination with lifestyle management, did not provide
adequate glycemic control. In the second quarter of 2013, the
drug generated sales of approximately €1 million.
In September, Sanofi announced its decision to withdraw the new
drug application (NDA) for lixisenatide in the U.S. Sanofi was
looking to get the drug approved for type II diabetes. The NDA
included early interim data from the ongoing ELIXA cardiovascular
(CV) outcomes study.
The company believes that potential public disclosure will
hamper the integrity of the ELIXA CV study, which is expected to
complete in the next 15 months. Sanofi intends to resubmit the
NDA for lixisenatide in 2015, following the completion of the
ELIXA CV study.
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A sub-analysis of the GetGoal-L study revealed that Lyxumia in
combination with basal insulin with or without metformin showed
impressive efficacy. These effects were more pronounced in
patients with relatively well-controlled baseline fasting plasma
Sanofi had in-licensed lixisenatide from Zealand Pharma.
Although Sanofi holds a strong position in the diabetes market,
we note that the market is highly crowded with players like
Eli Lilly and Co.
Sanofi carries a Zacks Rank #4 (Sell). We are concerned about
generic erosion confronting most of Sanofi's key drugs.
Additionally pipeline failures (oncology candidate -- iniparib
and anticoagulant -- otamixaban) have put immense pressure on
Not all large-cap pharma companies are performing as badly as
Sanofi. Novo Nordisk is well placed with a Zacks Rank #2