) recently announced its decision to withdraw the new drug
application (NDA) for lixisenatide in the U.S. Sanofi is looking
to get the drug approved for the treatment of adults with type II
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 be complete in the next 15
months. Sanofi intends to resubmit the NDA for lixisenatide in
2015, post completion of the ELIXA CV study.
The U.S. Food and Drug Administration (FDA) had accepted the
lixisenatide NDA in February this year. Sanofi in-licensed
lixisenatide from Zealand Pharma.
We remind investors that the European Commission (EC) cleared
lixisenatide (trade name: Lyxumia in EU) for glycemic control in
adults suffering from type II diabetes 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
We are disappointed with the withdrawal of the NDA as approval of
lixisenatide in the U.S. would not only have boosted the drug's
sales potential but also strengthened Sanofi's diabetes portfolio
further, which already includes blockbuster product, Lantus.
Although Sanofi holds a strong position in the diabetes market,
we note that the market is highly crowded with players like
Eli Lilly and Company
Sanofi carries a Zacks Rank #5 (Strong Sell). We are concerned
about generic erosion confronting most of Sanofi's key drugs.
Additionally, recent pipeline failures (oncology candidate -
iniparib and anticoagulant - otamixaban) have put immense
pressure on Sanofi's pipeline.
Not all large-cap pharma companies are performing as badly as
Sanofi. Novo Nordisk is well placed with a Zacks Rank #2
ASTRAZENECA PLC (AZN): Free Stock Analysis
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