) announced that its type II diabetes drug, Lyxumia has been
cleared by Japan's Ministry of Health, Labour and Welfare (MHLW).
Lyxumia received approval in Japan as a combination therapy for
glycemic control in type II diabetes patients. These patients did
not receive adequate benefit from diet and exercise and
sulfonylureas (with and without biguanides) or diet and exercise
and soluble prolonged-acting or intermediate-acting insulin (with
and without sulfonylureas).
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The Japanese approval came in 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
We remind investors that the European Commission (EC) cleared
Lyxumia 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 glycemic control. The drug is under review in
the US for the treatment of adults with type II diabetes.
Approval of Lyxumia in Japan would not only boost the drug's
sales potential but also strengthen 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 #3 (Hold). We remain concerned about
generic erosion confronting most of Sanofi's key drugs including
Plavix, Avapro, Lovenox, Taxotere, Eloxatin and Xatral. The
genericization of Avapro and Plavix is expected to negatively
impact Sanofi's business net income by around €800 million in the
first half of 2013.
Sanofi is looking to combat headwinds by containing operating
costs. Additionally, new product launches should make significant
revenue contributions in the upcoming quarters.
Companies that currently look attractive include Novo Nordisk,
carrying a Zacks Rank #2 (Buy).