Eli Lilly and Company
) and partner Boehringer Ingelheim Pharmaceuticals, Inc.
announced that the new drug application (NDA) for their
empagliflozin−Tradjenta (linagliptin) combination has been
accepted for review by the U.S. Food and Drug Administration
(FDA). The companies are looking to get the combination approved
for the treatment of adults suffering from type II diabetes.
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We note that empagliflozin is also under review for type II
diabetes in the U.S. and the EU. Recently, empagliflozin received
a positive opinion from the Committee for Medicinal Products for
Human Use (CHMP) for this indication. Eli Lilly and its partner
intend to launch it in 2014, if approved. Eli Lilly has another
candidate, dulaglutide, under review in the U.S. and the EU for
Eli Lilly is working on strengthening its diabetes franchise.
However, the market is highly crowded given the presence of
) among others.
Meanwhile, Eli Lilly is facing a major challenge in the form of
loss of exclusivity for Zyprexa and Cymbalta. However, the Animal
Health business and the diabetes franchise should provide some
We are also pleased to see Eli Lilly pursuing small acquisitions
and in-licensing deals to boost its pipeline.
We expect 2014 to be a catalyst rich year for Eli Lilly with the
expected filing of a number of regulatory applications and a few
Eli Lilly carries a Zacks Rank #3 (Hold). A better-ranked stock
in the pharma sector is
Questcor Pharmaceuticals, Inc.
), carrying a Zacks Rank #1 (Strong Buy).