Eli Lilly and Company
) and Boehringer Ingelheim recently announced that the European
Medicines Agency (EMA) has accepted their marketing authorisation
application (MAA) for LY2963016.
The companies are looking to get LY2963016 approved for type I
and II diabetes under the EMA's biosimilar pathway. LY2963016 is
a new insulin glargine product.
LY2963016 has been developed under a collaboration agreement
between Eli Lilly and Boehringer Ingelheim which was signed in
Jan 2011. The companies had signed a global agreement for the
joint development and commercialization of several diabetes
The compounds covered by the agreement include Tradjenta
(linagliptin) which is currently approved in the US, Japan,
Europe and other countries, empagliflozin and the new insulin
glargine product. Boehringer Ingelheim also has an option to
co-develop and co-commercialize Eli Lilly's anti-TGF-beta
We note that Eli Lilly and Boehringer Ingelheim had submitted
a New Drug Application (NDA) for empagliflozin in the US earlier
this year. Empagliflozin is also under regulatory review in the
Eli Lilly currently holds a Zacks Rank #3 (Hold). The biggest
near-term challenge for Eli Lilly will be to replace the revenues
that will be lost to generic competition now that Zyprexa has
lost US and EU exclusivity. The generic threat will continue to
pose challenges for Eli Lilly with Cymbalta slated to lose patent
protection in late 2013 and Evista in 2014.
On the flip side, the Animal Health business and the diabetes
franchise should provide some downside support. We are encouraged
by the company's efforts to strengthen its diabetes portfolio. We
are also pleased to see Eli Lilly pursuing small acquisitions and
in-licensing deals to boost its pipeline.
Companies that currently look attractive include
). While Santarus and Jazz are Zacks Rank #1 (Strong Buy) stocks,
Auxilium is a Zacks Rank #2 (Buy) stock.
AUXILIUM PHARMA (AUXL): Free Stock Analysis
JAZZ PHARMACEUT (JAZZ): Free Stock Analysis
LILLY ELI & CO (LLY): Free Stock Analysis
SANTARUS INC (SNTS): Free Stock Analysis
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