Eli Lilly and Company
) recently provided encouraging data on its diabetes candidate,
dulaglutide. Dulaglutide is a long-acting glucagon-like peptide 1
(GLP-1) receptor agonist being developed as a once-weekly
treatment for type II diabetes.
The company presented detailed safety and efficacy data from
three phase III AWARD trials. Dulaglutide 1.5 mg was found to be
superior to placebo and
) Byetta (exenatide), metformin and
) Januvia (sitagliptin) in AWARD-1, AWARD-3, and AWARD-5,
respectively, in the reduction of HbA1c levels.
Moreover, a higher percentage of patients in the dulaglutide
arm achieved an HbA1c goal of less than 7% versus all active
comparators. Patients in the dulaglutide arm also showed
sustained weight loss during the course of the trials. While
weight loss was significant compared to Januvia in AWARD-5, it
was similar to Byetta and metformin in AWARD-1 and AWARD-3,
Hypoglycemia rates were also low in the dulaglutide arms. All
these data were presented at the American Diabetes Association
Eli Lilly had presented positive top-line data on dulaglutide
from the AWARD-2 and AWARD-4 studies earlier this year.
Results from the AWARD program will be used to support
dulaglutide regulatory filings, which are scheduled for this
Although we are encouraged with the data on dulaglutide, we
note that the GLP-1 market is getting pretty crowded. While
approved products include
) Victoza and Bristol-Myers' Bydureon and Byetta, other big
pharma companies also have GLP-1 candidates in late-stage
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 also
pleased to see Eli Lilly pursuing small acquisitions and
in-licensing deals to boost its pipeline.
Novo Nordisk currently looks attractive with a Zacks Rank #2
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