Eli Lilly and Company
) recently announced top-line data on its type II diabetes
candidate, dulaglutide. The company said that dulaglutide met its
primary endpoint in two phase III studies (AWARD-2 and AWARD-4)
which are a part of the AWARD program.
Dulaglutide is a glucagon-like peptide 1 (GLP-1) analog which
is being developed for the once-weekly treatment of type II
Eli Lilly said that with dulaglutide (1.5 mg) meeting the
primary efficacy endpoint of non-inferiority to insulin glargine,
superiority for lowering HbA1c levels was also evaluated.
Dulaglutide 1.5 mg achieved a statistically superior reduction in
HbA1c level compared to insulin glargine at 52 weeks in type II
diabetes patients on metformin and glimeperide (AWARD-2).
Moreover, results from AWARD-4 showed that dulaglutide 1.5 mg
plus insulin lispro demonstrated a statistically superior
reduction in HbA1c levels compared to insulin glargine plus
insulin lispro at 26 weeks.
Gastrointestinal events were the most frequently reported
adverse events. This has been observed in other GLP-1 agonists as
We note that positive top-line results from the other three
AWARD studies were presented in Oct 2012. Results from the AWARD
program will be used to support dulaglutide regulatory filings,
which are scheduled for this year.
While we are encouraged with the phase III data, we note that
the GLP-1 market is getting pretty crowded. While approved
) Victoza and
) Bydureon and Byetta, other big pharma companies also have GLP-1
candidates in late-stage development.
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
) currently looks attractive with a Zacks Rank #1 (Strong
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