Eli Lilly and Company
) recently presented positive phase II data on its type II diabetes
candidate, dulaglutide. The company said that dulaglutide met its
primary endpoint in the study. Dulaglutide is a glucagon-like
peptide 1 (GLP-1) analog which is being developed for the
once-weekly treatment of type II diabetes.
Results from the phase II, randomized, double-blind,
placebo-controlled, 26-week, parallel study showed that dulaglutide
achieved non-inferiority after 16 weeks for mean 24-hour systolic
blood pressure (SBP). Two doses (0.75 mg and 1.5 mg) of dulaglutide
were evaluated in comparison to placebo.
With the primary endpoint of non-inferiority being achieved,
superiority testing was conducted. Eli Lilly said that the 1.5 mg
dose achieved a statistically significant reduction in mean 24-hour
SBP compared to placebo. Results at week 26 were similar.
Meanwhile, the non-inferiority criterion for secondary endpoints
like the effect on mean 24-hour diastolic blood pressure (DBP) was
met by both dosages at weeks 16 and 26.
As far as the mean 24-hour heart rate was concerned, the 0.75 mg
dulaglutide dose met the non-inferiority criterion at both weeks 16
and 26 compared to placebo. However, the 1.5 mg dose failed to
achieve the same.
Dulaglutide (both doses) achieved statistically significant
reductions in HbA1c levels compared to placebo at weeks 16 and
Gastrointestinal events were the most frequently reported
adverse events. This has been observed in other GLP-1 agonists as
well. These data were presented at the annual meeting of the
American Society of Hypertension (ASH).
Dulaglutide is currently in phase III studies (AWARD). In
addition to the phase III AWARD studies, dulaglutide will be
evaluated in a cardiovascular outcomes trial (REWIND). Results from
the AWARD trials should be out in 2012 and Eli Lilly could be in a
position to seek approval in 2013.
While we are encouraged with the phase II data, we note that the
GLP-1 market is getting pretty crowded. While approved products
) Victoza and
) Bydureon and Byetta, companies like
) have GLP-1 candidates in late-stage development.
Neutral on Eli Lilly
We currently have a Neutral recommendation on Eli Lilly, which
carries a Zacks #3 Rank (short-term Hold rating). 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
exclusivity in the US and EU.
Zyprexa sales are expected to erode significantly in 2012. The
generic threat will continue to pose challenges for Eli Lilly with
Cymbalta slated to lose patent protection in 2013 and Evista in
We expect the top-and bottom-line to remain under pressure as
the contraction in Zyprexa sales more than offsets growth in
Cymbalta, diabetes and new product sales. On the flip side, the
Animal Health business, Japan and emerging markets should offer
some downside support. We are also pleased to see Eli Lilly
pursuing small acquisitions and in-licensing deals to boost its
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