Lilly’s Once-Weekly Dulaglutide Shows Non-Inferiority to Liraglutide in Head-to-Head Phase III Trial for Type 2 Diabetes

INDIANAPOLIS, Feb. 27, 2014 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY)
today announced positive top-line results of the sixth AWARD (Assessment of
Weekly AdministRation of LY2189265 in Diabetes) trial for once-weekly
dulaglutide, an investigational, long-acting glucagon-like peptide 1 (GLP-1)
receptor agonist being studied as a treatment for type 2 diabetes.

In the AWARD-6 study, once-weekly dulaglutide 1.5 mg achieved the primary
endpoint of non-inferiority to once-daily liraglutide 1.8 mg, as measured by the
reduction of hemoglobin A1c (HbA1c) from baseline at 26 weeks.

“Dulaglutide is the only GLP-1 agonist to show non-inferiority against
liraglutide’s highest-approved dose in a Phase III trial,” said Enrique
Conterno, president of Lilly Diabetes. “The AWARD-6 data, along with the
previous five AWARD studies, give us confidence that dulaglutide can be an
important treatment option for people with type 2 diabetes. If approved,
dulaglutide would be the only GLP-1 agonist that is both once-weekly and
ready-to-use.”

Adverse events were similar for patients in both treatment groups. The most
frequently reported events were gastrointestinal-related. These findings are
consistent with prior studies of once-weekly dulaglutide.

Once-weekly dulaglutide has been submitted to the U.S. Food and Drug
Administration (FDA), the European Medicines Agency (EMA) and other regulatory
bodies. All previous five AWARD trials (1-5) included demonstrated superiority
in reduction of HbA1c at the 1.5 mg dose against placebo and active comparators.

Lilly plans to present detailed data from the AWARD-6 (dulaglutide vs.
liraglutide), AWARD-2 (dulaglutide vs. insulin glargine), and AWARD-4
(dulaglutide vs. insulin glargine; both in combination with insulin lispro)
studies at scientific meetings later this year.

About the AWARD (Assessment of Weekly AdministRation of LY2189265 in Diabetes)
studies

AWARD-1 was a randomized, 52-week, placebo-controlled comparison of the effects
of once-weekly dulaglutide and exenatide on glycemic control in patients with
type 2 diabetes on metformin and pioglitazone. The primary objective of the
study, conducted in 978 patients, was to evaluate whether dulaglutide 1.5 mg,
dosed once-weekly, was superior to placebo in reducing HbA1c from baseline at 26
weeks.

AWARD-2 was a randomized, 78-week, open-label comparison of the effects of
once-weekly dulaglutide and insulin glargine on glycemic control in patients
with type 2 diabetes on metformin and glimepiride. The primary objective of the
study, conducted in 807 patients, was to evaluate whether dulaglutide 1.5 mg,
dosed once-weekly, was non-inferior to insulin glargine in reducing HbA1c from
baseline at 52 weeks. Superiority testing was performed since the statistical
criterion for non-inferiority was satisfied.

AWARD-3 was a randomized, 52-week, double-blind comparison of the effects of
once-weekly dulaglutide and metformin on glycemic control in patients with early
type 2 diabetes. The primary objective of the study, conducted in 807 patients,
was to evaluate whether dulaglutide 1.5 mg, dosed once-weekly, was non-inferior
to metformin in reducing HbA1c from baseline at 26 weeks. Superiority testing
was performed since the statistical criterion for non-inferiority was satisfied.

AWARD-4 was a randomized, 52-week, open-label comparison of the effects of
once-weekly dulaglutide and insulin glargine, both in combination with insulin
lispro, in patients with type 2 diabetes. The primary objective of the study,
conducted in 884 patients, was to evaluate whether dulaglutide 1.5 mg, dosed
once-weekly, in combination with insulin lispro, was non-inferior to insulin
glargine in combination with insulin lispro, in reducing HbA1c from baseline at
26 weeks. Superiority testing was performed since the statistical criterion for
non-inferiority was satisfied.

AWARD-5 was a randomized, 104-week, double-blind, placebo-controlled comparison
of the effects of once-weekly dulaglutide and sitagliptin on glycemic control in
patients with type 2 diabetes on metformin. The primary objective of the study,
conducted in 1,098 patients, was to evaluate whether dulaglutide 1.5 mg, dosed
once-weekly, was non-inferior to sitagliptin in reducing HbA1c from baseline at
52 weeks. Superiority testing was performed since the statistical criterion for
non-inferiority was satisfied.

AWARD-6 was a randomized, open-label, parallel-arm study comparing the effects
of once-weekly dulaglutide and once-daily liraglutide on glycemic control in
patients with type 2 diabetes on concomitant metformin. The primary objective of
the study, conducted in 599 patients, was to evaluate whether dulaglutide 1.5
mg, dosed once-weekly, was non-inferior to liraglutide 1.8 mg, dosed once-daily,
in reducing HbA1c from baseline at 26 weeks.

About Diabetes
Approximately 25.8 million Americans1 and an estimated 382 million people2
worldwide have type 1 and type 2 diabetes. Type 2 diabetes is the most common
type, accounting for an estimated 90 to 95 percent of all diabetes cases.
Diabetes is a chronic disease that occurs when the body either does not properly
produce, or use, the hormone insulin.2

About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced
the world’s first commercial insulin. Today we are building upon this heritage
by working to meet the diverse needs of people with diabetes and those who care
for them. Through research and collaboration, a broad and growing product
portfolio and a continued determination to provide real solutions–from
medicines to support programs and more–we strive to make life better for all
those affected by diabetes around the world. For more information, visit
www.lillydiabetes.com.

About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make
life better for people around the world. We were founded more than a century ago
by a man committed to creating high-quality medicines that meet real needs, and
today we remain true to that mission in all our work. Across the globe, Lilly
employees work to discover and bring life-changing medicines to those who need
them, improve the understanding and management of disease, and give back to
communities through philanthropy and volunteerism. To learn more about Lilly,
please visit us at www.lilly.com and http://newsroom.lilly.com/social-channels.

P-LLY

This press release contains forward-looking statements about dulaglutide that
are based on Lilly’s current expectations. Actual results could differ
materially from these expectations. There are significant risks and
uncertainties in the process of drug development and commercialization. There
can be no guarantee that future study results and patient experience will be
consistent with the study findings to date. There can also be no guarantee that
dulaglutide will be approved by regulatory authorities or that it will prove to
be commercially successful. For further discussion of these and other risks and
uncertainties that could cause actual results to differ from Lilly’s
expectations, please see the company’s latest Forms 10-K and 10-Q filed with the
U.S. Securities and Exchange Commission. Except as required by law, the company
undertakes no duty to update forward-looking statements.

(1) Centers for Disease Control. National Diabetes Fact Sheet-2011. Available at: http://www.cdc.gov/diabetes/pubs/
pdf/ndfs_2011.pdf. Accessed on: February 22, 2012.

(2) International Diabetes Federation. Diabetes Atlas, 6th Edition: Fact Sheet. 2013.

Refer to: Candace Johnson, +1-317-755-9143, johnson_candace_a@lilly.com

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SOURCE Eli Lilly and Company

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