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June 13, 2016 9:30 am ET

Data in Patients with Type 1 and Type 2 Diabetes Presented for the First Time at the 76 ^th Scientific Sessions of the American Diabetes Association

Merck (NYSE: MRK), known as MSD outside of the United States and Canada,
today announced results from two Phase 3 studies evaluating MK-1293,
Merck’s investigational, follow-on biologic* insulin glargine candidate
for the treatment of people with type 1 and type 2 diabetes. In both
studies, MK-1293 achieved its primary endpoint by demonstrating
non-inferiority in change from baseline A1C (a measure of average blood
glucose) and similar safety to Lantus^® (insulin glargine)**
after 24 weeks in patients with type 1 and type 2 diabetes. Furthermore,
in both studies, MK-1293 met its pre-specified secondary efficacy
endpoints of statistical A1C equivalence to Lantus, a measure used to
show that an investigational treatment is similar, within an acceptable
range, to a current therapy.

“It is encouraging to see that the investigational agent MK-1293 met its
primary and secondary endpoints,” said Philip Home, D.M., D.Phil,
professor of diabetes medicine, Newcastle University, United Kingdom.
“These data, together with other clinical studies of its time-action
profile, suggest that Merck’s insulin glargine, if approved, could help
provide glycemic control in appropriate patients with type 1 and type 2
diabetes.”

MK-1293 has the same amino acid sequence as Lantus, the originator
insulin glargine. The development of MK-1293 builds on an agreement
between Merck and Samsung Bioepis established in February 2013 to
develop and commercialize multiple biosimilar candidates across
different therapeutic areas. Under the terms of a subsequent 2014
agreement, Merck is responsible for the clinical development,
manufacturing and, if approved, commercialization of MK-1293. Samsung
Bioepis is partially funding its development.

“The investigational agent MK-1293 represents Merck’s entry into insulin
therapeutics and into treatments that may be useful for patients with
type 1 diabetes, and we are pleased with these Phase 3 results,” said
Peter Stein, M.D., vice president, late stage development, diabetes and
endocrinology, Merck. “As a follow-on biologic, MK-1293 has the
potential to offer a treatment option for pediatric and adult patients
with type 1 diabetes and for adults with type 2 diabetes who use basal
insulin to help control their glucose levels.”

MK-1293 in Patients with Type 1 Diabetes (296-OR)

The Phase 3, randomized, active-controlled, open-label trial assessed
the efficacy and safety of MK-1293 (n= 245) compared with Lantus (n=263)
in patients with type 1 diabetes. The primary efficacy endpoint was
non-inferiority of change from baseline A1C at week 24. At baseline,
patients had an A1C level equal to or less than 11.0 percent and were
taking basal and prandial insulin.

The primary endpoint of the study was met, demonstrating the
non-inferiority of MK-1293 to Lantus in patients with type 1 diabetes.
The least-squares mean difference in A1C (MK-1293 minus Lantus) was 0.04
percent (95% CI: -0.11, 0.19), meeting A1C non-inferiority (upper bound
of the confidence interval <0.4%) and equivalence (confidence interval
within -0.4% and 0.4%) criteria. Basal insulin doses were similar
between groups (MK-1293 minus Lantus; difference of -0.7 U/day; 95% CI
-2.5, 1.0 U/day).

The primary safety objective was anti-insulin antibody (AIA)
development. Similar AIA, including incidence and titers, and similar
neutralizing antibody responses were seen between treatment groups. The
study found that 74 percent of patients receiving Lantus and 70 percent
receiving MK-1293, irrespective of AIA status at baseline, had an AIA
positive result at or before week 24. Additionally, 36 percent of
patients receiving Lantus and 33 percent of patients receiving MK-1293
who were negative for AIA at baseline had an AIA positive result at or
before week 24.

No clinically meaningful difference in safety endpoints of interest were
seen between treatment groups. In this study, 76.4 percent of patients
receiving Lantus and 71.0 percent of patients receiving MK-1293
experienced symptomatic hypoglycemia. In addition, 0.4 percent of
patients receiving Lantus and 0.8 percent of patients receiving MK-1293
experienced an injection site reaction; 0.4 percent of patients
receiving MK-1293 and none taking Lantus experienced a systemic allergic
reaction; 1.9 percent of patients receiving Lantus and 0.4 percent of
patients receiving MK-1293 experienced angioedema or a severe cutaneous
adverse reaction. There were no reports of anaphylactic response in
either treatment group.

MK-1293 in Patients with Type 2 Diabetes (926-P)

The Phase 3, randomized, active-controlled, open-label trial assessed
the efficacy and safety of MK-1293 (n=265) compared to Lantus (n=266) in
patients with type 2 diabetes inadequately controlled on diet and
exercise alone. The primary efficacy endpoint was non-inferiority of
change from baseline A1C at week 24. At baseline, patients had an A1C
level equal to or less than 11.0 percent and were eligible for or were
taking basal insulin greater than or equal to 10 U/day.

MK-1293 met the study’s primary endpoint, demonstrating non-inferiority
to Lantus with a least-squares mean difference in A1C (MK-1293 minus
Lantus) of 0.03 percent (95% CI: -0.12, 0.18), meeting A1C
non-inferiority (upper bound of the confidence interval <0.4%) and
equivalence (confidence interval within -0.4% and 0.4%) criteria. Basal
insulin doses were similar between groups (MK-1293 minus Lantus;
difference of 1.4 U/day; 95% CI -2.2, 4.9 U/day).

The primary safety objective was anti-insulin antibody (AIA)
development. Similar AIA, including incidence and titers, and similar
neutralizing antibody responses were seen between treatment groups. In
the study, 29.0 percent of patients receiving Lantus and 34.7 percent
being treated with MK-1293, irrespective of AIA status at baseline, had
an AIA positive at or before week 24. Additionally, 14.9 percent of
patients receiving Lantus and 19.3 percent of patients receiving MK-1293
who were negative of AIA at baseline had an AIA positive at or before
week 24.

No clinically meaningful between-group differences were found for
pre-defined safety endpoints of interest. Symptomatic hypoglycemia was
observed in 52.1 percent of patients receiving Lantus and 53.2 percent
of patients receiving MK-1293. In the study, 0.4 percent of patients
receiving Lantus and 1.9 percent of patients receiving MK-1293
experienced an injection site reaction; 0.4 percent of patients
receiving MK-1293 and none taking Lantus experienced a systemic allergic
reaction; 0.4 percent of patients receiving MK-1293 and none taking
Lantus experienced an anaphylactic response; and 1.1 percent of patients
receiving Lantus and 0.4 percent of patients receiving MK-1293
experienced angioedema or severe cutaneous adverse reaction.

About Merck

For 125 years, Merck has been a global health care leader working to
help the world be well. Merck is known as MSD outside the United States
and Canada. Through our prescription medicines, vaccines, biologic
therapies, and animal health products, we work with customers and
operate in more than 140 countries to deliver innovative health
solutions. We also demonstrate our commitment to increasing access to
health care through far-reaching policies, programs and partnerships.
For more information, visit www.merck.com
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Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the
“company”) includes “forward-looking statements” within the meaning of
the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995. These statements are based upon the current beliefs
and expectations of the company’s management and are subject to
significant risks and uncertainties. There can be no guarantees with
respect to pipeline products that the products will receive the
necessary regulatory approvals or that they will prove to be
commercially successful. If underlying assumptions prove inaccurate or
risks or uncertainties materialize, actual results may differ materially
from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest
rate and currency exchange rate fluctuations; the impact of
pharmaceutical industry regulation and health care legislation in the
United States and internationally; global trends toward health care cost
containment; technological advances, new products and patents attained
by competitors; challenges inherent in new product development,
including obtaining regulatory approval; the company’s ability to
accurately predict future market conditions; manufacturing difficulties
or delays; financial instability of international economies and
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and other protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause results
to differ materially from those described in the forward-looking
statements can be found in the company’s 2015 Annual Report on Form 10-K
and the company’s other filings with the Securities and Exchange
Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

*A follow-on biologic is a similar, but not identical, version of an
approved reference product. In the U.S., MK-1293 is referred to as a
follow-on biologic because of its regulatory pathway. In other
countries, it is considered to be a biosimilar.

**LANTUS is a registered trademark of Sanofi-Aventis, which is not
affiliated with the maker of MK-1293 and does not endorse MK-1293.

Merck
Media:
Doris Li, 908-246-5701
Kristen Drake, 908-334-4688
or
Investor:
Justin Holko, 908-740-1879