Data in Patients with Type 1 and Type 2
Diabetes Presented for the First Time at the 76th
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 and connect with us on Twitter, Facebook, YouTube and
LinkedIn.
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 sovereign risk;
dependence on the effectiveness of the company’s patents 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.
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MerckMedia:Doris Li, 908-246-5701Kristen Drake,
908-334-4688orInvestor:Justin Holko, 908-740-1879
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