Merck Submits New Drug Application to the Japanese Pharmaceuticals and Medical Devices Agency for Omarigliptin, an Investigational Once-Weekly DPP-4 Inhibitor for Type 2 Diabetes


November 24, 2014 8:00 am ET

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that the company has submitted a new drug application
for omarigliptin, its investigational once-weekly DPP-4 inhibitor for
the treatment of type 2 diabetes, to the Japanese Pharmaceuticals and
Medical Devices Agency (PMDA).

“Merck is committed to helping patients with type 2 diabetes and we are
excited about the submission of the new drug application for
omarigliptin in Japan,” said Peter Stein, M.D., vice president, clinical
research, diabetes and endocrinology, Merck Research Laboratories. “More
than six million adults in Japan have type 2 diabetes1 . If
approved in Japan, omarigliptin could provide an important new treatment
option to help these patients attain their blood sugar goals.”

The new drug application for omarigliptin is based on a comprehensive
clinical development program in Japan. The results from the first Phase
3 study of omarigliptin, conducted in Japan, were presented recently at
the 50th European Association for the Study of Diabetes
(EASD) Annual Meeting2.

Japan is the first country with a regulatory filing for omarigliptin.
Worldwide, Merck is supporting omarigliptin with a clinical development
program that includes nine Phase 3 clinical trials involving
approximately 7,500 patients with type 2 diabetes in support of planned
regulatory filings.

Merck’s Commitment to Diabetes

Through our research initiatives, on our own and in collaboration with
others, Merck is committed to strengthening its leadership in diabetes
to deliver a broad portfolio of products to help patients with type 2

About Merck

Today’s Merck is a global healthcare 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 healthcare through
far-reaching policies, programs and partnerships. For more information,
and connect with us on Twitter,
and YouTube.

Merck Forward-Looking Statement

This news release includes “forward-looking statements” within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. These statements are based
upon the current beliefs and expectations of Merck’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; Merck’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 Merck’s patents and other protections
for innovative products; and the exposure to litigation, including
patent litigation, and/or regulatory actions.

Merck 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 Merck’s 2013 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 (

1 IDF Diabetes Atlas. 6th
Edition. Available at

2 Gantz, I et al. Effect of a novel once weekly DPP-4
inhibitor, omarigliptin in patients with type 2 diabetes: a
double-blind, placebo- and sitagliptin-controlled, non-inferiority
trial. Presentation 115, presented at 50th EASD Annual Meeting on
September 17 2014. Available at
Last accessed September 2014.

Pam Eisele
Kim Hamilton
908-740-1863 / 908-391-0131
Justin Holko

Unsubscribe from email alerts