Merck Submits New Drug Application to the Japanese Pharmaceuticals & Medical Devices Agency for Omarigliptin, an Investigatio...
November 24 2014 - 8:00AM
Business Wire
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 diabetes.
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, visit www.merck.com and connect
with us on Twitter, Facebook 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 (www.sec.gov).
___________________________1 IDF Diabetes Atlas. 6th Edition.
Available at
http://www.idf.org/sites/default/files/DA6_Regional_factsheets_0.pdf
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
http://www.easd.org/images/easdwebfiles/annualmeeting/50thmeeting/Prog-at-Glance.html.
Last accessed September 2014.
MerckMedia:Pam Eisele267-305-3558orKim Hamilton908-740-1863 /
908-391-0131orInvestors:Justin Holko908-423-5088
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