MARIZEV® (Omarigliptin), Merck’s Once-Weekly DPP-4 Inhibitor for Type 2 Diabetes, Approved in Japan

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September 28, 2015 6:30 am ET

Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that the Japanese Pharmaceuticals and Medical Devices
Agency (PMDA) has approved MARIZEV® (omarigliptin) 25 mg and
12.5 mg tablets, an oral, once-weekly DPP-4 inhibitor indicated for the
treatment of adults with type 2 diabetes. Japan is the first country to
have approved omarigliptin.

“More than 6 million adults in Japan have type 2 diabetes1
and many still struggle to control their blood sugar levels,” said Tony
Alvarez, president, MSD in Japan. “The approval of MARIZEV in Japan
demonstrates our long-term commitment to diabetes and leadership in the
DPP-4 inhibitor class. We believe MARIZEV offers an important option for
people in Japan to manage their type 2 diabetes, particularly for those
who prefer once-weekly dosing.”

The approval of MARIZEV in Japan is based on Phase 3 trials of Japanese
patients. The worldwide clinical development program for omarigliptin,
O-QWEST (Omarigliptin Q Weekly Efficacy and Safety
in Type 2 Diabetes), includes 10 Phase 3 clinical trials
involving approximately 8,000 patients with type 2 diabetes. Merck plans
to submit omarigliptin for regulatory approval in the United States by
the end of 2015. Other worldwide regulatory submissions will follow. The
trademark for omarigliptin in other countries has not yet been announced.

Merck commitment to diabetes

At Merck, we are committed to improving type 2 diabetes care through
scientific advancement and innovation for the millions of people living
with diabetes every day. We strive to deliver a broad range of
treatments and educational tools for patients and healthcare providers
and are applying significant resources and capabilities with a continued
focus on research and development.

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.

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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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 2014 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).

References

1 IDF Diabetes Atlas. 6th Edition. Available at: https://www.idf.org/membership/wp/japan

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