From Merck:

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

Monday, September 28, 2015 7:30 am EDT

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KENILWORTH, N.J.--(BUSINESS WIRE)--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 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 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