From Merck:

Merck Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for MK-1293, an Investigational Follow-On Biologic Insulin Glargine

Marketing Authorization Application to the European Medicines Agency Currently Under Review

Friday, August 5, 2016 8:00 am EDT

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KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for MK-1293, an investigational follow-on biologic1 insulin glargine candidate for the treatment of people with type 1 and type 2 diabetes, which is being developed by Merck with partial funding from Samsung Bioepis.

“The FDA acceptance of our follow-on biologic application is an important milestone, and brings us closer to offering another treatment option for people in the U.S. with diabetes,” said Peter Stein, M.D., vice president, late stage development, diabetes and endocrinology, Merck. “We are proud of the significant contributions we have already made to helping people with type 2 diabetes, and with investigational MK-1293, we hope to expand our portfolio into insulin therapeutics and treatments for people with type 1 diabetes.”

The development program for MK-1293 was designed to meet rigorous regulatory standards for follow-on biologics of clinical and nonclinical safety, efficacy and quality. In addition to Phase 1 studies assessing its pharmacokinetic and pharmacodynamic properties, the NDA submission for MK-1293 includes results of two Phase 3 studies , one conducted in people with type 1 diabetes, and one in people with type 2 diabetes; Lantus® (insulin glargine)2, the originator insulin glargine, was the active comparator in both studies.

The NDA was filed through the 505(b)(2) regulatory pathway3, which allows the FDA to reference previous findings of safety and efficacy for an already-approved product (Lantus), in addition to reviewing findings from studies of MK-1293. Separately, the Marketing Authorization Application for MK-1293, which Merck submitted to the European Medicines Agency in December 2015, is currently under review.

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).

1 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, MK-1293 is considered to be a biosimilar.

2 LANTUS is a registered trademark of Sanofi-Aventis, which is not affiliated with the maker of MK-1293 and does not endorse MK-1293.

3 In the U.S., follow-on insulins, such as MK-1293, are reviewed under a different regulatory pathway than biosimilars, which follow the 351(k) regulatory pathway.