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


August 5, 2016 7:00 am ET

Marketing Authorization Application to the European Medicines Agency Currently Under Review

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

“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
and connect with us on Twitter,
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 (

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.

Doris Li, 908-246-5701
Kristen Drake, 908-236-4223
Amy Klug, 908-740-1898

Unsubscribe from email alerts