Merck Receives Breakthrough Therapy Designation from FDA and PRIME Status from EMA for Investigational Ebola Zaire Vaccine (V920)

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July 25, 2016 7:00 am ET

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced two regulatory milestones for the company’s
investigational vaccine for Ebola Zaire, V920 (rVSV∆G-ZEBOV-GP, live
attenuated): the U.S. Food and Drug Administration (FDA) has granted the
vaccine candidate Breakthrough Therapy Designation, and the European
Medicines Agency (EMA) has granted PRIME (PRIority MEdicines)
status.

The FDA’s Breakthrough Therapy Designation is intended to expedite the
development and review of a candidate that is planned for use, alone or
in combination, to treat a serious or life-threatening disease or
condition when preliminary clinical evidence indicates that the drug may
demonstrate substantial improvement over existing therapies on one or
more clinically significant endpoints.

PRIME is an approach from the European Medicines Agency (EMA) to enhance
support for the development of medicines that target an unmet medical
need. PRIME is intended to optimize development plans and speed up
assessment of the medicine’s application so these medicines may
potentially reach patients earlier. PRIME focuses on medicines that may
offer a major therapeutic advantage over existing treatments, or benefit
patients without treatment options. These medicines are considered
priority medicines by EMA. To be accepted for PRIME, a medicine has to
show its potential to benefit patients with unmet medical needs based on
early clinical data.

“The granting of Breakthrough Therapy Designation by the FDA and PRIME
status by the EMA will enable us to continue to accelerate development
of V920, and we greatly appreciate the collaboration of these agencies
in moving this vaccine candidate forward in potentially meeting this
public health need,” said Paula Annunziato, M.D., vice president for
clinical research, Merck Research Laboratories.

V920 was initially engineered by scientists from the Public Health
Agency of Canada’s National Microbiology Laboratory and subsequently
licensed to a subsidiary of NewLink Genetics Corporation. In late 2014,
when the peak of the Ebola outbreak in western Africa was at its worst,
Merck licensed V920 from NewLink Genetics, with the goal of accelerating
the development, licensure, and availability of this candidate vaccine.
Since that time, Merck has worked closely with NewLink Genetics and a
number of external collaborators to enable a broad clinical development
program with funding from the U.S. Government including the Department
of Health and Human Service’s Biomedical Advanced Research Development
Authority (BARDA) and the Department of Defense’s Defense Threat
Reduction Program/Joint Vaccination Acquisition Program (DTRA/JVAP)
among others. Additional research evaluating V920 is ongoing.

Merck is responsible for the research, development, manufacturing, and
regulatory efforts in support of V920. The company has committed to
working closely with other stakeholders to accelerate the continued
development, production and, if licensed, distribution of the vaccine.

Merck’s Commitment to infectious diseases

For more than 80 years, Merck has contributed to the discovery and
development of novel medicines and vaccines to combat infectious
disease. In addition to a combined portfolio of antibiotic and
antifungal medicines, vaccines, and medicines for HIV and HCV. Merck has
multiple programs that span discovery through late-state development.
Merck currently has 10 compounds in Phase 2/Phase 3 clinical trials for
the potential treatment or prevention of infectious diseases.

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,
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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
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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).



Merck
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Pamela Eisele, 267-305-3558
Skip Irvine, 215-652-6059
or
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Teri Loxam, 908-740-1986
Justin Holko, 908-423-5088

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