Merck Begins Rolling Submission of Licensure Application for V920 (rVSV∆G-ZEBOV-GP) to U.S. Food and Drug Administration


November 13, 2018 4:35 pm ET

V920 is the Company’s Investigational Vaccine for Ebola Zaire

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada,
today announced that it has started the submission of a rolling
Biologics License Application (BLA) to the U.S. Food and Drug
Administration (FDA) for V920 (rVSV∆G-ZEBOV-GP, live attenuated), the
company’s investigational vaccine for Ebola Zaire disease. This rolling
submission is made pursuant to the FDA’s Breakthrough Therapy
Designation for V920, which was announced by the company in July 2016.

“By the FDA agreeing to accept our BLA on a rolling basis, we have
together made another important step forward in accelerating the
regulatory review process for V920,” said Paula Annunziato, M.D., vice
president for clinical research, Merck Research Laboratories. “We are
fully committed to the development of this important vaccine against
Ebola. In the meantime, pre-licensure, investigational doses of V920 are
available to support response to Ebola Zaire outbreaks on an emergency
basis in coordination with global public health authorities.”

Currently, Merck expects the rolling submission of the BLA to be
completed in 2019.

More About Breakthrough Therapy Designation

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.

More About V920

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 Ebola outbreak in western Africa was at its peak, Merck
licensed V920 from NewLink Genetics. Since that time, the company has
worked closely with a number of external collaborators to enable a broad
clinical development program with partial funding from the U.S.
Government, including the Department of Health and Human Service’s
Biomedical Advanced Research Development Authority (BARDA) under
Contract No. HHSO100201700012C and other contracts, as well as the
Department of Defense’s Defense Threat Reduction Program (DTRA) and
Joint Vaccination Acquisition Program (JVAP), among others. 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 more than a century, Merck, a leading global biopharmaceutical
company known as MSD outside of the United States and Canada, has been
inventing for life, bringing forward medicines and vaccines for many of
the world’s most challenging diseases. 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. Today, Merck continues to be at the forefront of
research to advance the prevention and treatment of diseases that
threaten people and communities around the world – including cancer,
cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease
and infectious diseases including HIV and Ebola. For more information,
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Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J.,

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 2017 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 (

Media Contacts:
Pamela Eisele, (267) 305-3558
Skip Irvine, (267) 305-0338
Investor Contacts:
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Mike DeCarbo, (908) 740-1807

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