Merck Continues to Expand Investigational
Supply to Support International Ebola Outbreak Response
Merck, known as MSD outside the United States and Canada, today
announced that the U.S. Food and Drug Administration (FDA) has
accepted the Biologics License Application (BLA) and granted
priority review for Merck’s investigational Ebola vaccine (V920),
under review for the prevention of disease caused by the Ebola
Zaire virus. The Prescription Drug User Fee Act (PDUFA), or target
action date, is set for March 14, 2020. In July 2016, the FDA
granted Breakthrough Therapy Designation to V920.
“Merck has worked with government partners and the global health
community to accelerate development of our investigational V920
Ebola vaccine. FDA’s priority review designation underscores our
long-standing partnership with the U.S. government toward its
development and licensure,” said Dr. Paula Annunziato, vice
president, Merck Research Laboratories. “A top priority for us
remains achieving registration of V920 and regulatory approval of
our German manufacturing site, so that licensed supply can be
produced over time to support global public health preparedness and
health security objectives. We look forward to continuing to work
with the FDA throughout the review process.”
In parallel to its regulatory efforts, Merck has remained
steadfast in its commitment to scale-up the number of
investigational V920 Ebola vaccine doses being produced to help
international public health officials and government authorities
meet ongoing, unpredictable, and evolving outbreak response needs
in the Democratic Republic of the Congo (DRC) and neighboring
countries. Since May 2018, Merck has donated and shipped more than
245,000 1.0mL investigational V920 Ebola vaccine doses to the World
Health Organization (WHO) in response to requests by the WHO.
Beyond doses already delivered, more than 190,000 additional 1.0mL
investigational doses are currently available and ready to ship to
the outbreak region at WHO's request.
In addition, in June 2019, Merck started executing an updated
replenishment strategy to increase investigational V920 Ebola
vaccine supply, based on ongoing consultations with the U.S.
Department of Health and Human Services, WHO and Gavi (the Vaccine
Alliance). The strategy targets production of an additional
estimated 650,000 1.0mL investigational doses, to be released and
made available in a phased manner over the next 6-to-18 months. In
total, past, current and upcoming production will amount to more
than 900,000 1.0mL investigational doses of V920. Stockpiles are
inherently dynamic, and therefore all estimates included here are
as of the time of this statement and subject to change.
New investigational supply will be based on a combination of
leveraging material from ongoing production activities at the
planned commercial manufacturing site in Germany and new production
at a clinical manufacturing site in the U.S. While the company
continues to explore opportunities to accelerate production, our
timing estimates are based on the need to meet manufacturing and
quality-control requirements.
“We continue to be proud and humbled to provide our
investigational V920 Ebola vaccine as an additional tool in support
of the comprehensive public health response efforts against the
current Ebola outbreak. Merck appreciates and continues to work
closely with our collaborators and is inspired by the relentless
determination of everyone involved, especially frontline
responders, working to contain this unique and dangerous outbreak,”
Dr. Annunziato added.
Status of International Regulatory Filings for Merck’s
Investigational V920 Ebola Zaire Vaccine
In March 2019, the European Medicines Agency (EMA) accepted the
Marketing Authorization Application (MAA) for V920 for review. In
parallel, and in close collaboration with FDA and EMA, submissions
have also been made to the WHO to achieve prequalification status
and to health authority representatives of the African Vaccine
Regulatory Forum (AVAREF).
About Merck’s Investigational V920 Ebola Zaire
Vaccine
V920, Merck’s investigational Ebola Zaire vaccine, 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) and the
Department of Defense’s Defense Threat Reduction Program (DTRA) and
Joint Vaccination Acquisition Program (JVAP), among others. Merck’s
V920 investigational supply replenishment activities are supported
by partial Federal funding from BARDA under Contract No.
HHSO100201700012C. 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 100 years, Merck has contributed to the discovery
and development of novel medicines and vaccines to combat
infectious diseases. In addition to a combined portfolio of
vaccines and antibacterial, antiviral and antifungal medicines,
Merck has multiple programs that span discovery through late-stage
development. To learn more about Merck’s infectious diseases
pipeline, visit www.merck.com.
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,
visit www.merck.com and connect with us on Twitter, Facebook,
Instagram, 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 2018
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).
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version on businesswire.com: https://www.businesswire.com/news/home/20190917005341/en/
Media: Pamela Eisele 267-305-3558
Skip Irvine 267-305-0338
Investors: Peter Dannenbaum 908-740-1037
Michael DeCarbo 908-740-1807
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