Authorization Represents Significant
Advancement in the Global Response to Ebola
Merck Remains Committed to Working with
International Health Partners in Ebola Outbreak Response
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced that the European Commission has granted a
conditional marketing authorization to ERVEBO for active
immunization of individuals 18 years of age or older to protect
against Ebola Virus Disease (EVD) caused by Zaire Ebola virus. The
use of ERVEBO should be in accordance with official
recommendations. The approval is based on data submitted to the
European Medicines Agency for accelerated assessment in March 2019.
With this approval, the European Commission will grant a
centralized marketing authorization with unified labeling that is
valid in the 28 countries that are members of the European Union,
as well as European Economic Area members, Iceland, Liechtenstein
and Norway. ERVEBO is currently under Priority Review with the U.S.
Food and Drug Administration (FDA) with a target action date of
March 14, 2020.
“The European Commission’s marketing authorization of ERVEBO is
the result of an unprecedented collaboration for which the entire
world should be proud. It is a historic milestone and a testament
to the power of science, innovation and public-private
partnership,” said Kenneth C. Frazier, chairman and chief executive
officer, Merck. “After recognizing the need and urgency for an
Ebola Zaire vaccine, many came together across sectors to answer
the global call for outbreak preparedness. We at Merck are honored
to play a part in Ebola outbreak response efforts and we remain
committed to our partners and the people we serve. We also look
forward to continuing to work with the FDA and the African
countries on their regulatory reviews over the coming months and
with the World Health Organization on vaccine prequalification,
which will help broaden access to this important vaccine for those
who need it most.”
Given the unique manufacturing requirements for ERVEBO, this
approval allows Merck to initiate manufacturing of licensed doses
in Germany, which are expected to start becoming available in the
third quarter of 2020. Merck is also working closely with the World
Health Organization (WHO), the United States Government, and Gavi,
the Vaccine Alliance, to ensure uninterrupted access of its
investigational Ebola Zaire vaccine (V920) in support of ongoing
international response efforts in the DRC. As previously announced,
Merck has committed to manufacture additional doses of
investigational V920 over the coming year.
As part of its clinical development, and in response to requests
from the WHO, Merck has, to date, donated more than 250,000 1.0mL
doses of V920 to the WHO for use in outbreak response efforts
occurring in the DRC since May 2018.
Merck has made a submission to the WHO seeking prequalification
status for the vaccine, as well as submissions to selected African
country National Regulatory Authorities in collaboration with the
African Vaccine Regulatory Forum (AVAREF), which, if approved, will
allow the vaccine to be registered in several African
countries.
More About the Development of Investigational V920 V920
was initially engineered by scientists from the Public Health
Agency of Canada’s National Microbiology Laboratory and the
technology was subsequently obtained by a subsidiary of NewLink
Genetics Corporation. In late 2014, when the Ebola outbreak in
western Africa was at its peak, and with the goal of applying its
capabilities in process research, clinical development, and
manufacturing to an important global effort, Merck acquired the
rights to develop 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 vaccine supply replenishment activities
are supported by partial Federal funding from BARDA under Contract
No. HHSO100201700012C. Merck has been 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 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/20191111005601/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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