Merck Receives Breakthrough Therapy Designation from FDA & PRIME Status from EMA for Investigational Ebola Zaire Vaccine (V920)
July 25 2016 - 8:00AM
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 Annuziato,
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, Facebook, 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 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).
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MerckMedia:Pamela Eisele, 267-305-3558Skip Irvine,
215-652-6059orInvestors:Teri Loxam, 908-740-1986Justin Holko,
908-423-5088
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