Phase III Trial of the Merck and NewLink Genetics Investigational Ebola Vaccine Initiated in Sierra Leone
April 14 2015 - 1:30PM
Business Wire
rVSV-ZEBOV-GP (V920) Now Being Studied in
Three Key Safety and Efficacy Clinical Trials
Merck (NYSE:MRK), known as MSD outside the United States and
Canada, and NewLink Genetics Corporation (NASDAQ: NLNK), confirmed
today that the third, late-stage, clinical trial of their Ebola
vaccine candidate rVSV-ZEBOV-GP (V920) has been initiated in Sierra
Leone. The vaccine candidate was originally developed by the Public
Health Agency of Canada’s National Microbiology Laboratory and
licensed to NewLink Genetics in 2010. On Nov. 24, 2014, Merck and
NewLink Genetics announced an exclusive licensing and collaboration
agreement for the investigational Ebola vaccine.
The Phase II/ III safety and effectiveness study, called STRIVE
(Sierra Leone Trial to Introduce a
Vaccine against Ebola) taking place in Sierra Leone
will involve 6,000 health and other frontline workers and is being
led by the Sierra Leone College of Medicine and Allied Health
Sciences, Sierra Leone Ministry of Health and Sanitation, and the
U.S. Centers for Disease Control and Prevention (CDC).
“Fighting Ebola remains a global health priority, and Merck is
committed to advancing the development of our and NewLink’s vaccine
candidate as part of our overall response to the crisis,” said Mark
Feinberg, M.D., Ph.D., chief public health and science officer,
Merck Vaccines.
The Merck and NewLink rVSV-ZEBOV-GP vaccine candidate is now
included in three large-scale clinical trials currently underway in
West Africa. In addition to the trial in Sierra Leone, these trials
are:
- The Partnership for Research on
Ebola Vaccines in Liberia (PREVAIL): Led by a Liberia-U.S.
clinical research partnership and sponsored by the National
Institute of Allergy and Infectious Diseases (NIAID), PREVAIL was
designed to enroll approximately 27,000 healthy men and women aged
18 years and older. This randomized, controlled Phase II/III study
to evaluate safety and efficacy, involves rVSV-ZEBOV-GP and another
experimental Ebola vaccine. Based on declining Ebola virus
incidence in Liberia, the trial leaders have determined that it is
scientifically appropriate to expand the trial to additional sites
in other West African countries. Discussions are underway to
explore that possibility, but the trial has not yet expanded
outside of Liberia.
- Phase III study in Guinea: The
World Health Organization (WHO), the Health Ministry of Guinea,
Médecins sans Frontières (MSF), Epicentre and The Norwegian
Institute of Public Health have initiated a safety and
effectiveness study investigating Merck’s and NewLink’s
rVSV-ZEBOV-GP, the vaccine candidate that was selected by the WHO
and study partners to be assessed first in this study.
About Merck
Today's Merck is a global healthcare 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 healthcare through far-reaching policies, programs and
partnerships. For more information, visit www.merck.com and connect
with us on Twitter, Facebook and YouTube.
About NewLink Genetics Corporation
NewLink is a biopharmaceutical company focused on discovering,
developing and commercializing novel immuno-oncology products to
improve treatment options for patients with cancer. NewLink's
portfolio includes biologic and small molecule immunotherapy
product candidates intended to treat a wide range of oncology
indications. NewLink's product candidates are designed to harness
multiple components of the immune system to combat cancer without
significant incremental toxicity, either as a monotherapy or in
combination with other treatment regimens. BioProtection Systems, a
wholly-owned subsidiary of NewLink Genetics Corporation, is focused
on the research, development and commercialization of vaccines. BPS
is focused on control of emerging infectious diseases, including
improvement of existing vaccines and providing rapid-response
prophylactic and therapeutic treatment for pathogens most likely to
enter the human population through pandemics or acts of
bioterrorism. For more information please visit
http://www.linkp.com.
Merck Forward-Looking Statement
This news release includes “forward-looking statements” within
the meaning of the safe harbor provisions of the United States
Private Securities Litigation Reform Act of 1995. These statements
are based upon the current beliefs and expectations of Merck’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 healthcare
legislation in the United States and internationally; global trends
toward healthcare cost containment; technological advances, new
products and patents attained by competitors; challenges inherent
in new product development, including obtaining regulatory
approval; Merck’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 Merck’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
Merck 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 Merck’s 2014 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).
NewLink Genetics Corporation Forward-Looking
Statement
This press release contains forward-looking statements of
NewLink that involve substantial risks and uncertainties. All
statements, other than statements of historical facts, contained in
this press release are forward-looking statements, within the
meaning of The Private Securities Litigation Reform Act of 1995.
The words "anticipate," "believe," "estimate," "expect," "intend,"
"may," "plan," "target," "potential," "will," "could," "should,"
"seek," or the negative of these terms or other similar expressions
are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words.
These forward-looking statements include, among others, statements
regarding plans to develop and commercialize our product candidates
and any other statements other than statements of historical fact.
Actual results or events could differ materially from the plans,
intentions and expectations disclosed in the forward-looking
statements that NewLink makes due to a number of important factors,
including those risks discussed in "Risk Factors" and elsewhere in
NewLink's Annual Report on Form 10-K for the period ended December
31, 2014, and subsequent filings with the Securities and Exchange
Commission. The forward-looking statements in this press release
represent NewLink's views as of the date of this press release.
NewLink anticipates that subsequent events and developments will
cause its views to change. However, while it may elect to update
these forward-looking statements at some point in the future, it
specifically disclaims any obligation to do so. You should,
therefore, not rely on these forward-looking statements as
representing NewLink's views as of any date subsequent to the date
of this press release.
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Merck Media:Pam Eisele, 267-305-3558orImraan Munshi,
215-652-0059Investor:NewLink Genetics:Jack Henneman,
515-598-2561orMerck:Justin Holko, 908-740-1879
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