Phase III Trial of the Merck and NewLink Genetics Investigational Ebola Vaccine Initiated in Sierra Leone


April 14, 2015 12:30 pm ET

rVSV-ZEBOV-GP (V920) Now Being Studied in Three Key Safety and Efficacy Clinical Trials

KENILWORTH, N.J. & AMES, Iowa–(BUSINESS WIRE)–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

“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,
and connect with us on Twitter,
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

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 (

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.

Merck Media:
Pam Eisele, 267-305-3558
Imraan Munshi, 215-652-0059
NewLink Genetics:
Jack Henneman, 515-598-2561
Justin Holko, 908-740-1879

Unsubscribe from email alerts