Clinical Development, Manufacturing Expertise, and Scale Critical to
Success
WHITEHOUSE STATION, N.J. & AMES, IA--(BUSINESS WIRE)--
Merck (NYSE:MRK), known as MSD outside the United States and Canada, and
NewLink Genetics Corporation (NASDAQ:NLNK), announced today that they
have entered into an exclusive worldwide license agreement to research,
develop, manufacture, and distribute NewLink's investigational rVSV-EBOV
(Ebola) vaccine candidate.
The vaccine candidate, originally developed by the Public Health Agency
of Canada (PHAC), is currently being evaluated in Phase I clinical
trials. Pending the results of ongoing Phase I trials the U.S. National
Institutes of Health (NIH) has announced plans to initiate, in early
2015, a large randomized, controlled Phase III study to evaluate the
safety and efficacy of the rVSV-EBOV vaccine and another investigational
Ebola vaccine co-developed by the National Institute of Allergy and
Infectious Diseases (NIAID) and GlaxoSmithKline.
"Effective Ebola vaccines will be a critical component of comprehensive
prevention and control measures for people at risk of Ebola virus
infection and to stem future outbreaks globally," said Dr. Julie
Gerberding, president of Merck Vaccines. "Merck is committed to applying
our vaccine expertise to address important global health needs and,
through our collaboration with NewLink, we hope to advance the public
health response to this urgent international health priority."
According to Dr. Charles Link, chairman and chief executive officer of
NewLink Genetics, "Merck's vaccine development expertise, commercial
leadership and history of successful strategic alliances make it an
ideal partner to expedite the development of rVSV-EBOV and, if
demonstrated to be efficacious and well-tolerated, to make it available
to individuals and communities at risk of Ebola virus infection around
the world."
Under the terms of the agreement, Merck will be granted the exclusive
rights to the rVSV-EBOV vaccine candidate as well as any follow-on
products. The vaccine candidate is under an exclusive licensing
arrangement with a wholly-owned subsidiary of NewLink Genetics. Under
these license arrangements, the PHAC retains non-commercial rights
pertaining to the vaccine candidate.
Phase I clinical trials of the rVSV-EBOV vaccine are now underway at the
Walter Reed Army Institute of Research and the NIAID at the NIH.
Additional Phase I studies are underway or planned to begin in the near
future at clinical research centers in Switzerland, Germany, Kenya, and
Gabon in a World Health Organization-coordinated effort, and in Canada
by the Canadian Immunization Research Network.
"This vaccine is the result of years of hard work and innovation by
Canadian scientists. We are pleased that this new alliance coupled with
the clinical trials currently underway will further strengthen the
possibility that the vaccine will make a difference in the global
response to the Ebola outbreak," said Canada's Minister of Health, Rona
Ambrose.
About rVSV Vaccine Platform
This vaccine platform is based on an attenuated strain of vesicular
stomatitis virus that has been modified to express an Ebola virus
protein that plays an essential role in establishing virus infection.
The rVSV-EBOV vaccine was created by scientists at the Public Health
Agency of Canada's National Microbiology Laboratory. A significant
portion of the funding for the further development of the vaccine came
from the CBRN Research and Technology Initiative, a federal program led
by Defence Research and Development Canada. In 2010, the PHAC signed a
licensing arrangement with BioProtection Systems (BPS), a wholly-owned
subsidiary of NewLink Genetics, as the sole licensee for these vaccines
and the underlying technology. BPS has worked with the PHAC to produce
clinical trial materials and to move this vaccine candidate into Phase I
studies.
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 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; 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; 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 2013 Annual Report on Form 10-K and the company's other
filings with the 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,
2013, 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 Contacts:
Pam Eisele, 267-305-3558
Imraan
Munshi, 215-652-0059
or
Investor Contacts:
NewLink
Genetics
Jack Henneman, 515-598-2561
or
Merck
Justin
Holko, 908-423-5088
Source: Merck
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