NewLink Genetics Corporation (Nasdaq:NLNK) and Merck (NYSE:MRK),
known as MSD outside the United States and Canada, announced today
that the Biomedical Advanced Research and Development Authority
(BARDA) of the United States Department of Health and Human
Services (HHS) has awarded NewLink Genetics' wholly-owned
subsidiary, BioProtection Systems, as the prime contractor in a $30
million contract to support the manufacturing and development
activities of its investigational rVSV-EBOV (Ebola) vaccine
candidate, including clinical development through a new 330-person
Phase Ib study.
The vaccine candidate was initially developed by the Public
Health Agency of Canada (PHAC), and is now being developed under an
exclusive licensing and collaboration agreement between NewLink
Genetics and Merck. The rVSV-EBOV (Ebola) vaccine candidate is
currently being evaluated in Phase I clinical studies in
humans.
"The current funding provided by BARDA is key to the rapid
development of this Ebola vaccine candidate. These funds will
support multiple facets of the accelerated Ebola vaccine program
including the expansion of critical vaccine supplies and larger
clinical studies," said Dr. Charles Link, CEO and Chief Scientific
Officer of NewLink Genetics.
"Governments and industry are effectively collaborating in an
unprecedented effort to accelerate the development of Ebola vaccine
candidates," said Dr. Mark Feinberg, chief public health and
science officer of Merck Vaccines. "If we can bring an efficacious
and well-tolerated vaccine to the outbreak countries, we will not
only help protect people at risk in the current crisis, but also
may help reduce the likelihood of such tragic events in the
future."
Pending the results of Phase I trials underway, the US National
Institutes of Health has announced plans to initiate, in early
2015, a large randomized, controlled Phase II/III study to evaluate
the safety and efficacy of this and another investigational Ebola
vaccine candidate.
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. For more information
please visit http://www.linkp.com.
About BioProtection Systems Corporation
BioProtection Systems (BPS), 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. BPS is based
on three core technologies that can be leveraged into the
infectious disease or biodefense fields. The first technology is a
replication-competent recombinant vesicular stomatitis virus, or
rVSV, an advanced vaccine technology developed for the Marburg and
Ebola viruses. The second is our HyperAcute® immunotherapy
technology, which is currently focused on enhancing vaccines for
influenza but can be adapted to a number of vaccines. The third
technology is based on the yellow fever virus vaccine strain.
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 rVSV Vaccine Platform
This vaccine platform is based on attenuated strains of
vesicular stomatitis virus, a common animal virus, that has been
modified to express an Ebola virus protein and which is
non-pathogenic in primates and mice. This vaccine was initially
developed by the Public Health Agency of Canada (PHAC) with a
significant portion of the funding coming from the CBRN Research
and Technology Initiative, a federal program led by Defence
Research and Development Canada, the research arm of Canada's
Department of National Defence, which funded work at the PHAC's
National Microbiological Laboratory resulting in the creation of
the experimental vaccine, rVSV-ZEBOV-GP (BPSC1001). In 2010, 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.
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.
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).
CONTACT: Merck Media Contacts:
Pam Eisele
(267) 305-3558
Imraan Munshi
(215) 652-0059
Investor Contacts:
NewLink Genetics:
Jack Henneman
(515) 598-2561
Merck:
Justin Holko
(908) 740-1879
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