NewLink Genetics Corporation Announces Clinical Development Milestone Achieved With Merck for Ebola Vaccine Candidate
20 February 2015 - 12:30AM
NewLink Genetics Corporation (Nasdaq:NLNK) today announced that it
had received notification from Merck (NYSE:MRK) that the milestone
event specified in the license and collaboration agreement between
the two companies relating to the further development of the
rVSV-EBOV (Ebola) vaccine candidate had been achieved. Under the
terms of the agreement, NewLink Genetics will receive a payment of
$20 million in connection with the achievement of the
milestone. The milestone pertains to the initiation of a key
clinical trial for the vaccine.
"We at NewLink very much appreciate the tremendous support for
these studies that we have received from our collaboration
partners, including Merck, the government of Canada and the US
Department of Health and Human Services (Centers for Disease
Control, the National Institutes of Health and the Biomedical
Advanced Research and Development Authority), the US Department of
Defense, and the World Health Organization, each of which has made
critical contributions along the way," said Dr. Charles Link,
Chairman, Chief Executive Officer, and Chief Scientific Officer of
NewLink Genetics. "We hope that the initiation of large scale
clinical trials in Africa represent another step forward toward
finding a solution for this difficult, global problem. This
milestone payment will help us continue our significant investment
into vaccines for infectious diseases, including Ebola in
collaboration with Merck."
The rVSV-EBOV vaccine candidate was originally developed by the
Public Health Agency of Canada (PHAC), and licensed by
BioProtection Systems, Inc., a wholly-owned subsidiary of NewLink
Genetics Corporation. PHAC will be entitled to a payment
from NewLink Genetics in connection with this milestone.
On November 24, 2014, Merck, known as MSD outside the United
States and Canada, announced that it had entered into an exclusive
worldwide license agreement with NewLink Genetics pursuant to which
Merck obtained an exclusive license to research, develop,
manufacture, and distribute the investigational rVSV-EBOV (Ebola)
vaccine candidate as well as any follow-on products.
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 rVSV Vaccine Platform
This vaccine platform is based on attenuated strains of
vesicular stomatitis virus, a common animal virus, modified to
express an Ebola virus protein that is non-pathologic 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.
On November 24, 2014, Merck, known as MSD outside the United
States and Canada, announced that it had entered into an exclusive
worldwide license agreement with NewLink Genetics pursuant to which
Merck obtained an exclusive license to research, develop,
manufacture, and distribute the investigational rVSV-EBOV (Ebola)
vaccine candidate as well as any follow-on products.
Cautionary Note Regarding Forward-Looking
Statements
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 the following: plans to develop 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.
CONTACT: Investor Contact:
Jack Henneman
Chief Financial Officer
(515) 598-2561
Investor@linkp.com
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