NewLink Genetics Awarded $25 Million Contract from BARDA for Investigational Ebola Zaire Vaccine (V920)
October 04 2016 - 3:10PM
NewLink Genetics Corporation (NASDAQ:NLNK), announced today that
the Biomedical Advanced Research and Development Authority (BARDA)
of the United States Department of Health and Human Services (HHS)
has issued a $24.8 million contract to a subsidiary of NewLink
Genetics to support the advanced development of the investigational
rVSV∆G-ZEBOV GP (Ebola Zaire) vaccine candidate, designated V920.
The new award includes an additional $51 million of
contract options which may be exercised by BARDA. BARDA has
previously awarded $76.8 million in contracts for development of
V920. The new funding is in support of manufacturing facility
readiness, manufacturing process qualification activities, and
additional clinical trials to support regulatory approval of the
V920 vaccine.
Merck (NYSE:MRK), known as MSD outside the United
States and Canada, has the exclusive worldwide license for
research, development, manufacturing and distribution of the
rVSV∆G-ZEBOV GP (Ebola Zaire) vaccine. In July 2016, the two
companies reported on two key regulatory milestones for V920.
The U.S Food and Drug Administration (FDA) granted the V920
Breakthrough Therapy Designation, and the European Medicines Agency
(EMA), PRIME (PRIority MEdicines)
status.
“This new contract issued by BARDA will enable
accelerated full-scale production of V920, once it is
approved, and is a critical step in helping to make this
vaccine available to the health care community as they work to
control epidemics and protect medical workers and others at high
risk," said Thomas P. Monath, MD, Chief Scientific Officer and
Chief Operating Officer of the Infectious Disease Division of
NewLink Genetics.
The rVSV∆G-ZEBOV GP (Ebola Zaire) vaccine candidate
was originally engineered by scientists at the Public Health
Agency of Canada (PHAC) and was subsequently licensed to NewLink
Genetics. In late 2014, Merck licensed the vaccine
from NewLink Genetics to apply Merck's vaccine expertise to
help accelerate the development of this vaccine candidate. Merck is
responsible for and involved in the research, development,
manufacturing, distribution and regulatory efforts in support of
V920. Clinical studies of the vaccine candidate are
ongoing.
About NewLink Genetics
Corporation
NewLink Genetics is a biopharmaceutical company
focused on discovering, developing and commercializing novel
immuno-oncology products to improve treatment options for patients
with cancer. NewLink Genetics’ portfolio includes biologic and
small-molecule immunotherapy product candidates intended to treat a
wide range of oncology indications. NewLink Genetics’ 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.newlinkgenetics.com.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking
statements of NewLink Genetics 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, enrollment in or results of its clinical trials for
product candidates; its timing of release of data from ongoing
clinical studies; 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 Genetics makes due to a
number of important factors, including those risks discussed in
“Risk Factors” and elsewhere in NewLink Genetics’ Annual Report on
Form 10-K for the year ended December 31, 2015 and other reports
filed with the U.S. Securities and Exchange Commission (SEC). The
forward-looking statements in this press release represent NewLink
Genetics’ views as of the date of this press release. NewLink
Genetics 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 Genetics’ views as of any date subsequent to
the date of this press release.
Corporate Contact:
Jack Henneman
Chief Financial Officer
(515) 598-2561
Investor@linkp.com
Media and Investor Contacts:
Media
Ben Navon
LaVoieHealthScience
617-374-8800, ext. 108
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Investors
Beth Kurth
LaVoieHealthScience
617-374-8800, ext. 106
bkurth@lavoiehealthscience.com
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