NewLink Genetics Announces Merck Receives Breakthrough Therapy Designation from FDA and PRIME Status from EMA for Investigati...
July 25 2016 - 08:05AM
NewLink Genetics Corporation (NASDAQ:NLNK), announced today
that Merck (NYSE:MRK), known as MSD outside the United States and
Canada, has reached two key regulatory milestones for the Ebola
Zaire vaccine candidate known as V920 (rVSV∆G-ZEBOV-GP). The U.S
Food and Drug Administration (FDA) has granted the vaccine
candidate Breakthrough Therapy Designation, and the European
Medicines Agency (EMA) has provided the vaccine candidate PRIME
(
PRIority
MEdicines)
status.
V920 was initially engineered by scientists from the Public
Health Agency of Canada and subsequently licensed to NewLink
Genetics. In late 2014, when the peak of the Ebola outbreak in
western Africa was at its worst, NewLink Genetics licensed V920 to
Merck, with the goal of accelerating the development, regulatory
approval, and availability of this candidate vaccine. Merck is
responsible for the research, development, manufacturing, and
regulatory efforts in support of V920. Since that time, Merck
continues to work closely with NewLink Genetics and their external
collaborators to accelerate development and licensure.
“These regulatory designations reflect great credit upon the
extraordinary public-private partnerships which have allowed the
vaccine candidate to be included in 12 Phase 1, 2 and 3 studies on
three continents in less than two years,” said Thomas P. Monath,
M.D., Chief Scientific Officer and Chief Operating Officer of the
Infectious Disease Division of NewLink Genetics. Charles L. Link,
Jr., M.D., Chairman, Chief Executive Officer and Chief Scientific
Officer of NewLink Genetics emphasized that, “While the Ebola
Public Health Emergency of International Concern (PHEIC) is over,
we know the threat of re-emergence remains. We are encouraged by
these FDA and EMA decisions which we hope will aid progress of the
candidate vaccine towards potential licensure.”
About NewLink Genetics
Corporation
NewLink Genetics is a biopharmaceutical company at the forefront
of discovering, developing and commercializing novel
immuno-oncology product candidates, including both cellular
immunotherapy and checkpoint inhibitor platforms, to improve the
lives of 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. 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 any 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 Contact:
Beth Kurth
LaVoieHealthScience
617-374-8800, ext. 106
bkurth@lavoiehealthscience.com
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