NewLink Genetics Announces EU Regulatory Committee (CHMP) Recommendation for Conditional Marketing Authorization for Ebola Va...
21 Octubre 2019 - 3:30PM
NewLink Genetics Corporation (NASDAQ:NLNK) announced today that
Friday, October 18th, the European Medicines Agency (EMA) Committee
for Medicinal Products for Human Use (CHMP) adopted a positive
opinion recommending a conditional marketing authorization for
investigational V920 Ebola Zaire vaccine (rVSV∆G-ZEBOV-GP), as
confirmed by our partner, Merck & Co., Inc. (NYSE:MRK). This
Committee recommendation will now be reviewed by the European
Commission (EC) which, if it chooses to affirm the CHMP’s
recommendation, will grant a centralized marketing authorization of
the vaccine (brand name ERVEBO®) under a unified label valid in 31
European countries.
This opinion issued by the CHMP follows the recent announcement
by the FDA that it has accepted the Biologics License Application
(BLA) and granted priority review for the investigational Ebola
vaccine (V920). As previously reported, the Prescription Drug User
Fee Act (PDUFA), or target FDA action date, is set for March 14,
2020. Should this vaccine be approved by the FDA, a monetizable
Priority Review Voucher (PRV) would be issued, in which NewLink
Genetics owns a substantial financial interest.
“We are delighted by this EMA Committee opinion supporting the
conditional marketing authorization of our partnered Ebola virus
vaccine,” commented Carl Langren, Chief Financial Officer and
member of NewLink Genetics’ Office of the CEO. “We believe the
Committee’s positive opinion represents further recognition of the
critical nature of this Ebola outbreak and signifies the urgency
with which regulatory bodies are addressing the severe risk this
disease poses to a worldwide population.”
About NewLink Genetics Corporation
NewLink Genetics is a clinical stage biopharmaceutical company
focused on developing novel oncology product candidates to improve
the lives of patients with cancer where treatment options are
limited. NewLink Genetics' IDO pathway inhibitors, indoximod and
its prodrug, NLG802, are immuno-oncology drug candidates designed
to harness multiple components of the immune system to combat
cancer. For more information, please visit
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 contained in this press release are
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. The words “will,” "if,"
“should,” “would,” “set for,” 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 about results of NewLink’s clinical trials
for 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 Genetics
makes due to a number of important factors, including those risks
discussed in "Risk Factors" and elsewhere in NewLink Genetics'
Quarterly Report on Form 10-Q for the quarter ended June 30, 2019
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.
Investor & Media Contact:
Lisa MillerDirector of Investor RelationsNewLink
Genetics515-598-2555lmiller@linkp.com
Source: NewLink Genetics Corporation
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