NewLink Genetics Announces European Commission Grant of Conditional Marketing Approval for Ebola Vaccine V920 (ERVEBO®)
November 12 2019 - 9:00AM
NewLink Genetics Corporation (NASDAQ:NLNK) announced that Monday,
November 11th, the European Commission (EC) granted a conditional
marketing authorization to ERVEBO®, investigational V920 Ebola
Zaire vaccine (rVSV∆G-ZEBOV-GP), as confirmed by our partner, Merck
(NYSE:MRK), known as MSD outside the US and Canada. With this
approval, the EC will grant a centralized marketing authorization
for the vaccine with unified labeling that is valid in 31 European
countries.
The granting of this approval by the EC follows the September
17th announcement by the FDA that it has accepted the Biologics
License Application (BLA) and granted priority review for the
investigational Ebola vaccine (V920). The Prescription Drug User
Fee Act (PDUFA), or target FDA action date, is set for March 14,
2020. As NewLink has previously stated, the FDA’s approval of this
Ebola vaccine would trigger the issuance of a priority review
voucher owned by Merck and in which NewLink Genetics has a
substantial economic interest. Thereafter, NewLink would have the
right to monetize its share of interest in the voucher.
“We are thrilled by the EC’s decision to approve this Ebola
vaccine, offering the potential for protection from this
devastating disease,” noted Eugene Kennedy, MD, Chief Medical
Officer and member of NewLink Genetics’ Office of the CEO. “We are
also grateful to our partner Merck, and to the regulatory bodies
involved for their diligent efforts to advance solutions to combat
this deadly illness.”
About NewLink Genetics Corporation
NewLink Genetics is a clinical-stage biopharmaceutical company
that has historically focused on developing novel immunotherapeutic
products for the treatment of patients with cancer. On September
30, 2019, NewLink announced its intent to merge with Lumos Pharma,
a private clinical-stage biopharmaceutical company targeting rare
and neglected diseases. At the close of the proposed merger, the
combined company will operate as Lumos Pharma focused on Lumos’
sole product candidate, LUM-201 (ibutamoren), an oral growth
hormone (GH) secretagogue targeting pediatric growth hormone
deficiency (PGHD) and other rare endocrine disorders. If approved,
LUM-201 has the potential to represent the first orally
administered growth hormone stimulating therapy for a subset of
PGHD patients, an established market where daily recombinant human
growth hormone injections represent the current standard-of-care
treatment regimen. 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
“forecast,” “projected,” "guidance," "upcoming," "will," "plan,"
“intend,” "anticipate," "approximate," "expect," “potential,” 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 expectation regarding the centralized marketing
authorization to be granted by the EC; the PDUFA date; NewLink’s
right to monetize its share of the priority review voucher owned by
Merck; 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 the risks related to the ability to
monetize and realize the anticipated benefits of the priority
review voucher and risks that the conditional authorization does
not covert into a standard marketing authorization. Further
risks that could cause actual results to differ materially from
those matters expressed in or implied by such forward-looking
statements are discussed in "Risk Factors" and elsewhere
in NewLink Genetics' Quarterly Report on Form 10-Q for
the quarter ended September 30, 2019 and other reports
filed with the 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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