NewLink Genetics Announces FDA Approval of Ebola Vaccine V920 (ERVEBO®)
December 20 2019 - 10:09AM
NewLink Genetics Corporation (NASDAQ:NLNK) announced today that,
after priority review, the FDA has granted approval of ERVEBO®, or
Zaire Ebola virus vaccine V920 (rVSV∆G-ZEBOV-GP), as confirmed by
our partner, Merck (NYSE:MRK), known as MSD outside the US and
Canada. This represents the first vaccine approved by the FDA for
the Ebola virus and follows the November 11th grant by the European
Commission (EC) of a marketing authorization for ERVEBO® across 31
European countries.
Yesterday’s approval comes almost three months
prior to the Prescription Drug User Fee Act (PDUFA), or target FDA
action date, originally set for March 14, 2020. As NewLink has
previously stated, the FDA’s approval of this Ebola vaccine will
trigger the issuance of a priority review voucher (PRV) owned by
Merck and in which NewLink Genetics has a substantial economic
interest. Thereafter, NewLink will have the right to monetize its
share of interest in the voucher.
“We are delighted by the FDA’s decision to approve
this Ebola vaccine and by the agency’s recognition of the potential
this vaccine may offer to protect individuals who may be exposed to
Ebola from contracting this deadly disease,” commented Eugene
Kennedy, MD, Chief Medical Officer and member of NewLink Genetics’
Office of the CEO. “We are grateful to our partner Merck, and to
the regulatory bodies involved, for their dedication to advancing
solutions to combat this deadly illness.”
ERVEBO® is a registered trademark of Merck Sharp
& Dohme Corp (“Merck”)
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’s 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.
Information Regarding the Proposed Merger
with Lumos and Where to Find It
In connection with the proposed merger (the
"Merger") among NewLink, Cyclone Merger Sub, Inc.,
a Delaware corporation and wholly-owned subsidiary of the
Company (the "Merger Sub"), and Lumos, pursuant to the terms of the
Agreement and Plan of Merger dated September 30, 2019 (the
“Lumos Merger Agreement”) by and among NewLink, Merger Sub and
Lumos, the Company intends to file relevant materials with
the Securities and Exchange Commission (the “SEC”),
including a proxy statement for its stockholders containing the
information with respect to the Merger and the Lumos Merger
Agreement specified in Schedule 14A promulgated under the
Securities Exchange Act of 1934, as amended and describing the
proposed Merger. The proxy statement and other relevant materials
(when they become available), and any other documents filed by the
Company with the SEC, may be obtained free of charge at
the SEC website at www.sec.gov. In addition, investors
and security holders may obtain free copies of the documents filed
with the SEC by the Company by directing a written
request to: NewLink Genetics Corporation, 2503 South Loop
Drive, Ames, IA 50010. Investors and security holders are
urged to read the proxy statement and the other relevant materials
when they become available before making any voting or investment
decision with respect to the Merger.
Participants in the
Solicitation
The Company and its directors and executive
officers and Lumos and its directors and executive officers may be
deemed to be participants in the solicitation of proxies from the
stockholders of the Company in connection with the proposed
transaction. Information regarding the special interests of these
directors and executive officers in the merger will be included in
the proxy statement referred to above. Additional information
regarding the directors and executive officers of the Company is
also included in the Company’s Annual Report on Form 10-K for the
year ended December 31, 2018 and the proxy statement for
the Company’s 2019 Annual Meeting of Stockholders. These documents
are available free of charge at the SEC web site
(www.sec.gov) and from the Company at the address described
above.
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
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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