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8-K - CURRENT REPORT - NRX Pharmaceuticals, Inc. | brpa_8k.htm |
Exhibit 99.1
NeuroRx and Georgian Ministry of Health Agree to
Initiate Expanded Access Program of ZYESAMI (aviptadil acetate) for
COVID-19 Respiratory Failure in
Georgia
RADNOR,
Pa. and TBLISI, Georgia, April 28,
2021 /PRNewswire/ -- NeuroRx today announces that it has
met with Dr. Ekaterine Tikaradze, Minister of Health
of Georgia, and other senior leadership, to immediately
initiate an Expanded Access Program (EAP) of its phase 3 drug,
ZYESAMI (aviptadil acetate) for critically-ill citizens
of Georgia with COVID-19 Respiratory Failure. The
EAP will be conducted in collaboration with Denk Pharma
Georgia, Georgia's primary pharmaceutical distributor,
and under the auspices of the Potomac Institute of Policy Studies
and the Richard G. Lugar Center for Public Health Research, a
research facility funded by the U.S. Defense Threat Reduction
Agency and named in honor of former U.S. Senator Richard G.
Lugar to support international research efforts in its
endeavor to stop global diseases.
The
Georgian Ministry of Health has granted approval for the EAP
approved by the US FDA (www.clinicaltrials.gov NCT04453839) to
be initiated in Georgia and potentially in other
neighboring countries in the Caucasus Region under the oversight of
the Georgian Ministry of Health.
Minister
Tikaradze said, "We
in Georgia are enthusiastic about Dr. Anthony
Fauci's recent announcement of NeuroRx and ZYESAMI as an
industry partner in the NIH ACTIV3b trial. We are pleased to initiate an Expanded Access
Program of ZYESAMI in Georgia under our oversight with
the participation of Denk Pharma Georgia and the Lugar Center for
Public Health Research."
"As the world braces for another surge of COVID-19 and its
variants, we at NeuroRx are honored to have been selected by the
Ministry of Health of Georgia as part of their strategy
to safeguard their citizens," said Prof. Jonathan
Javitt, CEO and Chairman of NeuroRx. "In the coming weeks, we look forward to
announcing broader programs involving immunization strategies as
well as COVID-19 therapeutics to serve the people of the Caucasus
Region."
NeuroRx
has signed an agreement to merge with Big Rock Partners Acquisition
Corp (Nasdaq:BRPA).
Please see "Additional Information and Where to Find It" below for
additional information related to the merger.
About NeuroRx, Inc.
NeuroRx
draws upon more than 100 years of collective drug development
experience from senior executives of AstraZeneca, Eli Lilly,
Novartis, Pfizer, and PPD. In addition to its work on Aviptadil,
NeuroRx has been awarded Breakthrough Therapy Designation and a
Special Protocol Agreement to develop NRX-101 in suicidal bipolar
depression and is currently in Phase 3 trials. Its executive team
is led by Prof. Jonathan C. Javitt, MD, MPH, who has served as
a health advisor to four Presidential administrations and worked on
paradigm-changing drug development projects for Merck, Allergan,
Pharmacia, Pfizer, Novartis, and Mannkind, together
with Robert Besthof, MIM, who served as the Global Vice
President (Commercial) for Pfizer's Neuroscience and Pain
Division. NeuroRx recently announced a plan to complete a
business combination with Big Rock Partners Acquisition Corp
(NASDAQ:BRPA) ("BRPA"), and
intends to apply for listing on the NASDAQ under the proposed
symbol "NRXP".
Cautionary Note Regarding Forward Looking Statements
Statements
contained in this press release that are not historical facts may
be forward-looking statements within the meaning of Section 27A of
the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. Forward-looking statements generally relate
to future events or NeuroRx's future financial or operating
performance. In some cases, you can identify forward-looking
statements because they contain words such as "may," "will,"
"should," "expects," "plans," "anticipates," "could," "intends,"
"target," "projects," "contemplates," "believes," "estimates,"
"predicts," "potential" or "continue" or the negative of these
words or other similar terms or expressions that concern NeuroRx's
expectations, strategy, plans or intentions. Such forward-looking
statements may relate to, among other things, the outcome of any
discussions or applications for the future use of ZYESAMI, the
approvals, timing, and ability to complete the proposed business
combination with BRPA, and the combined company's ability to
continue listing on Nasdaq after closing the proposed business
combination. Such forward-looking statements do not constitute
guarantees of future performance and are subject to a variety of
risks and uncertainties. NeuroRx does not undertake any obligation
to update forward-looking statements as a result of new
information, future events or developments or
otherwise.
Additional Information and Where to Find It
This
press release relates to a proposed business combination and
related transactions (the "Transactions") between NeuroRx and BRPA.
This press release does not constitute an offer to sell or
exchange, or the solicitation of an offer to buy or exchange, any
securities, nor shall there be any sale of securities in any
jurisdiction in which such offer, sale or exchange would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. BRPA has filed a
registration statement on Form S-4 ("Registration Statement"),
which includes a preliminary proxy statement for the solicitation
of the approval of BRPA's stockholders, a preliminary prospectus
for the offer and sale of BRPA's securities in the Transactions and
a preliminary consent solicitation statement of NeuroRx, and other
relevant documents with the SEC. The proxy
statement/prospectus/consent solicitation statement will be mailed
to stockholders of NeuroRx and BRPA as of a record date to be
established for voting on the proposed business combination.
INVESTORS AND SECURITY HOLDERS OF NEURORX AND BRPA ARE URGED TO
READ THE REGISTRATION STATEMENT, PROXY STATEMENT/PROSPECTUS/CONSENT
SOLICITATION STATEMENT AND OTHER RELEVANT DOCUMENTS THAT WILL BE
FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME
AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE
PROPOSED TRANSACTIONS. Investors and security holders will be able
to obtain free copies of the registration statement, proxy
statement, prospectus and other documents containing important
information about NeuroRx and BRPA once such documents are filed
with the SEC, through the website maintained by the SEC
at http://www.sec.gov. In
addition, copies of the documents filed with the SEC by BRPA can be
obtained free of charge on BRPA's website at www.bigrockpartners.com or by
directing a written request to BRPA at 2645 N. Federal Highway,
Suite 230 Delray Beach, FL 33483.
Participants in the Solicitation
NeuroRx,
BRPA and their respective directors and executive officers, under
SEC rules, may be deemed to be participants in the solicitation of
proxies of BRPA's stockholders in connection with the proposed
Transactions. Investors and securityholders may obtain more
detailed information regarding the names and interests in the
proposed Transactions of NeuroRx's and BRPA's respective directors
and officers in BRPA's filings with the SEC, including the proxy
statement/consent solicitation statement/prospectus statement. You
may obtain a free copy of these documents as described in the
preceding paragraph.
CORPORATE CONTACT
Jonathan
C. Javitt, M.D., MPH
Chairman
& Chief Executive Officer
ceo@nrxpharma.com
INVESTOR RELATIONS
Ryan
Sheffield
rsheffield@nrxpharma.com
(484)
254-6134, ext. 723
MEDIA RELATIONS
Greg
Parasmo
gparasmo@nrxpharma.com
(484)
254-6134, ext. 724