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
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