- Company to receive first allocation of ketamine for sale by
month end
- Partners preparing to ship IV Ketamine to full range of
customers via 503a and 503b
pharmacies
- NRx Pharmaceuticals and HOPE Therapeutics aim to provide
highest quality product available to those in need and assure
ongoing supply
- Important step toward goal of providing full suite of supply
options, to ultimately include an FDA approved, and widely
reimbursed, solution for patients and clinics, subject to board
approval
RADNOR,
Pa., March 11, 2024 /PRNewswire/ -- NRx
Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", the
"Company") and its wholly owned subsidiary HOPE Therapeutics,
clinical-stage biopharmaceutical companies, today announced
completion of a Memorandum of Understanding with Conversio
Health, a national 503a pharmacy, and a strong, ongoing partnership
with Nephron Pharmaceuticals, a manufacturer of Ketamine and
503b pharmacy to provide IV Ketamine
to patients and clinics across the country, subject to board
approval. These are important steps to providing a full suite
of ketamine options for customers across the country, and
preparation for potential approval of HTX-100 by regulatory
authorities worldwide.
The Company has further entered into a business relationship
with an organization that currently serves the business needs of
more than 100 ketamine clinics nationwide. The Company has
been given a target delivery date prior to the end of this month
(March 2024) for initial stock of
ketamine for sale to licensed end users. Sales are planned to
commence once technical and logistical elements are
finalized. Details for ordering will be available on our
website as soon as they are available. www.hopetherapeutics.com
In contrast to NRx Pharmaceuticals, which is structured as a
Biotechnology research and development company, HOPE Therapeutics
is structured as a Specialty Pharmaceutical company that aims to
supply a variety of therapeutic products to clinics that are
treating suicidal depression and PTSD, including both traditional
and digital therapeutics.
"We are pleased to be working with two outstanding organizations
in Conversio Health and Nephron Pharmaceuticals to provide this
important medication to a market in need of a consistent supply of
high-quality, FDA- and DEA- compliant IV ketamine," said
Matthew Duffy Chief Business Officer
of NRx Pharmaceuticals and co-CEO of HOPE Therapeutics.
"Importantly, these efforts will provide a strong foundation for
expanding our product offering with our planed filing a New Drug
Application with the FDA in the coming months, and the potential
launch of HTX-100 in early 2025." The NDA filing currently
awaits completion of an additional three months of product
stability.
About NRx Pharmaceuticals
NRx Pharmaceuticals is a clinical-stage biopharmaceutical
company developing therapeutics based on its NMDA platform for the
treatment of central nervous system disorders, specifically
suicidal bipolar depression, chronic pain and PTSD. The Company is
developing NRX-101, an FDA-designated investigational Breakthrough
Therapy for suicidal treatment-resistant bipolar depression and
chronic pain. NRx has partnered with Alvogen and Lotus around the
development and marketing of NRX-101 for the treatment of suicidal
bipolar depression. NRX-101 additionally has potential to act as a
non-opioid treatment for chronic pain, as well as a treatment for
complicated UTI.
NRx has recently announced plans to submit a New Drug
Application for HTX-100 (IV ketamine), through HOPE Therapeutics,
in the treatment of suicidal depression, based on results of
well-controlled clinical trials conducted under the auspices of the
US National Institutes of Health and newly obtained data from
French health authorities, licensed under a data sharing
agreement. NRx was awarded Fast Track Designation for
development of ketamine (NRX-100) by the US FDA as part of a
protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a
Specialty Pharmaceutical Company, wholly-owned by NRX
Pharmaceuticals focused on development and marketing of an
FDA-approved form of intravenous ketamine for the treatment of
acute suicidality and depression together with a digital
therapeutic-enabled platform designed to augment and preserve the
clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking
statements within the meaning of Section 21E of the Securities
Exchange Act of 1934, as amended, and Section 27A of the Securities
Act of 1933, as amended. These statements include, among others,
statements regarding the proposed public offering and the timing
and the use of the proceeds from the offering. Forward-looking
statements generally include statements that are predictive in
nature and depend upon or refer to future events or conditions, and
include words such as "may," "will," "should," "would," "expect,"
"plan," "believe," "intend," "look forward," and other similar
expressions among others. These statements relate to future events
or to the Company's future financial performance, and involve known
and unknown risks, uncertainties and other factors that may cause
the Company's actual results to be materially different from any
future results, levels of activity, performance or achievements
expressed or implied by these forward-looking statements. You
should not place undue reliance on forward-looking statements since
they involve known and unknown risks, uncertainties and other
factors which are, in some cases, beyond the Company's control and
which could, and likely will, materially affect actual results,
levels of activity, performance or achievements. Any
forward-looking statement reflects the Company's current views with
respect to future events and is subject to these and other risks,
uncertainties and assumptions relating to the Company's operations,
results of operations, growth strategy and liquidity. More detailed
information about the Company and the risk factors that may affect
the realization of forward-looking statements is set forth in the
Company's most recent Annual Report on Form 10-K and other filings
with the Securities and Exchange Commission. Investors and security
holders are urged to read these documents free of charge on the
SEC's website at http://www.sec.gov. Except as may be required
by applicable law, The Company assumes no obligation to publicly
update or revise these forward-looking statements for any reason,
or to update the reasons actual results could differ materially
from those anticipated in these forward-looking statements, whether
as a result of new information, future events or otherwise.
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SOURCE NRx Pharmaceuticals, Inc.