RADNOR, Pa., Aug. 26, 2021 /PRNewswire/ -- NRx Pharmaceuticals
(NRx) (Nasdaq: NRXP) announced today it has signed an agreement
with Cardinal Health to provide third party logistics and
distribution of ZYESAMI™ upon the potential Emergency Use
Authorization (EUA) approval by the US Food and Drug Administration
(FDA). In May, NRx submitted an application for EUA to the FDA for
ZYESAMI™ (aviptadil) for patients suffering from Critical COVID-19
with respiratory failure.
This partnership creates an efficient and highly flexible logistics
and distribution model for NRx.
"This partnership creates an efficient and highly flexible
logistics and distribution model for NRx. Cardinal Health's
expertise will enable ZYESAMI to quickly reach patients in the
intensive care units, as limiting the time to treatment is
crucial," said Robert Besthof, Head
of Operations and Chief Commercial Officer of NRx. "This also
allows NRx to continue focusing on answering requests from the FDA
in support of our application for Emergency Use Authorization for
ZYESAMI."
Cardinal Health Specialty Pharmaceutical Distribution will serve
as the exclusive distributor for ZYESAMI, providing broad access to
hospitals for this needed medicine upon FDA authorization. With one
of the largest healthcare supply chains, Cardinal Health services
more than 90% of hospitals in the U.S., and has more than 20 years
of experience supporting rapid delivery of lifesaving
medicines.
Additionally, Cardinal Health's Third-Party Logistics Services
(3PL) will support the warehousing and distribution, full order to
cash, and necessary title model services.
"As the COVID-19 pandemic continues, so does the need for more
innovative, effective and FDA-approved therapies for critically-ill
patients with respiratory failure," said Marc DeLorenzo, Senior Vice President of
Strategic Sourcing at Cardinal Health. "Cardinal Health is pleased
to ensure that COVID-19 patients get access to treatment in a
timely and efficient manner."
About ZYESAMI™
ZYESAMI™ (aviptadil) is a synthetic
form of Vasoactive Intestinal Polypeptide (VIP) first discovered by
the late Prof. Sami Said in 1970,
and ZYESAMI™ is named in his honor. Although primarily concentrated
in the lung, it was first purified from the intestinal tract. VIP
binds specifically to the alveolar type II cell (ATII) in the air
sac (alveolus) of the lung, where it has been shown have potent
anti-inflammatory/anti-cytokine activity in animal models of
respiratory distress, acute lung injury, and inflammation. VIP
stimulates ATII cells to make the surfactant that must coat the
lining of the lungs in order for them to exchange
oxygen with the blood. Loss of surfactant causes respiratory
failure and alveolar collapse, which are hallmarks of
COVID-19.
COVID-19-related respiratory failure is caused by selective
infection of the ATII cell by the SARS-CoV-2 virus. The ATII cells
are vulnerable because of their (ACE2) surface receptors, which
serve as the route of entry for the virus. Coronavirus infection of
the ATII cell shuts down surfactant production, triggers the
formation of inflammatory cytokines, and causes cell death
(cytopathy). VIP is shown to upregulate surfactant production,
block Coronavirus replication in the ATII cell, block cytokine
synthesis, and prevent viral-induced cell death (cytopathy). Other
than ZYESAMI™, no currently proposed treatments for COVID-19
specifically target this mechanism of action.
About NRx
Pharmaceuticals
NRx Pharmaceuticals (Nasdaq:NRXP)
draws upon more than 300 years of
collective, scientific and drug-development experience to
bring improved health to patients. Its investigational product,
ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted
Fast Track designation by the US Food and Drug Administration (FDA)
and is currently undergoing phase 3 trials funded by the US
National Institutes of Health, the Biomedical Advanced Research and
Development Authority part of the US Department of Health and Human
Services, and the Medical Countermeasures program, part of the US
Department of Defense. The FDA has additionally granted
Breakthrough Therapy Designation, a Special Protocol Agreement, and
a Biomarker Letter of Support to NRx for NRX-101, an
investigational medicine to treat suicidal bipolar depression.
NRX-101 is currently in Phase 3 trials, with readouts expected in
2022. In July 2021, NRx was
awarded an exclusive worldwide license to develop and commercialize
the BriLife (VSV-ΔG) COVID-19 vaccine developed by the Israel
Institute of Biological Research.
NRx is led by executives who have held senior roles at Allergan,
J&J, Lilly, Novartis, Pfizer, and the US FDA. NRx is chaired
by Prof Jonathan Javitt, MD, MPH, who has held leadership
roles in six biotechnology startup companies with public exits and
been appointed to advisory roles in four US Presidential
administrations. The NRx board includes Dr. Sherry Glied,
former US Assistant Secretary for Health (ASPE), Daniel E. Troy, JD, former Chief Counsel of the
US FDA, Chaim Hurvitz, former director of Teva and President
of the Teva International Group, and General H.R. McMaster,
Ph.D. (US Army, Ret.) the 26th United States National
Security Advisor.
About Cardinal Health
Cardinal Health is a
distributor of pharmaceuticals, a global manufacturer and
distributor of medical and laboratory products, and a provider of
performance and data solutions for health care facilities. With 50
years in business, operations in more than 35 countries and
approximately 44,000 employees globally, Cardinal Health is
essential to care. Information about Cardinal Health is available
at cardinalhealth.com.
Cautionary Note Regarding Forward-Looking
Statements
This announcement of NRx Pharmaceuticals, Inc. includes
"forward-looking statements" within the meaning of the "safe
harbor" provisions of the U.S. Private Securities Litigation Reform
Act of 1995, which may include, but are not limited to, statements
regarding our financial outlook, product development, business
prospects, and market and industry trends and conditions, as well
as the company's strategies, plans, objectives, and goals. These
forward-looking statements are based on current beliefs,
expectations, estimates, forecasts, and projections of, as well as
assumptions made by, and information currently available to, the
company's management.
The company assumes no obligation to revise any forward-looking
statement, whether as a result of new information, future events or
otherwise. Accordingly, you should not place reliance on any
forward-looking statement, and all forward-looking statements are
herein qualified by reference to the cautionary statements set
forth above.
CORPORATE
CONTACT
|
INVESTOR
RELATIONS
|
|
|
Jack
Hirschfield
|
John
Mullay
|
Head of External
Affairs, NRx
|
Lifesci
Advisors
|
jhirschfield@nrxpharma.com
|
jmllaly@lifescienceadvisors.com
|
512-674-5163
|
617-429-3548
|
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SOURCE NRx Pharmaceuticals