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- NRx Pharmaceuticals (Nasdaq:NRXP) to collaborate with Ministries of Health of Georgia, Hungary, and Ukraine to conduct phase III development of ZYESAM™ in coordination with the Senator Richard Lugar Research Institute
- Costs of approximately $60 million to be shared by NRx and Denk Pharma, Georgia. Cromos Pharma and Denk Pharma will jointly oversee clinical development and distribution
- NRx dedicated to development of innovative medicines and vaccines for life-threatening, unmet medical needs in its mission of "Bringing Hope to Life"
- NRx expects to receive Emergency Use Authorization for ZYESAMI™ (Aviptadil acetate) to treat critically-ill patients suffering respiratory failure in Covid-19 in the face of current pandemic conditions
RADNOR, Pa., May 26, 2021 /PRNewswire/ -- Today, NRx Pharmaceuticals, Inc., (Nasdaq:NRXP) (NRx) through its Georgia subsidiary, announced that it has signed a master services agreement with Cromos Pharma, LLC, headquartered in Longview, Washington, to conduct phase 3 clinical trials of COVID-19 related drugs and vaccines in Central Europe and the Caucasus Region. The Senator Richard Lugar Research Institute, a US Government-funded regional research laboratory also serves as part of the collaboration. This region comprises a population of more than 500 million people, many of whom lack access to current COVID-19 vaccines and therapies.
NRx Pharmaceuticals to Lead Development of COVID-19 Medicines and Vaccines in Central Europe and the Caucasus Region
"As a newly-listed Nasdaq company we are set to deliver on our plans to deliver lifesaving medicines and vaccines where none exist and fulfill our credo of "Bringing Hope to Life," said Prof. Jonathan Javitt, MD, MPH, CEO and, Chairman of the Board of NRx. "We are honored by the trust bestowed upon us by the governments and people of this region. We aim to complete our inhaled drug trial by September 2021 and to seek emergency use authorization for inhaled ZYESAMI™ from regional regulators.
NRx CEO and Chairman, Jonathan Javitt, MD, MPH met this month with the Prime Minister and Health Minister of Georgia and, with senior officials from the Ministry of Health of Ukraine to confirm final plans for the June 2, 2021 study initiation.
NRx's collaborative efforts for this initiative are led by NRx senior leaders Dr. Stephen Cunnion, MD (CAPT. MC, USN, Ret.), and Dr. Dennis McBride, PhD, (CAPT. MSC, USN, Ret., SE4 NDU, Ret.). Dr. Cunnion previously led the Defense and Intelligence communities' response to Coronavirus epidemics starting with the SARS and MERS epidemics. Dr. McBride is a former Professor of the National Defense University who previously led critical healthcare initiatives at the Potomac Institute and Defense Advanced Research Projects Agency (DARPA).
Cromos will support NRx in the development of ZYESAMI™ (Aviptadil acetate) for home treatment of COVID-19, working to reduce the incidence of hospitalization and death. In addition to the urgent human need, this initiative may reduce the current overwhelming demand for hospital resources. Cromos will further provide safety monitoring and pharmacovigilance for population-wide emergency use of intravenous ZYESAMI™ in critically-ill patients, upon approval by national ministries of health.
"The Georgia National Center for Disease Control (NCDC) and the Lugar Institute are committed to bringing the latest technology to fight the lethal effects of Coronavirus to the Caucasus Region and Central Europe. We look forward to working once again with our US colleagues in this critical initiative," said Dr. Amiran Gamkrelidze, MD Director of the NCDC and former Health Minister of Georgia.
About NRx Pharmaceuticals
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) is a patient-focused, clinical-stage pharmaceutical company, drawing upon more than 100 years of collective medicine development experience. NRx creates therapies to treat diseases where no medicines currently exist.
NRx expects to seek Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) to treat Critical Covid-19 in patients suffering respiratory failure in May 2021. In addition, the FDA recently granted Breakthrough Therapy Designation and a Special Protocol Agreement to develop NRX-101 in suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with data readouts expected in the first half of 2022.
Cautionary Note Regarding Forward-Looking Statements
This press release 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. Words such as "expect," "anticipate," "should," "believe," "hope," "target," "project," "goals," "estimate," "potential," "predict," "may," "will," "might," "could," "would," "seek," "plan," "intend," "shall," and variations of these terms or the negative of these terms and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are, by their nature, subject to significant risks and uncertainties, many of which involve factors or circumstances that are beyond the company's control. These risks and uncertainties include, but are not limited to, our relatively limited operating history; our ability to expand, retain and motivate our employees and manage our growth; risks associated with general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of the novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; changes in laws, rules or regulations relating to any aspect of the company's business operations, or general economic, market and business conditions; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Furthermore, there can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. The company assumes no obligation and does not intend to update or otherwise revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by applicable law. As a result of these and other risks, uncertainties and assumptions, forward-looking events and circumstances discussed herein might not occur in the way that the company's management expects, if at all. 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.
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NRx Pharmaceuticals, Inc.
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