- NRx Enters into Negotiations for Financing and Manufacturing Capacity with BNP Paribas to serve European and Adjacent Markets
- Tech Transfer and Scaleup of BriLife™ COVID-19 Vaccine to Commence in November 2021
- Targeting Initiation of GMP Vaccine Manufacture in First Half of 2022
RADNOR, Pa., Nov. 5, 2021 /PRNewswire/ — NRx Pharmaceuticals (NASDAQ: NRXP), via its subsidiary, NRx Luxembourg (NRx), has concluded a business mission to Luxembourg at the invitation of the Luxembourg Ministry of the Economy in preparation for the establishment of vaccine manufacturing capability to serve European and adjacent markets. NRx Luxembourg has been granted an operating company business license by the Luxembourg government and has established a commercial banking relationship with BNP Paribas (Luxembourg), managed by BNP’s Head of Global Trade Solutions. NRx is currently negotiating a comprehensive banking and finance solution in preparation for tech transfer, scale-up, and manufacture of the BriLife™ vaccine.
NRx has agreed to a tech transfer and scale-up contract with an advanced viral vector, contract research, and manufacturing organization in the Luxembourg region, with the objective to advance the BriLife vaccine from its current research scale platform to a scalable, adherent cell viral vector manufacturing platform that conforms to Good Manufacturing Practices (GMP) and other regulatory requirements.
NRx and BNP’s Head of Global Trade Solutions have met with Luxembourg’s Directorate of Research and Innovation of the Ministry of the Economy to begin framing a vaccine manufacturing structure with government support that is intended to have the capability of delivering in excess of 300 million doses per year of vaccine at initial scale.
“As we begin to understand the potential of the BriLife vaccine to resist the Delta variant and other emerging variants of concern, we are working to put in place the manufacturing backbone that will enable us to begin building a large scale capability to deliver the technology. BriLife is manufactured by a newly-developed bioreactor technology previously developed for gene therapy,” said Jonathan Javitt, MD, MPH, Chief Executive Officer and Chairman of the Board of NRx. “We are fortunate that Luxembourg has shown us a confluence of unique technological capability, an enthusiastic financing environment, and a set of government priorities that include the type of environmentally friendly, high technology, health-tec manufacturing we require to advance BriLife to the next level. Health-tec is an announced developmental priority of the Luxembourg government.”
NRx plans to finalize and initiate the next phase of its BriLife vaccine development program before the holiday season as the Company also finalizes the European sites for its planned phase 3 trial.
About NRx Pharmaceuticals
NRx Pharmaceuticals (NRx) 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, the Government of Israel awarded NRx the exclusive worldwide right to develop and market the BriLife™ COVID-19 vaccine developed by the Israel Institute for 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.
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 US 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.
Head of Corporate Communications, NRx
SOURCE NRx Pharmaceuticals