July 7, 2020
HHS, DOD Collaborate with Regeneron on Large-Scale Manufacturing Demonstration Project of COVID-19 Investigational Therapeutic Treatment
The U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD) today announced an agreement with Regeneron, Inc. of Tarrytown, New York, to demonstrate commercial-scale manufacturing of the company’s COVID-19 investigational anti-viral antibody treatment, REGN-COV2. By funding this manufacturing effort, the federal government will own the doses expected to result from the demonstration project.
The ongoing REGN-COV2 clinical studies are evaluating multiple dosages to help establish the exact number of potential treatment doses. The company estimates between 70,000 and 300,000 treatment doses could be available from this project, with the initial doses ready as early as end of summer and completed this fall. If the U.S. Food and Drug Administration (FDA) grants Emergency Use Authorization (EUA) or approves the treatment, the federal government would allocate these doses to treat COVID-19 patients.
“This agreement with Regeneron is the first of a number of Operation Warp Speed awards to support potential therapeutics all the way through to manufacturing, allowing faster distribution if trials are successful,” said HHS Secretary Alex Azar. “More good news about COVID-19 therapeutics is constantly emerging, and President Trump’s commitment to supporting lifesaving therapeutics will help deliver these products to American patients without a day’s delay.”
This manufacturing demonstration project will take place while clinical trials are underway. Working in parallel this way shaves months off the traditional product development timeline and supports the Trump Administration’s Operation Warp Speed goal of making safe and effective medicine available as quickly as possible to save lives during the COVID-19 pandemic.
The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response, collaborated with the DoD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command, to provide $450 million to Regeneron for large-scale manufacturing demonstration project in the United States.
As part of the manufacturing demonstration project, the doses of the medicine will be packaged and ready to ship immediately if clinical trials are successful and FDA grants an EUA or approves the medicine. If these government-funded doses become available under EUA or FDA approval, the medicine would be available to the American people at no cost and would be allocated similarly to drugs that other companies have donated during the pandemic response. As is customary with such government-purchased products, healthcare professionals could charge insurers for the cost of administering the medicine.
An EUA can be issued to facilitate the availability of an unapproved product only after several statutory requirements are met. For investigational treatments being developed to treat or prevent COVID-19, FDA will make an assessment on a case-by-case basis depending on the product’s characteristics, preclinical and human clinical study data, and the totality of relevant available scientific evidence. The issuance of an EUA is different than FDA approval.
The REGN-COV2 investigational antibody therapeutic treatment was discovered and developed by Regeneron using the company’s VelociSuite technologies. The medicine combines two monoclonal antibodies, informally known as an antibody cocktail, that bind to the spike protein of the SARS-CoV-2 virus and may be able to treat infected patients or prevent infection.
Monoclonal antibodies are produced outside of the body by a single clone of cells or a cell line with identical antibody molecules and then delivered to patients by injection or infusion. The antibodies bind to certain proteins of a virus, reducing the ability of the virus to infect human cells.
Preclinical and clinical development for this therapeutic treatment have been supported in part through a long-standing flexible agreement between BARDA and Regeneron. Regeneron used the same proprietary technology platforms and cocktail approach to develop a novel triple antibody treatment for Ebola that is now under regulatory review by the FDA.
About HHS, ASPR, and BARDA:
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, 55 BARDA-supported products have achieved FDA approval, licensure or clearance. For more on BARDA’s portfolio for COVID-19 diagnostics, vaccines and treatments and about partnering with BARDA, visit medicalcountermeasures.gov. To learn more about federal support for the all-of-America COVID-19 response, visit coronavirus.gov.
About the JPEO-CBRND:
The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) protects the Joint Force by providing medical countermeasures and defense equipment against chemical, biological, radiological and nuclear threats. As an effective DoD acquisition program, the JPEO-CBRND’s vision is a resilient Joint Force enabled to fight and win unencumbered by a CBRN environment; championed by innovative, agile, results-oriented acquisition professionals. The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) facilitates the advanced development and acquisition of medical solutions to combat CBRN and emerging threats. JPM CBRN Medical works with JPEO-CBRND’s Joint Project Lead for Chemical, Biological, Radiological and Nuclear Defense - Enabling Biotechnologies to provide new and improved medical countermeasures to enable a single treatment for many threats, rapid medical countermeasure responses, genomic sequencing and the capability to diagnose CBRN threats before the onset of symptoms. To learn more about JPEO-CBRND’s COVID-19 response, visit https://www.jpeocbrnd.osd.mil/coronavirus.