Regeneron Announces Agreement with BARDA Supporting Development of Next-Generation Antibody Therapy for COVID-19 Prevention
Thursday, August 24, 2023
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the Biomedical Advanced Research and Development Authority (BARDA) has entered into an agreement with Regeneron to support clinical development, clinical manufacturing and the regulatory licensure process of a next-generation COVID-19 monoclonal antibody therapy for the prevention of SARS-CoV-2 infection. The agreement is part of ‘Project NextGen,’ an initiative by the U.S. Department of Health and Human Services (HHS) to advance a pipeline of new, innovative vaccines and therapeutics for COVID-19.
BARDA, part of the Administration for Strategic Preparedness and Response at HHS, and Regeneron have previously worked together to deliver novel medicines for Ebola and COVID-19 at unprecedented speed and under urgent circumstances. The new program announced today falls under Regeneron and BARDA’s ongoing Other Transactions Agreement initiated in 2017 to develop a portfolio of antibodies targeting up to 10 pathogens that pose significant risk to public health. For the new COVID-19 program, HHS will fund up to 70 percent of Regeneron’s costs for certain clinical development activities for a next-generation monoclonal antibody therapy with broad neutralizing activity against SARS-CoV-2, the virus that causes COVID-19. The new contract has an estimated value of up to approximately $326 million of government funding.
“We’re pleased to expand our longstanding BARDA relationship, which is predicated on Regeneron’s decades of investment in deep scientific research and enabling technologies,” said Leonard S. Schleifer, M.D., Ph.D., Board Co-Chair, President and Chief Executive Officer of Regeneron. “Although COVID-19 has moved to an endemic stage, many people – including those with immunocompromising conditions – continue to face exposure that impacts their everyday life and could cause serious health consequences. We believe Regeneron can once again apply our drug discovery and development expertise to help prevent disease in vulnerable populations. American biopharmaceutical companies developed remarkable COVID-19 therapeutics and vaccines in record time, successfully changing the course of the pandemic, and we’re gratified that the U.S. Government continues to support early research from this uniquely innovative industry.”
Under the project structure, Regeneron independently invents and proposes an antibody candidate, which BARDA and Regeneron will then evaluate and agree upon for further development, manufacturing and regulatory activities. Regeneron’s most advanced next-generation antibody candidate under this agreement is expected to enter clinical trials later this year.
Starting in early 2020, Regeneron scientists rapidly responded to the COVID-19 pandemic by discovering and manufacturing a highly potent, anti-spike antibody cocktail that successfully neutralized many SARS-CoV-2 variants, including Delta. Developed at record speed and first granted Emergency Use Authorization in November 2020, the antibody cocktail was used as a COVID-19 treatment and preventative for millions of people around the globe, with nearly 3 million doses delivered to the U.S. Government between 2020 and 2022.
The next-generation antibody project is being funded in part with federal funds from BARDA under OT number: HHSO100201700020C.
About Regeneron
Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led for 35 years by physician-scientists, Regeneron’s unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in Regeneron's laboratories. Regeneron's medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases, and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
For additional information about Regeneron, please visit www.regeneron.com or follow Regeneron on LinkedIn.
