$326 Million Funds New COVID-19 Monoclonal Antibody

Regeneron Pharmaceuticals, Inc. today announced that the U.S. Biomedical Advanced Research and Development Authority (BARDA) entered into an agreement with the Company to support the clinical development, clinical manufacturing, and regulatory licensure process of a next-generation COVID-19 monoclonal antibody (mAb) therapy for the prevention of SARS-CoV-2 infections, which cause COVID-19 in people.

The agreement is part of the U.S. Department of Health and Human Services (HHS) 'Project NextGen' initiative to advance innovative vaccines and therapeutics for COVID-19.

Regeneron's most advanced next-generation antibody candidate under this agreement is expected to enter clinical trials in 2023.

For the new COVID-19 program announced on August 22, 2023, HHS will fund up to 70% of Regeneron's costs for certain clinical development activities for a next-generation mAb therapy. 

The new BARDA contract has an estimated value of up to approximately $326 million of government funding.

Regeneron's first COVID-19 mAb cocktail, REGEN-COV, was granted Emergency Use Authorization in November 2020, with nearly 3 million doses delivered to the U.S. Government between 2020 and 2022.

"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, in a press release.

"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."

Previously, the U.S. CDC wrote some immunocompromised people benefit from mAb therapy instead of COVID-19 vaccination.

Under the NextGen project structure, Regeneron independently invents and proposes an antibody candidate, which BARDA and Regeneron will evaluate and agree upon for further development, manufacturing, and regulatory activities.

BARDA and Regeneron have previously worked together to deliver novel medicines for Ebola.

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 ten pathogens that pose significant risks to public health.