Under the new agreement, Regeneron will supply an additional 1.4 million 1,200 mg doses of REGEN-COV to the U.S. government by January 31, 2022, at a cost of $2,100 per dose. This new agreement follows two earlier agreements with the U.S. government announced in July 2020 and January 2021.
REGEN-COV is an investigational medicine authorized by the U.S. FDA under an emergency use authorization to treat people who are at high risk of serious consequences from COVID-19 infection who are either already infected (non-hospitalized) or in certain post-exposure prophylaxis settings.
The REGEN-COV development program has reported positive Phase 3 results across the spectrum of COVID-19 infection, from prevention to hospitalization:
Prevention of symptomatic infection in asymptomatic household contacts (both uninfected and infected) of SARS-CoV-2 infected individuals
Treatment of non-hospitalized patients already infected with SARS-CoV-2
Treatment of certain patients hospitalized due to COVID-19 infection, including the UK RECOVERY trial
The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS's Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.
Regeneron invented REGEN-COV and is collaborating with Roche to increase global supply, with Roche primarily responsible for development and distribution outside the U.S.
Details of the Agreement
Regeneron expects to begin delivering the additional REGEN-COV doses to the U.S. government in September, with the vast majority delivered in 4Q21. Regeneron will record all net sales associated with this agreement. Pursuant to a prior agreement, Roche will manufacture approximately one third of the doses for Regeneron to fulfill this new agreement with the U.S. government.
About the REGEN-COV Antibody Cocktail
REGEN-COV (casirivimab and imdevimab) is a cocktail of two monoclonal antibodies that was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19, using Regeneron's VelocImmune and VelociSuite technologies. The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Cell and Science.
See also: U.S. Govt. Purchases Additional Doses of Lilly's Antibody Therapies for COVID