Regeneron Announces Additional U.S. Government Purchase of 1.4 Million Doses of REGEN-COV™ Antibody Cocktail

Compiled and Translated by | Tom Li

Recently, Regeneron announced that the U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD) will purchase an additional 1.4 million doses of the REGEN-COV antibody cocktail therapy (casirivimab and imdevimab) for the treatment and prevention of COVID-19, at a total procurement value of up to $2.94 billion.

Under the newly reached procurement agreement, Regeneron will supply the U.S. government with an additional 1.4 million doses of 1,200-mg REGEN-COV at a purchase price of $2,100 per dose (approximately RMB 13,000), with a delivery deadline of January 31, 2022. Previously, the U.S. government had already entered into two separate procurement agreements with Regeneron in July 2020 and January 2021. Combined with a prior agreement for 1.6 million doses of the COVID-19 therapeutic REGEN-COV, the U.S. government's total procurement of the company's COVID-19 antibody therapy has reached 3 million doses.

REGEN-COV consists of the monoclonal antibodies casirivimab and imdevimab, which are laboratory-produced proteins designed to mimic the body's natural immune system and enable patients to combat harmful pathogens such as SARS-CoV-2 (the novel coronavirus). Notably, REGEN-COV is the only COVID-19 antibody therapy in the United States indicated for both treatment and post-exposure prophylaxis.

In response, Leonard S. Schleifer, M.D., President and Chief Executive Officer of Regeneron, stated, “The COVID-19 pandemic has lasted for more than a year and a half, yet too many people continue to be hospitalized and die from COVID-19. While vaccination remains the first line of defense in reducing the clinical burden of COVID-19, REGEN-COV is a critical treatment that, when administered to patients early in the course of infection, can reduce the risk of hospitalization or death by 70% in high-risk populations.”

In November 2020, REGEN-COV received an Emergency Use Authorization (EUA) from the FDA for the treatment of high-risk individuals recently diagnosed with mild-to-moderate COVID-19, including pediatric and adult patients aged 12 years and older weighing at least 40 kg who have tested positive for SARS-CoV-2 and are at high risk of progressing to severe COVID-19 and/or hospitalization. Subsequently, in July, the FDA revised the EUA for REGEN-COV to authorize its use for post-exposure prophylaxis of COVID-19 in emergency settings, applicable to high-risk adult and pediatric patients (aged 12 years and older weighing at least 40 kg) who are at risk of progressing to severe COVID-19 (including hospitalization or death). Additionally, REGEN-COV received the world's first regulatory approval in Japan for the treatment of patients with mild-to-moderate COVID-19 via intravenous infusion. Beyond Japan, REGEN-COV is currently authorized for emergency or temporary use in more than 20 countries worldwide.

Schleifer stated that clinical demand for REGEN-COV in the market is currently on an upward trend, and Regeneron will supply additional doses to the U.S. government. The company is currently collaborating with Roche to expand the global supply capacity for REGEN-COV, with Roche primarily responsible for the development and distribution of the drug in markets outside the United States.

Source: REGENERON ANNOUNCES NEW U.S. GOVERNMENT AGREEMENT TO PURCHASE ADDITIONAL DOSES OF REGEN-COV™ (CASIRIVIMAB AND IMDEVIMAB) ANTIBODY COCKTAIL