Regeneron (REGN) Announces New U.S. Government Agreement to Purchase Additional Doses of REGEN-COV Antibody Cocktail

September 14, 2021 5:36 PM EDT

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New agreement for 1.4 million doses of REGEN-COV, brings total purchased by the U.S. government to nearly 3 million doses

REGEN-COV currently authorized to treat certain infected patients to reduce risk of hospitalization or death from COVID-19, and for post-exposure prophylaxis for close contacts of infected individuals

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD) will purchase 1.4 million additional doses of REGEN-COV (casirivimab and imdevimab). The government will continue to provide REGEN-COV at no cost to patients.

"More than a year and a half into this pandemic, too many people are still being hospitalized and dying due to COVID-19," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "While vaccination remains the first line of defense to decrease the burden of COVID-19, REGEN-COV is a key tool that reduces the risk of hospitalization or death by 70% in high-risk individuals when given early in the course of the infection. Recently there has been greater demand for REGEN-COV, and we will provide additional doses to the U.S. government as quickly as possible."

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. Food and Drug Administration (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.

In addition, the robust REGEN-COV development program has reported positive Phase 3 trial 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 AgreementRegeneron expects to begin delivering the additional REGEN-COV doses to the U.S. government in September, with the vast majority delivered in Q4 2021. 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.



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