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September 14 2021


Regeneron Announces New U.S. Government Agreement to Purchase Additional Doses of REGEN-COV™ (casirivimab and imdevimab) Antibody Cocktail
September 14 2021 - 05:33PM
PR Newswire (US)


TARRYTOWN, N.Y., Sept. 14, 2021 /PRNewswire/ --

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 Agreement
Regeneron 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.

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 proprietary 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.

Multiple analyses have shown that the antibody cocktail retains potency against the main variants of concern circulating within the U.S., including Delta (first identified in India), Gamma (first identified in Brazil), Beta (first identified in South Africa) and Mu (first identified in Colombia), with information available in the Fact Sheet for Healthcare Providers. Consequently, REGEN-COV remains available for use across the U.S., and Regeneron will continue actively monitoring the potency of REGEN-COV against emerging variants.

REGEN-COV has not been approved by the FDA, but is currently authorized for treatment and post-exposure prophylaxis in certain high risk individuals. Post-exposure prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19. REGEN-COV is not authorized for pre-exposure prophylaxis for prevention of COVID-19 or for use in patients who are hospitalized due to COVID-19 or require oxygen therapy, or for people currently using chronic oxygen therapy because of an underlying comorbidity who require an increase in baseline oxygen flow rate due to COVID-19. This authorization is for the duration of the declaration that circumstances exist justifying the authorization of the emergency uses under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Additional information about REGEN-COV in the U.S. is below (authorized uses and important safety information).

In August, Regeneron submitted the first of two Biologics License Applications (BLAs) for REGEN-COV. The initial submission included data on the efficacy and safety of REGEN-COV to treat and prevent SARS-CoV-2 infection in non-hospitalized people. The second BLA submission will focus on those hospitalized because of COVID-19, and is expected to be completed later this year.

Emergency or temporary pandemic use authorizations are currently in place in more than 35 countries, including the U.S., several European Union countries, India, Switzerland and Canada, and the antibody cocktail is fully approved in Japan.

Regeneron and Roche share a commitment to making the antibody cocktail available to COVID-19 patients around the globe and will support access in low- and lower-middle-income countries through drug donations to be made in partnership with public health organizations.

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Earlier this week, the White House and Department of Health and Human Services (HHS) announced plans to control the U.S. monoclonal antibody supply due to distribution issues.

Before the change, states and hospitals could purchase the antibodies on their own without going through the federal government