Regeneron Pharmaceuticals, Inc. on January 12 announced that the U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD) will purchase additional supplies of the casirivimab and imdevimab antibody cocktail for use in non-hospitalized COVID-19 patients to meet the federal government's Operation Warp Speed goals. The government has said it will provide these doses at no cost to patients, though healthcare facilities may charge fees related to administration.
The development and manufacturing of the antibody cocktail has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of HHS, Office of the Assistant Secretary for Preparedness and Response.
Under the new agreement, the government will purchase all finished doses of the casirivimab and imdevimab antibody cocktail delivered by June 30, 2021, up to 1.25 million doses. Under a previous agreement, Regeneron is already supplying doses to treat approximately 300,000 people, bringing the total potential purchase to more than 1.5 million doses.
"COVID-19 continues to sicken hundreds of thousands of Americans every day and the people of Regeneron are committed to help," said Leonard S. Schleifer, MD, PhD, President and Chief Executive Officer of Regeneron. "Tackling the COVID-19 pandemic will require a combination of public health measures, vaccines and therapeutics. We are pleased to work with the U.S. government to supply our antibody cocktail as an important weapon in this fight."
The U.S. government has said it will continue to coordinate allocation of the antibody cocktail to state and territorial health departments. Patients, caregivers and healthcare providers can find sites with COVID-19 antibody treatments through these links to the HHS or National Infusion Center Association locator tools.
"Patients in our antibody cocktail outpatient clinical trial experienced significant reductions in virus levels and required fewer medical visits for COVID-19, suggesting the therapy can help reduce the current burden on hospitals and healthcare systems," said George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer of Regeneron. "Additionally, as expected, the virus continues to mutate, with the possibility of developing resistance to any one antibody. The Regeneron cocktail of two antibodies, each targeting a different site on the virus, reduces the possibility of the virus becoming resistant."
The casirivimab and imdevimab antibody cocktail continues to be evaluated in clinical trials for the treatment of COVID-19 in certain hospitalized and non-hospitalized patients, including the open-label RECOVERY trial of hospitalized patients in the UK, and a trial for the prevention of COVID-19 in household contacts of infected individuals. To date, nearly 15,000 people have participated in casirivimab and imdevimab clinical trials.
Details of the New Agreement
The current authorized dose for emergency use in non-hospitalized patients is 2,400 mg (1,200 mg casirivimab and 1,200 mg imdevimab) administered as a one-time infusion. Regeneron is evaluating the safety and efficacy of a lower 1,200 mg dose (600 mg casirivimab and 600 mg imdevimab) of the antibody cocktail in this 'outpatient' setting.
Under the agreement, the government will acquire doses at the lowest authorized dose. The government is obligated to purchase all finished doses supplied by June 30, up to 1.25 million doses total (an agreement value of up to $2.625 billion), and may accept doses after this date at its discretion. A number of factors may impact available finished supply by June 30, including manufacturing considerations and authorized dose levels. Regeneron expects to supply approximately 750,000 finished doses by the end of June based on the 2,400 mg dose level, with the vast majority supplied in the second quarter. Regeneron expects to fulfill the entire 1.25 million targeted doses if the 1,200 mg dose is authorized.