US Gov’t in $2.6-Bn Supply Deal for Regeneron’s COVID-19 Antibody CocktailBy
Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, has announced that the US government has agreed to purchase additional supply of its antibody cocktail (consisting of casirivimab and imdevimab) for treating non-hospitalized COVID-19 patients, in a deal worth up to $2.6 billion.
Under the new agreement, the US government will purchase all finished doses of the casirivimab and imdevimab antibody cocktail that are 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 over 1.5 million doses.
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, 2021 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, 2021, including manufacturing considerations and authorized dose levels. Regeneron expects to supply approximately 750,000 finished doses by the end of June 2021 based on the 2,400-mg dose level, with the vast majority supplied in the second quarter 2021. Regeneron expects to fulfill the entire 1.25 million targeted doses if the 1,200-mg dose is authorized.
The additional supply, purchased by the US Department of Health and Human Services (HHS) and the US Department of Defense, will be used to meet the US government’s goals for Operation Warp Speed, a US initiative to speed the development and distribution of COVID-19 vaccines and treatments. The US government has said it will continue to coordinate allocation of the antibody cocktail to state and territorial health departments.
Roche is collaborating with Regeneron to increase global supply of casirivimab and imdevimab, with the aim of having more than 2 million treatment doses available annually. Regeneron is responsible for the development and distribution of the treatment in the US, and Roche is primarily responsible for the development and distribution outside the US. Roche is working with governments outside of the US on potential supply agreements. The companies share a commitment to making the antibody cocktail available to COVID-19 patients globally if approved and will support access in low- and lower-middle-income countries through drug donations to be made in partnership with public health organizations.
In November 2020, the casirivimab and imdevimab antibody combination received emergency use authorization from the US Food and Drug Administration for treating mild-to-moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization
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 trial of hospitalized patients in the UK, and a trial for the prevention of COVID-19 in household contacts of infected individuals. To date (as reported on January 12, 2021), nearly 15,000 people have participated in casirivimab and imdevimab clinical trials.