- New agreement covers 1.25 million additional doses of the antibody cocktail, bringing the total potential US supply to over 1.5 million doses
- Casirivimab and imdevimab were granted U.S. FDA Emergency Use Authorization for recently-diagnosed, high-risk, mild to moderate COVID-19 patients
- Roche and Regeneron are collaborating on developing and manufacturing casirivimab and imdevimab; Regeneron is distributing the antibody cocktail in the US and Roche will be responsible for distribution outside the US
Basel, 12 January 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today confirmed that the U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD) will purchase additional supply of Regeneron’s casirivimab and imdevimab antibody cocktail for use in non-hospitalised COVID-19 patients as part of Operation Warp Speed. The US government said it will provide these additional doses at no cost to patients, though healthcare facilities may charge fees related to administration, and will continue to coordinate allocation of the antibody cocktail to state and territorial health departments.
Under the new agreement, the US government will purchase up to 1.25 million finished doses of casirivimab and imdevimab by 30 June 2021. Regeneron is already supplying doses to treat approximately 300,000 people, bringing the total potential purchase to over 1.5 million doses in the US.
“We are doing all we can to lessen the impact of the ongoing COVID-19 pandemic, and we remain committed to collaborating with Regeneron to increase supply of their antibody cocktail,” said Bill Anderson, Chief Executive Officer of Roche Pharmaceuticals. “Casirivimab and imdevimab will be critically important to help address the pandemic if approved, and we will continue to work with regulators and governments across the globe to bring the medicine to as many people as possible.”
The efficacy and safety of casirivimab and imdevimab continue to be evaluated in clinical trials for the treatment of COVID-19 in certain hospitalised and non-hospitalised patients, including the open-label RECOVERY trial of hospitalised patients in the UK, and a trial for the prevention of COVID-19 in household contacts of infected individuals. Lower doses of casirivimab and imdevimab are also being studied with the aim of increasing supply and offering the therapy to more patients. To date, nearly 15,000 people have participated in casirivimab and imdevimab clinical trials.
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 actively 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 around the globe if approved and will support access in low- and lower-middle-income countries through drug donations to be made in partnership with public health organisations.