HHS, DoD partner with Regeneron for large-scale manufacturing demonstration of potential COVID-19 treatment

Pressing forward with a potential antibody treatment for COVID-19 known as REGN-COV2, the U.S. Departments of Health and Human Services (HHS) and Defense (DoD) announced an agreement with Regeneron, Inc. this week that will culminate in a commercial-scale manufacturing demonstration.

REGN-COV2 is an investigational antiviral antibody treatment. Current clinical studies are assessing its capabilities at multiple dosage levels, to evaluate which treatment dose will be most effective. While the Food and Drug Administration (FDA) has yet to provide the treatment an emergency use authorization, Regeneron believes this project could yield between 70,000 and 300,000 doses, the first of which could be ready as early as this summer’s end.

“This agreement with Regeneron is the first of a number of Operation Warp Speed awards to support potential therapeutics all the way through to manufacturing, allowing faster distribution if trials are successful,” HHS Secretary Alex Azar said.

If successful, any doses produced from the demo will be owned by the federal government, which could then allocate those doses to treat patients. Some $450 million has been issued to Regeneron for that demonstration. As part of it, doses of the medicine will be packaged for immediate shipping, supposing the FDA grants an EUA or approves the medicine outright. Regeneron has reiterated that no further cost would be put on American recipients. Still, healthcare professionals could charge insurers for costs associated with administering the treatment.

The demonstration will take place simultaneously with the ongoing clinical trials. It is a move supported by the Trump administration’s Operation Warp Speed, which has pushed for companies to hasten medicine development for COVID-19.