Regeneron Pharmaceuticals has received a $450 million contract from the federal government to manufacture and supply REGN-COV2, its investigational treatment of COVID-19.
The double antibody cocktail is currently in two phase 2/3 clinical trials and in a phase three trial for the prevention of COVID-19 infection.
According to a July 7 statement by the U.S. Department of Health and Human Services and the Department of Defense, the federal government will own the doses made available through this contract.
The ongoing REGN-COV2 clinical program is evaluating multiple dosages and will help establish the exact number of potential treatment doses ”“ estimated range of 70,000 to 300,000 ”“ or prevention doses ”“ estimated range of 420,000 to 1,300,000 ”“ available, according to Regeneron.
Initial doses are expected to be ready by the end of summer.
If the U.S. Food and Drug Administration grants emergency use authorization or in fact approves Regeneron”™s treatment, the federal government would allocate those doses to treat COVID-19 patients, according to a statement.
According to the HHS, as part of this contract, the doses of the medicine will be packaged and ready to ship immediately if clinical trials are successful and the FDA grants the emergency status or approves the medicine. The medicine would then be available to Americans at no cost, however, as is customary with such government-purchased products, health care professionals could charge insurers for the cost of administering the medicine.
“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.
Operation Warp Speed seeks to deliver 300 million doses of a “safe, effective vaccine for COVID-19 by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (collectively known as countermeasures).”
Regeneron at its own risk began increasing manufacturing of REGN-COV2 in the spring.
“Regeneron”™s thirty years of investment in our innovative VelociSuite antibody discovery and development technologies and our large-scale manufacturing facilities, coupled with the expertise and passion of our people, has enabled us to move the REGN-COV2 program forward at remarkable speed, said Leonard S. Schleifer, co-founder, president and CEO of the Tarrytown company.
Regeneron said it had used the same “rapid response” capabilities and cocktail approach to develop REGN-EB3, a novel triple antibody treatment for Ebola that is now under regulatory review by the FDA.
