Tarrytown-based Regeneron reports that it anticipates recording approximately $260 million in sales of its antiviral monoclonal antibody cocktail REGEN-COV U.S. to the U.S. government for the first quarter of 2021.
Continuing deliveries of the drug to the government are scheduled for the second quarter and, according to the company, the government is obligated to buy all finished doses supplied by June 30, up to 1.25 million doses in all.
REGEN-COV is a cocktail of two monoclonal antibodies that was designed specifically to block the Covid-19 virus”™ spike proteins from binding to human cells. New data from ongoing clinical trials show that the cocktail reduced the risk of hospitalization or death by 70% or 71% depending upon the dose that was administered.
The cocktail is given to patients by intravenous infusion. Principal doses of the drug are 1,200 mg (milligrams) and 2,400 mg.
“With approximately 60,000 newly diagnosed individuals in the U.S. every day and 40,000 still in the hospital because of Covid-19, we are committed to working with the government, health care providers and others to support rapid and widespread adoption of REGEN-COV in appropriate patients,” said George D. Yancopoulos, president and chief scientific officer at Regeneron.
“We will discuss the new data with regulatory authorities and request that the 1,200 mg dose be rapidly added to the U.S. Emergency Use Authorization in order for the anticipated REGEN-COV supply to be available to treat even more patients.”
Suraj Saggar, an investigator in the trials, who is chief of infectious disease at Holy Name Medical Center in Teaneck, New Jersey, said, “With so many people still getting infected, as well as recent data showing that REGEN-COV addresses emerging variants, these data underscore the need to rapidly adopt REGEN-COV as standard-of-care to offer high-risk patients their best chance to reduce serious consequences like hospitalization or death.”
Data also show that the cocktail can be effective at reducing the amount of virus in a person even when it is administered at much lower doses. Also being studied is giving the drug to patients using subcutaneous administration where the needle is inserted under the patient”™s skin rather than into a vein.
Regeneron said that as of March more than 25,000 people have participated in its clinical trials of the cocktail and that detailed results of its studies will be shared with regulatory authorities and submitted for peer review as soon as possible.
