Like many of its peers, Regeneron responded swiftly to the COVID-19 pandemic and moved treatment candidates quickly through testing. Now that its antibody cocktail has shown promise—and as the raging pandemic hits new heights in the U.S.—the company is amping up its efforts to manufacture hundreds of thousands of doses.
As Regeneron awaits word from the FDA on its therapeutic, the company is producing hundreds of thousands of doses by January under a supply deal with the U.S. government. The company expects to have 2.4 gram doses ready for about 80,000 patients by the end of November, and 200,000 doses ready by the first week of January, chief scientific officer George Yancopoulos said on a conference call Thursday.
By the end of January, Regeneron anticipates it’ll have around 300,000 doses ready for use.
As the agency reviews the antibody cocktail data, COVID-19 is flaring up again across the U.S. and elsewhere. Thursday, the U.S. reported its highest single-day new case tally of more than 120,000.
Beyond its plans to produce 300,000 doses by the end of January, Regeneron has partnered with Roche to expand capacity further. The company expects “to be able to make substantially more next year than we were able to make this year,” CEO Leonard Schleifer said on Thursday’s call.
Regeneron will have a full year to manufacture doses in 2021, he pointed out, and will have more facilities that are “operational and dedicated” to producing the medicine. Meanwhile, Roche is “working very hard to bring online very enhanced and large manufacturing capacity,” Schleifer said.
Regeneron entered COVID-19 research early this year as the outbreak was in its early stages, testing hundreds of virus-neutralizing antibodies in mice and seeing how they compared with antibodies from human survivors of the novel coronavirus. In June, the company moved two antibodies that make up its cocktail into human testing and started prepping for larger-scale manufacturing. The company reported early results in September and sought an FDA emergency nod in October.
Along the way, the company’s Ebola antibody scored an FDA approval, which Yancopoulos said validates the company's infectious diseases approach.