Roche and Regeneron aim to be able to make two million doses of the antibody cocktail next year, but are awaiting clearance from regulators.
Roche Holding AG has completed early tests of its ability to produce large quantities of Regeneron Pharmaceuticals Inc’s COVID-19 antibody treatment, putting it on track to begin manufacturing the drug once it is authorised by regulators, Regeneron’s president said on Tuesday.
The experimental therapy was used to treat United States President Donald Trump in October. The companies aim to be able to make two million doses of the antibody cocktail next year, but are awaiting clearance from regulators.
Roche “has already started engineering runs at scale and [has] been successful,” Regeneron President and Chief Scientific Officer George Yancopoulos said in an interview ahead of this week’s Reuters news agency Total Health conference.
A Roche spokesman said the Swiss drugmaker would be ready to begin producing the treatment in the first quarter of 2021.
Regeneron has had discussions with the US Food and Drug Administration almost every day since it submitted its application for emergency use of the COVID-19 drug in October, and expects a final decision in the “very near future,” said Yancopoulos, a co-founder of the US biotech company.
Regeneron hopes to apply for full approval of the drug shortly afterwards, he said, echoing his comment during Regeneron’s investor call earlier this month.
The company has a contract to provide 300,000 doses of the antibody therapy, called REGN-COV2, to the US government and expects to be able to meet that commitment by as early as January. It has more than 50,000 doses currently stockpiled.
The two million doses Regeneron expects to be able to produce in partnership with Roche next year may not be enough to treat all the patients worldwide who could benefit from it, Yancopoulos said, based on the rate at which the coronavirus is again spreading and sickening people globally.
He added that Regeneron is in talks with US officials about providing more doses than it has already agreed to, but has not reached any conclusive agreement. Regeneron’s current contract with the US government priced 300,000 doses at $450m.
Regeneron has been speaking regularly with US President-elect Joe Biden’s COVID-19 task force and has shown its members a presentation on the antibody treatment, Yancopoulos said.
After Trump received the Regeneron treatment along with several other medicines during his bout with COVID-19, he touted it as a virtual “cure” for the illness, promising to make it free for Americans.