Roche and Regeneron want to be able to manufacture two million doses of the antibody cocktail in the next year, but are waiting for approval by the regulatory authorities.
Roche Holding AG completed early tests of its ability to manufacture large quantities of Regeneron Pharmaceuticals Inc.’s COVID-19 antibody treatment. With that, she is on track to start manufacturing the drug as soon as it is approved by regulators, Regeneron’s president said Tuesday.
Experimental therapy was used to treat United States President Donald Trump in October. The companies want to be able to manufacture two million doses of the antibody cocktail in the next year, but are waiting for approval by the regulatory authorities.
Roche ”has already started large-scale engineering runs [has] was successful, ”said George Yancopoulos, President and Chief Scientific Officer of Regeneron, in an interview prior to this week’s conference with Reuters news agency Total Health.
A Roche spokesman said the Swiss drug maker is ready to start treatment in the first quarter of 2021.
Regeneron has had almost daily discussions with the US Food and Drug Administration since filing its emergency use application 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 thereafter, he said, reiterating his comment during Regeneron’s investor call earlier this month.
The company has signed a contract to supply the US government with 300,000 doses of REGN-COV2 antibody therapy and expects to meet this commitment by January. There are currently more than 50,000 cans in stock.
The two million doses Regeneron is projected to produce in partnership with Roche over the next year may not be enough to treat all of the patients worldwide who could benefit, Yancopoulos said, based on the rate at which the coronavirus is re-spreading and makes people sick globally.
He added that Regeneron is negotiating with US officials to provide more doses than previously agreed, but has not reached a final agreement. Regeneron’s current contract with the US government cost 300,000 cans at $ 450 million.
Regeneron has spoken regularly with US President-elect Joe Biden’s COVID-19 task force and given a presentation to its members on antibody treatment, Yancopoulos said.
After receiving Regeneron treatment along with several other drugs during his battle with COVID-19, Trump touted it as a virtual “cure” for the disease and promised to make it free for Americans.
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