By Carl O’Donnell and Axel Threlfall

(Reuters) – Roche Holding AG has accomplished early assessments of its capacity to supply giant portions of Regeneron Prescription drugs Inc’s COVID-19 antibody therapy, placing it on monitor to start manufacturing the drug as soon as it’s approved by regulators, Regeneron’s president mentioned on Tuesday.

The experimental remedy was used to deal with U.S. President Donald Trump in October. The businesses purpose to have the ability to make 2 million doses of the antibody cocktail subsequent 12 months, however are awaiting clearance from regulators.

Roche “has already began engineering runs at scale and (has) been profitable,” Regeneron President and Chief Scientific Officer George Yancopoulos mentioned in an interview forward of this week’s Reuters Complete Well being convention.

A Roche spokesman mentioned the Swiss drugmaker could be prepared to start producing the therapy within the first quarter of 2021.

Regeneron has had discussions with the U.S. Meals and Drug Administration virtually day-after-day because it submitted its software for emergency use of the COVID-19 drug in October, and expects a closing choice within the “very close to future,” Yancopoulos, a co-founder of the U.S. biotech firm mentioned.

Regeneron hopes to use for full approval of the drug shortly afterwards, he mentioned, echoing his remark throughout Regeneron’s investor name earlier this month.

The corporate has a contract to offer 300,000 doses of the antibody remedy, known as REGN-COV2, to the U.S. authorities and expects to have the ability to meet that dedication by as early as January. It has greater than 50,000 doses at present stockpiled.

The two million doses Regeneron expects to have the ability to produce in partnership with Roche subsequent 12 months is probably not sufficient to deal with all of the sufferers worldwide who may gain advantage from it, Yancopoulos mentioned, primarily based on the speed at which the virus is once more spreading and sickening folks globally.

He added that Regeneron is in talks with U.S. officers about offering extra doses than it has already agreed to, however has not reached any conclusive settlement. Regeneron’s present contract with the U.S. authorities priced 300,000 doses at $450 million.

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Regeneron has been talking repeatedly with U.S. President-elect Joe Biden’s COVID-19 process drive and has proven them a presentation on the antibody therapy, Yancopoulos mentioned.

After Trump obtained the Regeneron therapy together with a number of different medicines throughout his bout with COVID-19, he touted it as a digital “treatment” for the sickness, promising to make it free for People.

For extra on Reuters Occasions Complete Well being click on right here: https://reutersevents.com/occasions/healthcare/.

(Reporting by Carl O’Donnell in New York and Axel Threlfall in London; Further reporting by John Miller in Zurich; Modifying by Invoice Berkrot)