U.S. expects over 1 million COVID-19 antibody doses from Regeneron, Lilly in 2020

By Michael Erman and Manas Mishra

NEW YORK (Reuters) – The U.S. government expects to be able to provide at no cost more than 1 million doses of antibody treatments for COVID-19 similar to the one President Donald Trump received to treat his illness, according to a top U.S. health official on Friday.

The government’s Operation Warp Speed program currently has “a couple of hundred thousand doses” of the monoclonal antibody treatments being developed by drugmakers Regeneron Pharmaceutical Inc and Eli Lilly & Co , U.S. Department of Health and Human Services official Paul Mango said on a call with reporters. That would top 1 million doses by the end of the year, he said.

Trump received Regeneron’s treatment last week. In a radio interview with Rush Limbaugh on Friday, Trump said he is working to get both drugs approved quickly and that he may not have recovered without the treatments he received.

Both companies have said the drugs were shown to work in clinical trials and that they have submitted an emergency use authorization to the U.S. Food and Drug Administration (FDA).

The drugs are not identical: Regeneron’s treatment is a cocktail of two antibodies meant to protect against the virus, while Lilly’s is a single antibody. Because they have not been tested against the other, it is difficult to know if one is more effective than the other.

It is unclear how long the FDA process to authorize emergency use of the drugs will take. Unless the companies receive that authorization, doctors cannot administer the drugs to patients outside of clinical trials or without a compassionate use authorization like the one President Trump received.

If the drugs are authorized for use by the FDA, Mango said that the government will allocate the treatments to the states based on need, similar to the mechanism used with Gilead Sciences Inc’s antiviral drug remdesivir for COVID-19.

Regeneron signed a $450 million deal in July to sell Operation Warp Speed enough doses of its antibody treatment, REGN-COV2, to treat around 300,000 people.

The company said it has not signed any additional deals with Operation Warp Speed, and has around 50,000 doses of its treatment ready now.

Lilly said on Friday it has not signed an agreement with Operation Warp Speed. It said earlier this week that it expects to produce around one million doses of the treatment this year.

(Reporting by Manas Mishra in Bengalaru and Michael Erman in New York; writing by Caroline Humer; Editing by Chizu Nomiyama, Aurora Ellis and Kirsten Donovan)