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UPDATE 2-U.S. expects over 1 mln COVID-19 antibody doses from Regeneron, Lilly in 2020

Fri, 09th Oct 2020 17:42

(Adds background on treatments)

By Michael Erman and Manas Mishra

NEW YORK, Oct 9 (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)

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