U.S. Expects 1 Million Doses of Covid Antibody Before 2021 (1)

The U.S. has already secured hundreds of thousands of doses of experimental antibody treatments for Covid-19 in anticipation of regulators authorizing their emergency use, federal health officials said on Friday.

The government expects to have 1 million doses of the so-called monoclonal antibody treatments on hand before year-end.

The treatments have come into the spotlight after President Donald Trump received one such experimental therapy last week for his case of Covid-19.

Eli Lilly & Co. and Regeneron Pharmaceuticals Inc. this week asked the U.S. Food and Drug Administration for emergency-use authorizations for their antibody therapies but haven’t yet received clearance. Trump has since repeatedly promised to hasten their approval, widen access and provide them to Americans for free.

“We have engaged in a number of contracts for procurement of these monoclonal antibodies already,” said Paul Mango, deputy chief of staff for policy at the Department of Health and Human Services. The government is acquiring doses through its Strategic National Stockpile as they are manufactured, he said.

Read more: Trump hails antibody treatment

Mango spoke during a briefing on the latest developments of Operation Warp Speed, the White House-led effort to expedite the development, manufacturing and distribution of coronavirus vaccines and treatments.

Early data from Lilly’s single antibody and Regeneron’s antibody cocktail suggest both are effective in keeping people infected with the new coronavirus out of the hospital.

“The interest in the monoclonal antibodies is quite high,” said Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA. Woodcock, who is serving as a part of Operation Warp Speed, has recused herself from taking part in the approval decisions related to coronavirus therapeutics.

Biggest Challenge

Health-care experts and industry executives have said that manufacturing poses the most significant challenge in getting antibody treatments to all who may need it. The process is costly and demand is likely to outstrip supply.

Lilly said earlier this week it would have 100,000 doses of the single-antibody product its developing with Canadian biotech AbCellera Biologics Inc. available in October, and as many as 1 million doses available by year-end.

The Indianapolis-based pharmaceutical giant is also studying a cocktail of two antibodies, and expects to approach regulators for authorization in November and seek full approval in the second quarter of 2021. Supplies of the cocktail, which adds in a second antibody that Lilly licensed from Shanghai Junshi Biosciences Co., are much more limited, with only about 50,000 doses available this year.

Regeneron said Wednesday it has enough doses for about 50,000 patients and expects to have enough doses available for 300,000 patients in the next few months. Warp Speed officials said the distribution plan will be similar to remdesivir, with the federal government allocating to states with the highest need.

The greatest challenge ahead, Woodcock said, will be coordinating sites where patients can receive the antibody treatments, which must be administered intravenously by health-care professionals, unlike vaccines, which can be given from the more convenient confines of a pharmacy.

(Updates with details under the Biggest Challenge subheadline)

To contact the reporters on this story:
Riley Griffin in New York at rgriffin42@bloomberg.net;
Jeannie Baumann in Arlington at jbaumann27@bloomberg.net

To contact the editors responsible for this story:
Timothy Annett at tannett@bloomberg.net

Mark Schoifet

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