Operation Warp Speed secures thousands of antibody doses, millions more likely needed

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Operation Warp Speed’s deal for Regeneron’s COVID-19 neutralizing antibody cocktail could provide the U.S. government enough doses to treat the expected number of hospitalized patients over the next year, but tens of millions more will likely be needed for less severe patients and for prophylaxis.

The $450 million contract, announced Tuesday, is Operation Warp Speed’s first investment in a COVID-19 therapeutic, and HHS Secretary Alex Azar suggested it won’t be the last.

“This agreement with Regeneron is the first of a number of Operation Warp Speed awards to support potential therapeutics all the way through to manufacturing, allowing faster distribution if trials are successful,” Azar said in a statement.

The Trump administration initiative has largely been focused on vaccines, and the Regeneron deal was one of two Warp Speed struck Tuesday, with the second a $1.6 billion contract for 100 million doses of a COVID-19 vaccine from Novavax Inc. (NASDAQ:NVAX). The funding for both deals come from the Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense (see "Novavax Gets Another Boost").

The antibody deal comes after Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) reported positive safety readouts from the Phase I portions of two adaptive clinical trials of its two-mAb combo, REGN-COV2, on Monday. The biotech also paired up with NIAID to launch a Phase III trial of the antiviral mAb cocktail as post-exposure prophylaxis (see “Four Late-Stage Protocols Harmonized”).

The funds will support continued manufacturing of REGN-COV2 while trials advance so the therapy can be immediately available in the U.S. if FDA grants Emergency Use Authorization (EUA) (see “Action Needed to Prevent Manufacturing Bottlenecks”).

“Working in parallel this way shaves months off the traditional product development timeline,” according to HHS.

Regeneron will receive $450 million and supply the U.S. with a fixed number of bulk lots this fall. The exact number of doses is not set as the biotech is still evaluating multiple doses in the clinic.

If used as a treatment, the number of secured doses would range from 70,000-300,000. If used as prophylaxis, the supply could stretch to 420,000-1.3 million doses.

Tuesday’s deal follows a report released last month by the Duke-Margolis Center for Health Policy that suggest that the U.S. government could step in to coordinate and facilitate COVID-19 therapeutics manufacturing to overcome the manufacturing bottleneck.

Assuming one dose per patient, Duke-Margolis estimated that over the next year, hospitalized patients would require 260,000 doses; non-hospitalized symptomatic patients would need 4.8 million doses; and people with close exposure to confirmed cases would need 20 million doses.

Using mAbs as prophylaxis for frontline healthcare workers would further drive up demand. Adam Kroetsch, research director of biomedical innovation and regulatory policy at Duke-Margolis, estimated that 13.8 million healthcare workers may require monthly doses for half a year, which would come out to more than 80 million antibody doses.

In 2019, companies sold a total of 53 million doses of mAbs across all diseases in the U.S., according to the Duke-Margolis report.

Regeneron gained $13.63 to $640.88 Tuesday.

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