EAST GREENBUSH — Pharmaceutical researcher/manufacturer Regeneron has landed a $450 million federal contract to produce to a COVID-19 treatment.
It is not a vaccine but a mixture of antibodies that could help keep infected patients from getting sicker and help keep healthy people from getting infected.
The biotechnology company is headquartered in Westchester County and has a large and growing production facility in East Greenbush. The new antiviral cocktail, dubbed REGN-COV2, is being produced there.
Regeneron announced the contact Tuesday. It is part of Operation Warp Speed, the public-private partnership created by the federal government in response to the pandemic.
Vaccines, which prompt the body to fight an infection in the future, also are being researched as part of Warp Speed. Regeneron’s antibody cocktail is a more acute treatment.
The body’s immune system produces antibodies as a response to infection. They latch onto the spike protein of a virus, blocking the virus from entering a cell unless it mutates.
REGN-COV2 is a combination of one human antibody and one mouse antibody that have each proved particularly robust against the COVID-19 virus. The virus would have to mutate in two directions at once to defeat it.
It is currently in the second of three phases of clinical trials for treatment of infection and the third phase of a trial for infection prevention.
Initial doses may be ready for the public as early as the end of summer.
One goal of the trials is to determine how big the doses need to be. The batch to be produced could yield 70,000 to 300,000 potential treatment doses or 420,000 to 1.3 million prevention doses.
As the pandemic accelerated in the United States this spring, Regeneron increased production volume of REGN-COV2 without a contract or regulatory approval, taking a risk that the product would be approved and still needed when it was ready to go to market.
The $450 million contract announced Tuesday supports continued manufacturing so that the antibody cocktail will be available immediately if the clinical trials are successful and if the U.S. Food and Drug Administration grants Emergency Use Authorization or product approval.
Upon authorization or approval, the U.S. government will distribute the doses and has committed to making them available at no cost, Regeneron said.
In the company announcement, Regeneron President and CEO Leonard S. Schleifer said: “We made the decision early on to begin large-scale manufacturing at our own risk in order to ensure that product would be available immediately if our clinical trials prove successful and an Emergency Use Authorization is granted. This manufacturing and supply agreement … could help REGN-COV2 reach many people quickly, hopefully helping to change the course of this deadly and still-raging pandemic."
Regeneron used the same techniques to develop REGN-EB3, a triple-antibody treatment for the Ebola virus that is now under review by the FDA.