One day after it started Phase III testing of an antibody cocktail that could be used for COVID-19 patients, Regeneron said it signed a $450 million deal with the U.S. government to make and supply the treatment.
The contract, part of the government’s «Operation Warp Speed» program, will see the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense purchase doses of REGN-COV2 for immediate use in the U.S.
It assumes the Phase III testing is successful and the FDA grants emergency use approval of the cocktail, according to a statement from the Tarrytown, N.Y.-based biotech.
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«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,» Regeneron’s CEO, co-founder and president Dr. Leonard Schleifer said in the statement. «This manufacturing and supply agreement with BARDA and the Department of Defense could help REGN-COV2 reach many people quickly, hopefully helping to change the course of this deadly and still-raging pandemic.»
The deal between the government and Regeneron, which is expected to be completed by the fall of 2020, will see the number of treatment doses range between 70,000 and 300,000 or 420,000 to 1.3 million prevention doses, with initial doses «as early as end of summer,» Regeneron added in the statement.
«If EUA or product approval is granted, the government has committed to making doses from these lots available to the American people at no cost and would be responsible for their distribution,» the statement continued.
On Monday, Regeneron said it was starting Phase III of its double-antibody treatment, evaluating REGN-COV2’s ability to prevent infection in people who have yet to be infected with the virus, but have had «close exposure to a COVID-19 patient (such as the patient’s housemate).»
The study is being done in conjunction with the National Institute of Allergy and Infectious Diseases.
The Phase III portion of the trial is being conducted at «approximately 100 sites» and the company is looking to enroll 2,000 patients across the U.S.
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In addition, Regeneron noted that REGN-COV2 is also in the Phase II/III portion of testing to see if the cocktail can treat both hospitalized and non-hospitalized COVID-19 patients.
The congruent Phase II/III testing will be done with approximately 2,900 (1,850 hospitalized, 1,050 non-hospitalized) patients across the planet, including places in the U.S., Brazil, Mexico and Chile.
There is no known scientific cure for the disease known as COVID-19, however, a number of drugs are being tested to see if they can treat it.
In late June, Gilead Sciences said that its antiviral drug remdesivir, which has been granted emergency use approval in the U.S. and is approved in Europe and Japan, would potentially cost more than $3,000 in the U.S. for treating SARS-CoV-2.
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As of Tuesday morning, more than 11.65 million coronavirus cases have been diagnosed worldwide, more than 2.94 million of which are in the U.S.