The multiyear agreement will support efforts to scale up the supply of the intravenous drug, which has been shown to help shorten the recovery time of some hospitalized coronavirus patients, the company said. Pfizer will manufacture the drug at its McPherson, Kansas, facility.
There are no FDA-approved drugs for the coronavirus, which has infected more than 19 million people worldwide and killed at least 715,163 in about seven months, according to data compiled by Johns Hopkins University.
But doctors have been using remdesivir on Covid-19 patients in recent months. In May, the Food and Drug Administration granted remdesivir an emergency use authorization, allowing hospitals and doctors to use the drug on hospitalized Covid-19 patients even though the medication has not been formally approved by the agency.
Additionally, Gilead said it plans to produce more than 2 million treatment courses of the drug by the end of the year and anticipates being able to make “several million more” in 2021, adding it has increased supply of the drug more than fiftyfold since January. Its manufacturing network now includes more than 40 companies in North America, Europe and Asia.
The Department of Health and Human Services announced June 29 a deal that gives the U.S. more than 500,000 treatment courses of the antiviral drug for U.S. hospitals through September. That represents 100% of Gilead’s projected production for July and 90% of production for August and September, according to the agency.
The deal comes as Pfizer continues its effort to produce a potential vaccine for the coronavirus. Last week, the company said it began a late-stage trial that will include about 30,000 participants.
If it is successful, Pfizer and its vaccine development partner BioNTech expect to submit it for final regulatory review as early as October. They plan to supply up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021.