The drug for which Gilead Sciences won an emergency use authorization from the Food and Drug Administration to treat Covid-19 has only been in the news for the past few months, but its development was several decades – and several billion dollars – in the making, according to a new study.
The study, conducted by the Center for Integration of Science and Industry at Bentley University and posted Wednesday on a preprint server, found the development of remdesivir was supported by $6.5 billion in funding for basic research by the National Institutes of Health. Foster City, California-based Gilead received an EUA for remdesivir as a treatment for hospitalized patients with Covid-19 in May, based on data from a randomized, placebo-controlled trial sponsored by the National Institute for Allergy and Infectious Diseases that showed it reduced the median time of recovery among patients from 15 to 11 days.
“Although it appears that remdesivir was approved in record time, this drug would not be available today if the NIH and others had not invested billions of dollars over the past decades in basic research on how different viruses work and the chemistry of nucleosides,” said Fred Ledley, the center’s director, in a statement. “While Gilead Sciences is investing billions of dollars in bringing this drug to the public, the substantial public sector investment that made this drug possible also needs to be recognized.”
In an emailed statement, a spokesperson for Gilead wrote that investment in remdesivir this year alone may exceed $1 billion, which does not include the initial investment the company made in its development. Remdesivir was originally developed as a treatment for Ebola virus, and its development for Covid-19 was based on preclinical research showing it had activity against SARS-CoV-1, the virus that caused the 2002-2004 severe acute respiratory syndrome outbreak, and MERS-CoV, the virus that causes Middle Eastern respiratory syndrome.
Remdesivir’s biological target is RNA-dependent RNA polymerase, or RdRp, and its parent chemical structure is known as a nucleoside analog, or NcAn. To conduct the study, the Bentley researchers looked through 6,567 research publications on RdRp, finding 1,263 that received support from the NIH, totaling $1.9 billion. They also found 11,073 publications on NcAn, finding 2,319 that received support from the NIH that totaled $4.6 billion. There were also 23 publications specifically on remdesivir published before the end of 2019, of which six included NIH funding worth $46.5 million. Since 1989, 97 drugs targeted to RdRp have entered clinical trials against various viruses, but the only three that have been approved first entered trials only after RdRp research had passed a maturity threshold. RdRp research itself dates back to the 1950s, according to the paper.
Last week, Gilead announced that it had given remdesivir a list price of $2,340 for a full course of treatment for government payers outside the U.S. and at $3,120 for commercial payers in the U.S., basing the former price on what would be considered affordable in developed countries with the lowest purchasing power. The U.S. price was based on how the system here is set up, and an analyst wrote that the anticipated discounts would likely bring it down to a level comparable to what it is in other countries. The analyst also wrote that the drug could yield $2.3 billion in revenue for Gilead this year.
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