Gilead CEO: Remdesivir could be the benchmark for COVID-19 drug development

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New data “changes the landscape for drug development within COVID-19 in that one has to now think about comparing to remdesivir and/or looking at adding to remdesivir,” said Daniel O’Day. (NIH)

When the first data emerged Wednesday from a placebo-controlled study of Gilead Sciences' remdesivir, analysts agreed that it “appears to help,” but it was no “silver bullet.” But it doesn’t need to be, said Anthony Fauci, M.D., director of the National Institutes of Health body that sponsored the study. Instead, he sees the drug as a steppingstone to better treatments that could even be combined for a greater effect—an idea also held by Gilead CEO Daniel O’Day.

The National Institute of Allergy and Infectious Diseases study pitted remdesivir against placebo in more than 1,000 patients hospitalized because of COVID-19. Those data, along with results from Gilead’s own open-label study in patients with severe disease, “changes the landscape for drug development within COVID-19 in that one has to now think about comparing to remdesivir and/or looking at adding to remdesivir,” O’Day said Thursday during Gilead’s first-quarter earnings call.

The sentiment echoes the thoughts Fauci shared when he announced the data during a White House briefing. “What it has proven is a drug can block this virus … All of the other trials that are taking place now have a new standard of care,” he said.

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Both Fauci and O'Day—whose company is the market leader in HIV—likened today’s drug development efforts against COVID-19 to those for an HIV treatment decades ago. Just as the biopharma industry improved upon and added to HIV treatments, O'Day expects it to develop better drugs for COVID-19, whether they are antivirals like remdesivir or other types of treatments.

And the industry is already on it, he said.

“All of our collaborators within the drug development space, we have been working with them and continue to work with them on the most thoughtful hypotheses: symptomology improvement, mortality improvement, expanding the patient population,” he said on the call.

One part of those efforts is an alternative formulation of remdesivir, which is currently given by intravenous infusion. As the company plugged away at making enough of the drug for clinical trials, it's also been working on other versions of the candidate including an inhaled form as well as one given through an injection just under the skin, O’Day said. The drug is “not appropriate as an oral medication,” but that’s something Gilead has known for years—“probably decades,” he said.

Those methods “might make [remdesivir] more convenient for patients or broaden the patient group that could benefit from a successful antiviral,” O’Day said. Evercore ISI analyst Umer Raffat, for his part, wrote in a note to clients Thursday that an inhaled version of the drug might be able to reduce the disease's viral load and improve outcomes for patients.

But those formulations could be pretty far off.

“That work, as you can imagine, is still early," O'Day said, adding, "as soon as we can give timelines, we will.”

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