- Gilead is quickly ramping up production of its experimental coronavirus drug remdesivir, trimming by months the time it takes to make the antiviral treatment and securing needed raw materials in anticipation of overwhelming demand should the therapy prove effective.
- The biotech, now racing to study remdesivir in clinical trials in the U.S. and Asia, currently has on hand enough supply for about 140,000 treatment courses, depending on how it's administered. Company CEO Daniel O'Day wrote in a letter Sunday that Gilead hopes to make more than 1 million courses by year end.
- Gilead will donate its current supply at no charge for use in patient access programs and for initial distribution following any regulatory authorization that's granted in the future, O'Day wrote. Already, about 1,700 patients with COVID-19 have received remdesivir via compassionate use, a channel from which Gilead is shifting as more and more patients seek out the drug.
Gilead expects trial results from the first studies of remdesivir in COVID-19 will be available soon, likely within the next few weeks. Should data show the drug can ease symptoms or shorten the length of intensive care needed for patients with the disease, the company's supply will be nowhere near enough.
The biotech has previously committed to expanding manufacturing in preparation, but Sunday's letter from O'Day is the most detailed disclosure of Gilead's plans and capabilities.
Since January, when Gilead first began exploring whether remdesivir might have promise as an antiviral against SARS-CoV-2, the company has been working to build a supply chain capable of supporting large-scale manufacturing.
"[W]e needed to effectively start from ground zero in ramping up our supplies," wrote O'Day. Past studies of remdesivir as an Ebola virus therapy had left Gilead with a stockpile of both finished drug product and active ingredient. But Gilead doesn't have nearly enough remdesivir to provision the world in a pandemic.
Previously, making remdesivir took Gilead about a year from beginning to end, due in part to a chemical production process that had to be carried out in sequential steps. Over the past two months, Gilead scientists have cut that timeframe in half, an impressive feat but still a lengthy turnaround to address a viral disease that's spread globally in just two months.
Gilead has repurposed some of its own manufacturing facilities and tapped external contractors to help it produce more remdesivir, O'Day wrote. It hopes to produce enough drug for 800,000 treatment courses by October, and more than one million by the end of the year. Last month, the executive said Gilead has invested tens of millions of dollars in remdesivir ramp-up, and plans to spend hundreds of millions of dollars in the near future.
All of this is preparation in case testing proves remdesivir can benefit patients with COVID-19. Five mid- to late-stage studies are currently ongoing in China, the U.S. and elsewhere in Asia where the disease is prevalent.
If positive, the studies could spark soaring demand for remdesivir and critical questions for how Gilead should allocate its limited supply. Already, the company has run into some pushback over how it switched from accepting compassionate use requests to a broader expanded access program. While the shift is designed to help more people with COVID-19 receive remdesivir, an abrupt changeover in March appeared to cause some confusion.
Gilead has since communicated more frequently about the steps its taking to advance remdesivir, with O'Day penning open letters in late March and again on Sunday.