On May 5, the company issued a statement describing their efforts.
Gilead Sciences’ antiviral drug remdesivir is, to date, the only approved drug treatment for COVID-19. Shortly after announcing positive results in two clinical trials on April 30, one a small trial run by the company, the other a larger trial conducted by the National Institutes of Allergy & Infectious Diseases (NIAID), the U.S. Food and Drug Administration (FDA) approved the drug under Emergency Use Authorization (EUA) for COVID-19.
Although not a cure, in the NIAID study, the drug appeared to speed recovery by about 31%, from about 15 days to 11 days. There was evidence of a survival benefit, which just narrowly missed being statistically significant, 8% compared to 11.6% in the placebo group.
The company-run trial suggested that there was similar improvement in a 5-day dosing regimen to a 10-day dosing regimen, which means that the supply of the drug will go further.
Now the company has the daunting task of scaling up manufacturing and distribution of a drug that reportedly takes approximately six months to produce for global distribution during a pandemic. On May 5, the company issued a statement describing their efforts.
Gilead is in talks with chemical and pharmaceutical manufacturing companies around the world to work out voluntary licenses to produce remdesivir for Europe, Asia and the developing world through at least 2022. “The company is also negotiating long-term voluntary licenses with several generic drugmakers in India and Pakistan to produce remdesivir for developing countries.”
As soon as is appropriate, the company will make the technology transfers needed for production of the drug. Gilead is also in talks with the Medicines Patent Pool to license the drug for developing countries.
Gilead is in discussions with UNICEF, which has extensive experience in distributing drugs to low- and middle-income countries during emergency and humanitarian crises. Gilead hope to use UNICEF’s distribution networks.
The drug is intravenous and initially took close to a year to manufacture. They have since cut the time down, but it is still a lengthy process. It requires a series of chemical reactions that need to be completed in a specific sequence with a manual inspection of each vial at the end of the process. Some of the steps require unique ingredients with limited supplies and several of the steps can take weeks.
“It’s not just the active ingredient — there are additives,” said Bernhardt Trout, a professor of chemical engineering at MIT. “Those have to be pharmaceutical grade and safe and tested. Every time you get an ingredient, you have to test that and make sure it falls within specifications. You have to analyze impurities. You have a quality control system. You have to then scale up your process to make millions of doses or whatever it is, and show that your process is robust because there are always variations.”
As a result, Gilead says, “Close coordination of remdesivir manufacturing will be critical. This is why Gilead is working to build a consortium of manufacturing partners—to bring efforts together to help maximize global supply. Producing the drug requires scarce raw materials, with their own lengthy production time, and specialized manufacturing capabilities with limited global capacity. Any disruption to the supply chain impacting these scarce raw materials and other manufacturing inputs could reduce the amount of remdesivir produced and increase the time it takes to do so.”
