Gilead outlines plans for global expansion of remdesivir production

Biotech in discussions with pharmaceutical and chemical manufacturers on how to broaden supply of antiviral that last week received an emergency use authorization for treatment of COVID-19 from the FDA

Last week, the US Food and Drug Administration issued an emergency use authorization for remdesivir for the treatment of severe COVID-19 in hospitalized patients, saying a clinical trial had shown the investigational drug to shorten recovery in some participants.

“Close coordination of remdesivir manufacturing will be critical,” Gilead said in a statement, adding that it is working to build a consortium of manufacturing partners to pool efforts 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,” the company said.

Gilead said the discussions revolved around manufacturers’ ability to produce remdesivir for markets in Europe, Asia and the developing world on a voluntary license basis 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. Gilead will provide appropriate technology transfers to facilitate this production,” Gilead said.

Gilead said it is also in discussions with long-term partner, the Medicines Patent Pool, to license remdesivir for developing countries.

The FDA's emergency use authorization for remdesivir stated that distribution of the drug will be controlled by the US government.

Earlier this week, Gilead chairman and CEO Daniel O’Day told reporters the company has donated 1.5 million vials of the drug, amounting to between 100,000 and 200,000 treatment courses, depending on dosage.

He added that the US government would begin shipping tens of thousands of treatment courses out this week and would adjust distribution as the epidemic shifts and evolves in different parts of the country.

Last month, O’Day said the company had managed to reduce the end-to-end manufacturing timeline for remdesivir from one year to around six months.

“Our existing supply, including finished product ready for distribution as well as investigational medicine in the final stages of production, amounts to 1.5 million individual doses,” he said, adding that Gilead was providing this existing supply at no cost to treat patients with the most severe symptoms of COVID-19.

In a preliminary modelling exercise, the US Institute for Clinical and Economic Review said remdesivir could be priced at USD 4,460 per patient and still be cost-effective when being used as a treatment for hospitalized patients with advanced COVID-19 and lung involvement.