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After donation to the U.S., Gilead outlines plans to distribute COVID-19 drug worldwide

Gilead on Tuesday said it is negotiating with overseas drug manufacturers to license its coronavirus treatment remdesivir in an effort to speed global access. Agreements covering Europe and Asia would extend through 2022, Gilead said, while longer-term pacts for developing countries are also being worked out.The biotech is also working with UNICEF to distribute remdesivir to low- and middle-income countries through the charity’s established networks, as well as with the Medicines Patent Pool for further licensure in developing countries.The announcement came just four days after the Food and Drug Administration authorized the drug’s use in the U.S. on an emergency basis. Gilead has been under pressure to ensure remdesivir is accessible and affordable, years after it faced a torrent of criticism for pricing its first hepatitis C drug at $1,000 a pill.

Gilead said it is negotiating with “some of the world’s leading chemical and pharmaceutical manufacturing companies” to produce remdesivir for Europe, Asia and the developing world through 2022, as well as “long-term voluntary licenses” with generic manufacturers in India and Pakistan to supply the drug to developing countries.

This plan is similar to what Gilead has done in the past to aid distribution of antiviral drugs to developing countries in particular. For example, after its hepatitis C medicine Sovaldi launched with an infamously high price tag, Gilead agreed to a non-exclusive license with seven generic manufacturers to sell the drug in 91 developing countries.

The company has also previously cut deals with the Medicines Patent Pool to help manufacture its hepatitis C and HIV drugs in developing countries. Despite those efforts, the company has remained a target of scrutiny for its pricing practices, which some fear will again be an issue with remdesivir.

With data showing the closely-watched antiviral can shorten hospital stays for advanced COVID-19 patients, policymakers’ attention has turned to how to get remdesivir to as many patients as possible.

The FDA’s Emergency Use Authorization issued last week specified the U.S. government will control distribution of Gilead’s current supplies of remdesivir, which the company previously said it would donate.

That doesn’t help the rest of the world, of course, even if the U.S. is now the globe’s hardest-hit nation with 1.2 million confirmed cases through May 6.

On Monday, Michael Ryan, executive director of the World Health Organization’s emergencies program, said the WHO is “engaging in discussions” with the U.S. government and Gilead on global distribution.

Reuters reported Tuesday that an executive with the Bangladesh-based generics company Beximco plans to produce remdesivir and set a price of no more than about $780 per patient.

The Institute for Clinical and Economic Review, a U.S. drug cost watchdog, said remdesivir would be cost-effective at a price of $4,460, if it helps reduce patients’ risk of dying. If not, it would be cost-effective only at $390 on the basis of helping patients leave the hospital sooner, ICER said. Thus far, remdesivir has only definitively shown it can shorten hospital stays.