Gilead licenses remdesivir to increase global access

By The Science Advisory Board staff writers

May 13, 2020 -- Gilead Sciences has inked several agreements for the manufacture and distribution of remdesivir, which has been issued an emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA) on May 1.

Nonexclusive licensing agreements were made with Cipla, Mylan, and Hetero for remdesivir to treat COVID-19 patients. All companies will serve low- and middle-income countries, including India.

As part of their agreement, Cipla will manufacture active pharmaceutical ingredient (API) and finished product, and market the product globally under Cipla's brand name. Cipla will receive manufacturing expertise from Gilead in order to scale up commercial production. Cipla is the third largest pharmaceutical company in both India and South Africa.

In a similar agreement, Mylan will also manufacture and distribute remdesivir globally. Mylan will develop a bioequivalent version of the drug and produce its own API and finished dosage form in sterile powder lyophilized vial for intravenous infusion administration. Mylan is a global pharmaceutical company that specializes in generic, branded generic, brand name, and biosimilar drugs.

Hetero has likewise entered into an agreement with Gilead to manufacture and distribute remdesivir. The company has already developed their product in India and is working through the appropriate regulatory channels. The drug will be manufactured in Hetero's formulation facility in Hyderabad, India.

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