Gilead Inks Non-US Deals With Five Generic Drugmakers to Expand Supply of COVID-19 Drug Remdesivir

Gilead Sciences said it has signed non-exclusive voluntary licensing agreements with Cipla, Ferozsons Laboratories, Hetero Labs, Jubilant Lifesciences and Mylan to manufacture COVID-19 treatment remdesivir for distribution in 127 countries. According to Gilead, the list consists of nearly all low- and lower-middle income countries, as well as several upper-middle- and high-income countries “that face significant obstacles to healthcare access.”

The licensing agreements give the companies a right to receive a technology transfer of Gilead’s manufacturing process for remdesivir to allow them to scale up production more quickly. They can also set their own prices for the generic products they produce. Gilead noted that the licenses are royalty-free until the World Health Organization announces an end to the “public health emergency of international concern” regarding COVID-19 that it declared earlier this year, or until a pharmaceutical product other than remdesivir, or a vaccine, is approved to treat or prevent the novel coronavirus, whichever comes first.

Among the 127 countries are India, Pakistan, South Africa, Thailand and the Philippines, as well as some in Eastern Europe such as Belarus and the Ukraine, but not China or Russia. The US, where remdesivir was granted an emergency-use authorization earlier this month, is also not on the list, and neither is Japan, which has itself recently issued an “exceptional approval” to the drug for use in patients with severe COVID-19.

Mylan stated it believes it will be able to develop a bioequivalent version of remdesivir, including production of its own active pharmaceutical ingredient and the finished dosage form in sterile powder lyophilised vials for administration by intravenous infusion. The company added “we will be in a position to provide product in the coming months,” subject to reviews by national regulatory bodies and the World Health Organization’s prequalification programme.

A report earlier this week said Gilead is donating about 607,000 vials of remdesivir in the US over the next six weeks, less than half of its worldwide donation of 1.5 million doses of the COVID-19 treatment. The move surprised RBC analyst Brian Abrahams, who said he had been expecting 80% of Gilead’s donation to be distributed in the US.