After scoring an early authorization for its COVID-19 therapy remdesivir, Gilead Sciences has been on the hunt for manufacturing partners to help boost production. Through a series of licensing agreements with generics makers, Gilead has taken the first steps to build that network.
Gilead signed nonexclusive licensing agreements with five generic drug makers operating in India and Pakistan to produce COVID-19 therapy remdesivir for 127 countries, the drugmaker said.
Gilead will work with Cipla, Mylan, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences to manufacture the drug primarily for low- and lower-middle income countries. The list also includes higher-income countries "that face significant obstacles to healthcare access," Gilead said.
Under the agreements, Gilead will share its manufacturing know-how with the five companies to help them gear up remdesivir production. Each company will be allowed to set the price for its own generic version of the drug.
The licensed drugmakers won't pay royalties to Gilead until the World Health Organization calls off the novel coronavirus public health emergency or until another therapy for COVID-19 is approved, Gilead said. Pfizer, which is developing a candidate with partner BioNTech, said Monday that it was evaluating the need for outsourcing production of some its drug portfolio to make way for a massive COVID-19 vaccine effort in the coming months.
Remdesivir scored an FDA emergency use nod earlier this month to treat severely ill COVID-19 patients.
Last week, Gilead said it was scouting for external partners to boost its ability to produce remdesivir for countries in Europe, Asia and beyond until at least 2022.
Remdesivir manufacturing relies on “scarce” raw materials that command their own “lengthy” production timelines, Gilead has said. Moving forward, coordination on producing the drug will be “critical,” the drugmaker says.
Gilead also said last week it was in talks to license the drug to the Medicines Patent Pool, an organization that could then sublicense it to generics companies for distribution in emerging markets. Gilead has already licensed several other medicines to the group, MPP’s website shows.
Gilead's push to bolster its remdesivir manufacturing comes as drugmakers across the board scramble to scale up production for their own possible therapies and vaccines.
Sunday, Regeneron CEO Len Schleifer told CNN's "State of the Union" that manufacturing capacity to fulfill global demand for a COVID-19 treatment or vaccine is "limited"––a troubling assessment from one of the drugmakers leading the fight for an answer to the novel coronavirus pandemic.
"If there's something we have to learn from this pandemic so that when COVID-21 or -25 or -32 comes along, we need a little bit more capacity already in place so that we can get it to everybody,” Schleifer said.