Gilead, working on its own remdesivir ramp-up, scouts licensing partners for global production

Gilead on Friday won an FDA emergency use authorization for remdesivir in hospitalized patients with COVID-19. (Gilead Sciences)

Gilead Sciences can only produce so much of its newly authorized COVID-19 drug remdesivir, so it’s scouting other companies to bolster global supply. 

Even as it presses ahead with its own remdesivir ramp-up, Gilead says it’s in licensing talks with the “world’s leading chemical and pharmaceutical manufacturing companies” about their 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. Disruptions could reduce output or increase manufacturing time.

Gilead's also discussing long-term licensing deals with generics makers in India and Pakistan to produce the COVID-19 drug for the developing world. The Big Biotech would offer up its technology to get those companies started.

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Lastly, Gilead is in talks to license the drug to the Medicines Patent Pool, a group that could then sublicense it to generics companies for production for emerging markets. Gilead has already licensed several other medicines to the group, MPP’s website shows. 

Following Gilead's emergency FDA authorization, Bangladeshi company Beximco said it planned to produce the medicine for domestic use, Reuters reported. It wasn't clear whether Beximco had a license already.

On the distribution side, Gilead is in “advanced discussions” with UNICEF to use the humanitarian organization’s expertise in providing medicines to low- and middle-income countries during crises.  

RELATED: Gilead in talks to expand COVID-19 hopeful remdesivir supply chains with outside partner 

Gilead's supply and distribution update comes days after the company scored an FDA emergency use authorization for remdesivir in severe COVID-19. Before that authorization, CFO Andrew Dickson told analysts the company was working with "large sophisticated companies" to develop their own remdesivir supply chains. 

Late Friday, the FDA gave the drug the emergency authorization based on controlled data showing the medicine could cut recovery time for hospitalized patients by 31%. Under the authorization, the U.S. government is handling the distribution of the medicine.

RELATED: Fair price for Gilead's COVID-19 med remdesivir? $4,460, cost watchdog says 

After the emergency authorization, Gilead pledged to donate its existing supply, or about 1.5 million vials, enough for 140,000 patients. The company has not yet released its commercial plans despite repeated questions on the subject by analysts on last week's conference call. 

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