- Gilead is working on its own remdesivir ramp-up, scouts licensing partners for global production.
- Gilead received the U.S. FDA’s emergency use authorization for using remdesivir as a treatment against COVID-19.
- The company also said it was in advanced talks with UNICEF to deliver remdesivir using the agency’s distribution networks.
- Trump to refocus coronavirus task force on economic revival, concedes risks.
Gilead Sciences Inc (GILD.O) is in discussions with chemical and drug manufacturers to produce its experimental COVID-19 drug remdesivir for Europe, Asia and the developing world through at least 2022, reports Reuters.
The drugmaker did not disclose details about the companies.
Remdesivir production is critical
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 drug-maker 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.
Drug patenting underway
Gilead is in talks to license the drug to the Medicines Patent Pool, a group that could then sub-license 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.
Remdesivir supply chains
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.
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.
Lives at risk
President Donald Trump said on Wednesday his coronavirus task force would shift its primary focus to reviving U.S. business and social life, while acknowledging that reopening the economy could put more lives at risk.
Trump’s Twitter comments drew swift criticism from the leading Democrat in Congress, House of Representatives Speaker Nancy Pelosi, who warned against easing restrictions prematurely.
“If you undermine science, if you underfund testing, if you exaggerate the opportunity that is out there for the economy at the risk of people dying, that’s not a plan,” Pelosi told MSNBC. “Death is not an economic motivator, stimulus. So why are we going down that path?”
White House guidelines recommend that new case numbers trend downward for 14 days and that wide-scale testing and contact tracing exist before shutdowns are phased out.
Dr. Anthony Fauci, the nation’s top infectious disease expert and best known member of Trump’s task force, acknowledged he was losing the argument against reopening the country too quickly.
“There are counties and cities in which you can do that safely now, but there are others that if you do that, it’s really dangerous,” he said on CNN.
While New York state, New Jersey and other early U.S. hotspots have lowered their infection curves since mid-April, a number of states, mainly in the Midwest, have posted sharp spikes in new cases and deaths.
Minnesota has set a record for new cases nine out of the last 14 days, including 728 cases on Wednesday.
Reopening of the task force
Trump said the White House will add two or three new members to the task force who will focus on reopening.
Fauci, who has at times openly contradicted Trump’s assertions about the pandemic, would remain on the panel along with Dr. Deborah Birx, a leading immunologist who has served as its coordinator.
As part of its new mission of spurring economic revival, Trump tweeted that the panel would remain “very focused on Vaccines & Therapeutics” – two areas crucial to a long-term return to normalcy.
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Source: Reuters
