Less than two weeks after remdesivir controversially became the first Covid-19 treatment fully approved by the FDA, Germany is looking to lay claim to 5% of doses promised under an EU supply deal.
The 6-month deal allows the EU to purchase up to 3 million vials, according to a Reuters report — and Berlin wants 155,000 of them.
Gilead’s remdesivir — now marketed as Veklury — got full approval on Oct 22 to treat adults and children in the US who are older than 12 and require hospitalization for Covid-19. The drug also got a EUA for hospitalized children under 12 who weigh at least 3.5 kilograms, or any child weighing between 3.5 and 40 kg where the use of an IV is deemed appropriate.
The efficacy of the drug, though, was recently called into question by a WHO study. A preprint showed that Veklury didn’t have a substantial effect on improving mortality rates, reducing the amount of patients needing ventilators or shortening hospital stays. Gilead said it’s “concerned” the study wasn’t peer-reviewed. During a Q3 investor call, CEO Daniel O’Day said Gilead remains “fully committed to the investment.” Last quarter’s sales were pegged at $873 million.
Earlier this week, reports emerged that Russian biotech Pharmasyntez has asked the Kremlin for permission to make a generic version of the patented drug without Gilead’s consent. The company said it had plans to sell the generic at a steep discount: $540 for a 6-vial course, compared to Gilead’s five-day course at $3,120, according to Reuters.
Under the EU supply deal, a full course of Veklury would cost $2,407 (€2,070).
Sinopharm’s vaccine gets OK for emergency use in Bahrain
Another Chinese drugmaker has been granted emergency approval for its vaccine candidate — this one in Bahrain, according to a Reuters report.
Sinopharm’s candidate, developed with Abu Dhabi-based AI company Group 42, has been OK’d for use in frontline workers, Reuters reported. Back in July, it became the first inactivated candidate to enter a Phase III trial. It’s now nearing the end of Phase III studies in Egypt, Bahrain and Jordan. A Phase III trial in Abu Dhabi that began in July aimed to recruit 15,000 healthy volunteers from 18 to 60 years old.
Tianjin, China-based CanSino Biologics was the first to have a candidate approved for limited human use, when China’s government began allowing military members to take it. Since then, Russia has approved two vaccines — one from the Gamaleya Research Institute, and another from the Vector State Research Center of Virology and Biotechnology. Neither of the Russian candidates underwent large-scale clinical trials before getting the green light, drawing heavy criticism from scientists in other countries.
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