- Bangladesh-based drug manufacturer Beximco says it has launched the first generic version of Gilead's coronavirus treatment remdesvir, which it will donate to government-owned hospitals in the South Asian country.
- Beximco was not one of the five global generics companies licensed by Gilead to produce the drug for low- and middle-income countries, but claims it has the right to do so for Bangladesh and other less developed countries under a drug patent waiver via World Trade Organization rules.
- Now that a clinical study has shown remdesivir helps patients recover from severe coronavirus infections faster, Gilead faces difficult questions over how to allocate and fairly distribute the drug. Patient advocates criticized the biotech's initial licensing plan, arguing that half the world's population falls outside the countries specified by the company's agreements.
Originally developed for other infectious diseases, remdesivir is so far the only drug supported by positive data from a randomized, placebo-controlled study of patients hospitalized with COVID-19. Results, announced by the U.S. National Institutes of Health last month, showed treatment helped hospitalized patients recover four days earlier than those given placebo.
The finding prompted a flurry of regulatory activity to get remdesivir to more patients, with the Food and Drug Administration granting an authorization for emergency use and Japan approving it soon after. Supplies are currently tight, however, with Gilead only having on hand enough doses for 140,000 patients to be treated using the standard 10-day regimen.
The company has said it will donate the entirety of that supply but the majority is dedicated to the U.S., which has already run into problems establishing an equitable and transparent distribution process.
While the U.S. is now the epicenter of the coronavirus pandemic, globally some 5 million people have been infected and more than 319,000 have died, making the need for proven treatments desperate.
Gilead has said it can ramp up production to make 1 million treatment courses by the end of the year, but as the pandemic continues to take its toll, government and international organizations are looking for ways to reach patients more swiftly. The international generic licensing plan Gilead rolled out was one way to reach patients in 127 low- and middle-income countries.
Under the five agreements initially signed, companies like Mylan, Cipla and Hetero Labs will produce the drug under a non-exclusive license. They're free to set their own prices and won't have to pay Gilead royalty fees for as long as the World Health Organization maintains its declaration of a global health emergency, or until a vaccine or drug other than remdesivir is approved.
Beximco, which wasn't involved in those agreements, says it's starting production under Bangladesh's waiver from World Trade Organization intellectual property rules for least developed countries. Headquartered in Bangladesh but listed on the London stock exchange, the company for now plans on focusing just on its home country, a spokesperson said.
However, the waiver would allow the company to supply other least developed countries at their government's request. Beximco is only at an early stage of exploring that possibility, the spokesperson said.
The spokesperson said Beximco plans on producing 100,000 vials, or enough for at least 9,100 patients.
In a statement emailed to BioPharma Dive, Gilead noted that Beximco was not among the licensees it has signed up so far. “Gilead cannot comment on or verify the authenticity or effectiveness of this product as it is not manufactured by Gilead or one of our licensed partners," the statement read.