Bangladesh pharma claims to be first to launch generic remdesivir

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Originally developed for other infectious diseases, remdesivir is indeed 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 sooner than those given placebo.

The finding prompted a flurry of regulatory activity to get remdesivir to more patients, with the meals and Drug Administration granting an authorization for emergency use and Japan approving it soon after. Supplies are tight, however, with Gilead only having readily available enough doses for 140,000 patients to be treated using the typical 10-day regimen.

The business has said it will donate the entirety of this supply but the majority is focused on the U.S., which includes already come across problems establishing an equitable and transparent distribution process.

As the U.S. is currently the epicenter of the coronavirus pandemic, globally some 5 million persons have already been infected and a lot more than 319,000 have died, making the necessity for confirmed treatments desperate.

Gilead has said it can ramp up production to create 1 million treatment courses by the finish of the year, but as the pandemic continues to take its toll, government and international organizations are looking for methods to reach patients more swiftly. The international generic licensing plan Gilead rolled out was one method to reach patients in 127 low- and middle-income countries.

Beneath the five agreements initially signed, companies like Mylan, Cipla and Hetero Labs will produce the drug under a non-exclusive license. They're absolve to set their own prices and won't have to pay Gilead royalty costs for so long as the World Health Organization maintains its declaration of a worldwide health emergency, or until a vaccine or drug apart from remdesivir is approved.

Beximco, which wasn't involved with 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 market, the company for now plans on focusing just on its home country, a spokesperson said.

However, the waiver allows the company to provide other least developed countries at their government's request. Beximco is merely at an early on 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 had not been among the licensees it has registered up to now. “Gilead cannot comment on or verify the authenticity or effectiveness of the product as it isn't created by Gilead or among our qualified partners," the statement read.
Source: https://www.biopharmadive.com

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