Russian drugmaker Pharmasyntez has asked the Kremlin to produce a generic version of U.S. COVID-19 drug remdesivir despite lacking a patent to do so.
Pharmasyntez has asked the Kremlin to activate a compulsory licensing process on the basis of national security, granting it the right to produce the generic – labelled Remdeform – without Gilead’s consent.
Remdesivir is not available in Russia, Pharmasyntez’s director Vikram Punia said, but a generic version cannot be produced and distributed without the consent of the patent-holder, U.S. firm Gilead Sciences GILD.O.
Gilead has already granted voluntary licences to producers in 127 countries, predominantly low-income countries or those with other significant obstacles to healthcare access.
Pharmasyntez wrote to the U.S. firm in July requesting its consent in the form of a voluntary licence, but did not hear back, Punia said.
The FDA formally approved the drug, despite recent results from a World Health Organization-sponsored trial.
Punia said the company could market its drug at a significantly lower cost of around $540 for a 6-vial course. A five-day course of Gilead’s remdesivir, marketed under the brand name Veklury, has been pricaed at $3,120.
For more information:
NIH – U.S. National Institutes of Health
Final report confirms remdesivir benefits for COVID-19 (October 20, 2020)
Food and Drug Administration FDA
FDA Approves First Treatment for COVID-19 (October 22, 2020)
Remdesivir and interferon fall flat in WHO’s megastudy of COVID-19 treatments (Oct. 16, 2020)
The New England Journal of Medicine
Remdesivir for the Treatment of Covid-19 — Final Report (October 8, 2020)
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