Russian drugmaker Pharmasyntez has asked the Kremlin to allow it to produce a generic version of U.S. COVID-19 drug remdesivir, used to treat U.S. President Donald Trump, despite lacking a patent to do so, the firm’s director said on Monday, as reported by Reuters.
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.
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 Siberian-based drugmaker is now asking 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.
“Many people’s lives could be saved using this drug. The longer this drug is inaccessible, the more people we will lose,” Punia said.
The law has not been used on behalf of a pharmaceutical product in Russia before, Punia said after the Vedomosti newspaper reported on his company’s letter to the Kremlin earlier on Monday.
Gilead could not immediately be reached for comment outside normal business hours on Monday. It has already granted voluntary licences to producers in 127 countries, predominantly low-income countries or those with other significant obstacles to healthcare access.
Russia registered a record high daily tally of 18,665 new coronavirus cases on Sunday, bringing the total number since the pandemic began to 1,655,038.
Remdesivir was granted emergency use authorization by the U.S. Food and Drug Administration in May after it was shown to shorten hospital stays for COVID-19 patients in a government-run clinical trial. It was one of the treatments given to Trump during his recent bout of the disease.
The FDA formally approved the drug this month, despite recent results from a World Health Organization-sponsored trial showing remdesivir did not improve patient outcomes.
Pharmasyntez has completed a clinical trial of the generic drug on 300 COVID-19 patients across 23 Russian hospitals, according to a register entry.
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.