Iran Claims It’s Using a Remdesivir Generic to Fight Covid-19

By Arsalan Shahla and Golnar Motevalli – August 10, 2020

Drug won’t be sold commercially and meant for hospitals only

Human trials of a home-grown vaccine to start within 2 weeks

Iran says it has started distributing its generic version of Gilead Sciences Inc.’s remdesivir antiviral drug to aid the country’s fight against Covid-19.

The Food and Drug Organization of Iran said last week that an “Iranian remdesivir” had been sent to university hospitals and specialist clinics, state-run Islamic Republic News Agency reported, citing the organization’s chief, Mohammadreza Shanehsaz. There are no plans to sell the drug commercially for now, it said.

Iran’s ability to tackle the worst coronavirus outbreak in the Middle East has been hampered by both U.S. sanctions and poor enforcement of social distancing rules and mask-wearing as the government rolled back restrictions to rescue the economy. It also expects to start human trials of a locally developed vaccine within two weeks, according to Tasnim news agency.

Gilead didn’t respond to an email sent over the weekend or a phone message on Monday requesting comment on Iran’s claims.

According to its website, the company signed non-exclusive voluntary licensing agreements allowing generic makers in Egypt, Pakistan and India to manufacture and distribute remdesivir to 127 listed countries, many of them low-income nations. The licensees can set their own prices for the generic they produce, it said. Iran and most of its neighbors aren’t on the list.

Remdesivir is one of the first widely used drugs for Covid-19. It received emergency use authorization from U.S. regulators in May, after a large trial found it sped recovery by about four days in hospitalized patients. Hundreds of treatments and vaccines are in development around the globe as researchers race to find ways to halt the global pandemic.

State TV on Aug. 3 reported on a production line for the remdesivir generic at the Sobhan Oncology pharmaceutical company, a subsidiary of the Setad foundation controlled by Supreme Leader Ayatollah Ali Khamenei, suggesting Iran had reverse-engineered the drug, possibly using supplies provided by the World Health Organization.

The Iranian company plans to export the generic to Iraq, Lebanon, Syria and Afghanistan once domestic demand is met, the report said. Iran’s also producing FUJIFILM Toyama Chemical Co.’s favipiravir, another antiviral used to treat Covid-19.

Calls to Sobhan Oncology’s public relations department weren’t answered, and there’s no data publicly available on clinical trials of the remdesivir generic.

“With the exorbitant prices of the original remdesivir in the black market, we have no choice but to trust the Iranian equivalent,” said Reza, a pharmacist who didn’t want to be identified because of the sensitivity of speaking with foreign media in Iran. “We don’t have to worry too much because the drug has certainly passed various clinical tests and filters before reaching the production stage.”

The state-run Young Journalist’s Club in July reported that vials labeled as either remdesivir or favipiravir were being sold on unauthorized markets in Iran for as much as 100 million tomans ($4,545).

California-based Gilead said in June that it will charge U.S. hospitals roughly $3,120 for most patients who need remdesivir. Patients suffering from the illness caused by the novel coronavirus are usually given six vials of the drug over five days.