Gilead in talks with Pakistani firms to produce corona drug remdesivir

Drug-maker Gilead Sciences Inc has said that it was in discussions with chemical and drug manufacturers in Pakistan to produce its experimental COVID-19 drug remdesivir for Europe, Asia and the developing world through at least 2022.

The drug-maker did not disclose details about the companies.

With several countries across the globe reeling from the virus outbreak, interest in remdesivir has been high as there are currently no approved treatments or vaccines for COVID-19, the respiratory illness caused by the new coronavirus.

Gilead last week received the US Food and Drug Administration's emergency use authorization for using remdesivir as a treatment against COVID-19, after the drug-maker provided data showing the drug had helped COVID-19 patients.

Gilead also said on Tuesday it was negotiating long-term licences with several generic drug-makers in Pakistan and India to produce remdesivir for developing countries and that it would provide technology to aid the production.

One of Bangladesh's largest drug-makers, Beximco Pharmaceuticals, will start remdesivir production this month.

Remdesivir was previously available only for patients enrolled in clinical trials or those cleared to get the drug under expanded use and compassionate use programmes.

Gilead, which has already said it will donate the first 1.5 million doses of remdesivir, also previously said it was focused on making the drug accessible and affordable to as many people as possible upon approval.

Gilead said it was working to build a consortium of manufacturing partners to help maximize global supply of the drug, which requires scarce raw materials and specialized manufacturing capabilities with limited global capacity.

The company also said it was in advanced talks with UNICEF to deliver remdesivir using the agency's distribution networks. 

Will there be enough for all patients?

How to make remdesivir both accessible and affordable to patients around the world –especially in developing countries–is one of the pressing challenges facing biopharma company Gilead.

The company is also negotiating long-term voluntary licenses with several generic drug-makers in Pakistan and India to produce remdesivir for developing countries –with appropriate technology transfers to help with the production. Gilead also said it’s talking with the Medicines Patent Pool to license remdesivir for developing countries.

“Any disruption to the supply chain impacting these scarce raw materials and other manufacturing inputs could reduce the amount of remdesivir produced and increase the time it takes to do so,” the company wrote in a statement.

Whether there will be enough supply for all the patients in need will also depend on the curve of the pandemic itself. In a Tuesday note before Gilead’s statement, RBC Capital Markets analyst Brian Abrahams estimated that under current production capability, the biopharma company might only be able to treat one third of US patients throughout the summer before supply catches up to demand starting in September.

Clinical data suggests that hospitalized patients with pneumonia and lower-than-normal blood oxygen saturation levels, but have shown symptoms for less than 10 days, could benefit the most from remdesivir, according to Abrahams.

About one in five diagnosed Covid-19 patients would fall into this group, based on epidemiology reports and CDC data. Applying that to the US, where daily new cases have stabilized at about 30,000 over the past week, that means roughly 6,000 people would need remdesivir daily for a period of five to 10 days.

Gilead CEO Daniel O’Day said in early April that the company was working to boost production of remdesivir, cutting the amount of time it takes to produce the drug from a year to six months. He said the company aimed to have 500,000 treatment courses manufactured by October, and one million by the end of 2020 .

Still, based on the volume of raw material currently finished or in final stages of production, Abrahams estimates Gilead can produce about 144,000 treatment courses of remdesivir from June to August. Even assuming daily new cases will decline 15% month-by-month throughout the summer, the production volume will fall far short of the demand from roughly 400,000 patients, he says, until output can ramp up.

Apparently, the calculation offers a framework with many variables that could turn out to be very different from the above expectations, including the evolving case rates, Gilead’s ability to meet manufacturing goals, demand outside of the US, and a potential second wave of infections as the economy gradually reopens.