Gilead in talks with pharma companies for voluntary licences on remdesivir

Biopharma company Gilead is in talks with chemical and pharma companies, including those in India and Pakistan, to produce its investigational drug remdesivir under a voluntary licence (VL).

The move reflects Gilead’s efforts to address access-related concerns being raised on its antiviral remdesivir that had shown to be effective in treating Covid-19. Earlier this week, the drug received the United States Food and Drug Administration’s “emergency use authorisation” for treatment against Covid.

In a statement, Gilead said it was in discussions with leading companies “about their ability, under voluntary licences, to produce remdesivir for Europe, Asia and the developing world through at least 2022.” The company is also negotiating long-term voluntary licences with several generic drugmakers in India and Pakistan to produce remdesivir for developing countries, it said. “Gilead will provide appropriate technology transfers to facilitate this production,” the US-based company said, without divulging details.

Until recently, Gilead had stopped short of mentioning a VL, though it indicated “collaboration” and efforts to establish a “geographically diverse consortium” to address access to remdesivir. A voluntary licence allows a set of companies to make less expensive versions of the innovator’s drug on payment of a royalty, and export it to select markets.

Tie-ups with Indian companies

Healthcare circles are of the opinion that Gilead would take the VL route on remdesivir, a strategy it adopted with its highly-priced Hepatitis C drug sofosbuvir. Gilead had tie-ups with generic drugmakers in India, including Cipla, Strides, Cadila Healthcare and Mylan, for example, on sofosbuvir. The expectation was for similar deals on remdesivir as well.

But as the death toll from the Covid pandemic increases, healthcare workers have called on governments to ensure that companies are not allowed to exercise patent exclusivities on their drugs, vaccines or medical technologies.

Patents pool

Gilead said it was also in “active discussions with the Medicines Patent Pool, which Gilead has partnered with for many years, to licence remdesivir for developing countries.” It added that it was also in “advanced discussions with UNICEF to utilise the extensive experience in providing medicines to low- and middle-income countries during emergency and humanitarian crises to deliver remdesivir using its well-established distribution networks.”

Close coordination of remdesivir manufacturing will be critical, Gilead said, explaining its efforts at a consortium of manufacturing partners to maximise global supply. “Producing the drug requires scarce raw materials, with their own lengthy production time, and specialised manufacturing capabilities with limited global capacity. 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 said.

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