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Gilead signs agreements with generics firms to manufacture and market remdesivir

Voluntary licensing deals allow firms to distribute drug recently granted FDA EUA to treat patients with COVID-19 in 127 countries

Gilead Sciences has signed agreements with five generic pharmaceutical manufacturers based in India and Pakistan allowing them to manufacture its antiviral drug remdesivir for distribution in 127 developing countries, the biotech company said on Tuesday.

Earlier this month, the US Food and Drug Administration issued an emergency use authorization for remdesivir for the treatment of severe COVID-19 in hospitalized patients, saying a clinical trial had shown the investigational drug to shorten recovery in some participants.

Under the voluntary non-exclusive licensing agreements, the companies -- Cipla, Ferozsons Laboratories, Hetero Labs, Jubilant Lifesciences and Mylan -- have a right to receive a technology transfer of the Gilead manufacturing process for remdesivir to enable them to scale up production more quickly.

Gilead said the licensees can also set their own prices for the generic product they produce.

“The licenses are royalty-free until the World Health Organization declares the end of the Public Health Emergency of International Concern regarding COVID-19, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent COVID-19, whichever is earlier,” the company said in a statement.

The 127 countries, which include India, Pakistan, South Africa and Nigeria, consist of nearly all low-income and lower-middle income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access.

Commenting on the deal, Mylan said it was confident it could develop a bioequivalent version of remdesivir, including production of its own active pharmaceutical ingredient (API) and the finished dosage form (FDF) in sterile powder lyophilized vials for administration of the medicine by intravenous (IV) infusion.

“We will be in a position to provide product in the coming months, subject to reviews by national regulatory bodies and the Prequalification Program of the WHO,” Mylan said in a statement.

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