Gilead licenses remdesivir for Covid-19 to generic companies for sale in 127 countries

Five generic companies will have the right to manufacture and sell generic versions of the drug in mostly lower-income countries, as well as higher-income countries that face “significant obstacles” to healthcare access.

The company behind the first antiviral drug to receive an emergency use authorization for Covid-19 from the Food and Drug Administration has signed licensing deals with a handful of firms that will distribute generic versions in more than 100 countries around the world.

Foster City, California-based Gilead Sciences said in a statement Tuesday that it had signed non-exclusive voluntary licensing agreements with five generic companies mostly based in India and Pakistan – Cipla, Ferozsons Labs, Hetero Labs, Jubilant Lifesciences and Mylan – to manufacture and distribute the drug remdesivir in 127 countries.

Most of the countries are low- and lower-middle-income nations, as well as some upper-middle- and high-income countries with significant obstacles to healthcare access. They include Tajikistan, Georgia, Armenia, Belarus, India, Pakistan, Panama, Thailand, Cuba, Bermuda, Benin, Vietnam, Angola, Algeria, Morocco, Cambodia, Costa Rica and others.

The licenses are royalty-free until the World Health Organization declares an end to the Covid-19 emergency or until a drug other than remdesivir or vaccine receives approval to treat or prevent the disease, Gilead said. The license gives the generic companies a right to receive a technology transfer from Gilead for the remdesivir manufacturing process in order to scale up production, and the companies will be able to set their own prices.

The company has made similar deals to enable third-party companies to make cheaper versions of its drugs for developing countries before. For example it has for several years worked with manufacturers to allow the sale of cheaper versions of its hepatitis C and HIV drugs in lower-income countries.

The FDA granted the EUA for remdesivir at the beginning of the month after the announcement of early data from the National Institute of Allergy and Infectious Diseases’ Phase III study showing that the drug shortened the time for patients to recover from Covid-19 compared with placebo. However, the study did not show a statistically benefit in terms of being able to lower the death rate from the disease, and it remains unclear whether giving the drug earlier in the disease course could produce better outcomes. That’s because patients must be hospitalized in order to receive the drug – which is administered via a long intravenous drip – but patients do not typically go to the hospital until they are seriously ill.

Japan’s regulatory agency also granted approval to remdesivir, under the brand name Veklury, which Gilead registered with patent and trademark authorities in the U.S. and internationally in 2015.

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