Gilead, Merck to enhance production of anti-virals in India

Mumbai | Updated on April 28, 2021

Two American pharmaceutical companies, Gilead Sciences and Merck & Co, have taken steps to expand access to their drugs in India, through the voluntary licensing route.

Gilead committed support to Indian drug companies who are existing licensees to enhance production of its anti-viral, Remdesivir. It has also committed 450,000 vials of the injectable to the Indian government.

Merck Pharma entered into a VL deal on its investigational oral drug, Molnupiravir. Alliances were forged with five generic drug companies, Cipla, Hetero, Sun Pharma, Emcure and Dr Reddy’s Laboratories, to make and supply the drug to India and more than 100 LMICs. Merck Pharma is a wholly-owned subsidiary of Merck Sharp & Dohme (known as Merck & Co in the US and Canada). And the company was also in discussions with the Medicines Patent Pool to explore the potential for additional licenses, it added.

The efforts by the two US companies comes after US President Biden’s interaction with the Indian Prime Minister yesterday. And it comes even as India sees a surge in cases and patients get exposed to black-marketeers, when Remdesivir, for instance, is not available at the hospital.

Investigational drug

Molnupiravir is being studied in a Phase 3 trial for the treatment of non-hospitalised patients with confirmed Covid-19. MSD is developing Molnupiravir, in collaboration with Ridgeback Biotherapeutics, the company said.

The agreements would help accelerate access to Molnupiravir in India and around the world, said Kenneth C Frazier, Chairman and CEO, Merck & Co Inc. Rehan A Khan, Managing Director, MSD-India Region, said they were in talks with the government and other stakeholders to expand equitable access to medicines.

Merck & Co would also donate more than $5 million worth of oxygen-production equipment, masks, hand sanitisers and financial aid to support relief efforts in India, the company said.

Gilead, on its part said, it would provide its voluntary licensing partners with technical assistance, support for the addition of new local manufacturing facilities, and donate the active pharmaceutical ingredient (API) to rapidly scale up production of Remdesivir.

Remdesivir has an emergency use approval in India. And though the World Health Organisation has said that the drug was not “lïfe-saving”, doctors point out that it was useful in bringing down the days spent in a hospital.

Johanna Mercier, Chief Commercial Officer, Gilead Sciences, said: “Our immediate focus is to help address the needs of patients in India who may benefit from remdesivir as quickly as we can by working together with the government, health authorities and our voluntary licensees.”

All seven of Gilead’s licensees based in India (DRL, Hetero, Zydus Cadila, Syngene,Jubilant, Cipla and Mylan) have significantly accelerated production of Remdesivir by scaling up their batch sizes, adding new manufacturing facilities and/or onboarding local contract manufacturers across the country. This is expected to increase availability of remdesivir in the coming weeks, it said

Gilead’s voluntary licensing program for Remdesivir, established in May 2020, has helped more than 2.3 million people access the drug in more than 60 low- and middle-income countries, the company added.

Published on April 27, 2021

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