Gilead supports licensees in India to scale up Remdesivir production

PT Jyothi Datta Mumbai | Updated on April 27, 2021

To donate over 4 lakh vials of the drug to the Government

American biotech company Gilead Sciences has said that it was taking steps to increase the availability of antiviral Remdesivir in India by supporting its licensees to scale up production and donating over 4 lakh vials of the drug to the Government.

This comes even as India sees a surge in cases and patients get exposed to black-marketeers, while the injectable is not available at the hospital.

Gilead 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. Though the World Health Organization 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.

In addition to providing support to its licensees to expand their local manufacturing capacity, Gilead will also donate at least 450,000 vials of Veklury® (remdesivir) to the Indian government to help address the immediate needs of Indian patients.

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 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.

To safeguard against disruption of generic remdesivir supply to other low- and middle-income countries included as part of the voluntary licenses, Gilead is also committed to providing support to voluntary licensees based outside of India to increase their production capacity. Gilead’s planned support will include the donation of API to licensees with a view to accelerate production, it added.

Gilead’s voluntary licensing programme 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 said.

The programme, which builds on Gilead’s earlier voluntary licensing model for its HIV and viral hepatitis medicines, provides long-term licences to nine manufacturers, seven of which are based in India, to enable access to remdesivir in 127 countries, most of which are low- and low-middle income countries, including India. These licences remain royalty-free, reflecting Gilead’s existing commitment to enabling broad patient access to remdesivir, it said.

Published on April 27, 2021

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