Gilead Sciences, Inc announced that in response to the rapid increase in COVID-19 cases in India, the company is providing its voluntary licensing partners with technical assistance, support for the addition of new local manufacturing facilities and the donation of active pharmaceutical ingredient (API) to rapidly scale up production of remdesivir. Remdesivir is approved in India for restricted emergency use for the treatment of suspected or laboratory confirmed COVID-19 in adults and children hospitalized with severe disease. 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 help address the immediate needs of Indian patients.
“The recent surge of COVID-19 cases in India is having a devastating impact on communities and has created unprecedented pressure on health systems,” said Johanna Mercier, Chief Commercial Officer, Gilead Sciences. “We are committed to doing our part to help tackle this crisis. 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. While these efforts are expected to increase availability of remdesivir in the coming weeks, Gilead will donate at least 450,000 vials of Veklury to the Government of India to help ease the immediate need for treatment.
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.
Gilead’s voluntary licensing program for remdesivir, established in May 2020, has already enabled access to the drug for more than 2.3 million people in more than 60 low- and middle-income countries. The program, which builds on Gilead’s pioneering voluntary licensing model for its HIV and viral hepatitis medicines, provides long-term licenses 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 licenses remain royalty-free, reflecting Gilead’s existing commitment to enabling broad patient access to remdesivir.
