As India is fighting a surge in COVID-19 cases, Merck and Gilead have pledged to help by boosting supplies of their treatments to the country.
Gilead 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 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 remdesivir.
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. Gilead will also provide support to voluntary licensees based outside of India to increase production capacity.
Merck (known as MSD outside the United States and Canada) announced that it has entered into non-exclusive voluntary licensing agreements for molnupiravir with five established Indian generics manufacturers. Molnupiravir is an investigational oral antiviral agent currently being studied in a Phase 3 trial for the treatment of non-hospitalized patients with confirmed COVID-19. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics. Merck has entered into these agreements to accelerate availability of molnupiravir in India and in other low- and middle-income countries (LMICs) following approvals or emergency authorization by local regulatory agencies.
The agreements have been signed with Cipla Limited, Dr. Reddy’s Laboratories, Emcure Pharmaceuticals, Hetero Labs and Sun Pharmaceutical. Merck will provide licenses to these manufacturers to supply molnupiravir to India and more than 100 LMICs. Merck is also in discussions with the Medicines Patent Pool to explore the potential for additional licenses. The company will also donate $5 million worth of oxygen-production equipment, masks, hand sanitizer and financial aid to support relief efforts in India.
Read the Gilead statement
Read the Merck statement