Merck announces voluntary licensing agreements with five Indian generics manufacturers to boost access to COVID-19 therapeutic

Merck has reached voluntary licensing agreements with five Indian generics manufacturers to produce molnupiravir for the COVID-stricken nation, granting it another oral therapeutic to aid the COVID-19 pandemic.

While molnupiravir is currently being studied in a phase three trial to treat non-hospitalized patients with COVID-19, these agreements will allow Merck to accelerate the availability of the therapeutic in India and other low and middle-income countries following approvals or emergency authorization by regulatory agencies.

Merck will couple this with donations of more than $5 million in supplies and equipment to aid relief efforts in India. This equipment will include oxygen-production equipment, masks, and hand sanitizer, but financial aid, in general, will also be provided.

“The scale of human suffering in India at this moment is devastating, and it is clear that more must be done to help alleviate it. These agreements, toward which we have been working as we have been studying molnupiravir, will help to accelerate access to molnupiravir in India and around the world,” Marck Chairman and CEO Kenneth Frazier said. “We remain committed to aiding in the global response that will bring relief to the people of India and, ultimately, bring an end to the pandemic.”

All five of the generics manufacturers — Cipla Limited, Dr. Reddy’s Laboratories Limited, Emcure Pharmaceuticals Limited, Hetero Labs Limited, and Sun Pharmaceutical Industries Limited — have World Health Organization (WHO) pre-qualified manufacturing facilities and experience as suppliers for low- and middle-income countries. These will gain licenses for molnupirvir in India as well as more than 100 of these countries.

Molnupiravir remains in development through a collaboration between Merck and Ridgeback Biotherapeutics. At this time, Merck is also discussing the possibility of additional licenses with the Medicines Patent Pool.