To help India with increased supply of investigational oral Covid-19 drug molnupiravir (EIDD-2801/MK-4482) amid the country’s surge of coronavirus cases, Merck (MSD) has signed non-exclusive voluntary licensing agreements with five established Indian generics manufacturers.
The agreements have been signed with Cipla, Dr Reddy’s Laboratories, Emcure Pharmaceuticals, Hetero Labs and Sun Pharmaceutical Industries which have World Health Organization (WHO) prequalified manufacturing facilities and capability as key suppliers to global and key low and middle-income countries (LMICs).
Being developed by the company in partnership with Ridgeback Biotherapeutics, molnupiravir is an investigational, orally bioavailable form of a potent ribonucleoside analogue that hinders the replication of various RNA viruses, including SARS-CoV-2.
This development, which comes amid the humanitarian crisis in India, will aid Merck in expediting molnupiravir availability in India and various LMICs on obtaining approvals or emergency authorisation from the local regulatory authorities.
According to the agreements, these manufacturers will receive licenses to supply molnupiravir to India and over 100 LMICs.
Furthermore, Merck is holding talks with the Medicines Patent Pool (MPP) to analyse the possibility of more licenses.
To aid relief efforts, Merck will donate over $5m worth of oxygen-production equipment, masks, hand sanitiser as well as financial aid to India.
Merck chairman and CEO Kenneth Frazier said: “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.”
The antiviral agent is currently being evaluated in a Phase III trial for treating non-hospitalised Covid-19 patients.
Molnupiravir has demonstrated to be active in various models of SARS-CoV-2, including prophylaxis, treatment and prevention of transmission, as well as SARS-CoV-1 and MERS.
Last month, Merck and Ridgeback reported preliminary results from a Phase IIa trial of molnupiravir for Covid-19.