PremiumMSD Pharmaceuticals Pvt Ltd, a wholly-owned subsidiary of Merck Sharp & Dohme (MSD), on Tuesday announced it has signed non-exclusive voluntary licensing agreements with five established Indian generic manufacturers—Sun Pharmaceutical Industries, Cipla, Dr Reddy’s Laboratories, Emcure Pharmaceuticals and Hetero Labs—to contract manufacture the covid-19 drug molnupiravir.
Molnupiravir is an investigational oral antiviral drug, currently being studied in a phase 3 trial for the treatment of non-hospitalized patients with confirmed covid-19. The agreements are aimed at accelerating availability of molnupiravir in India and in other low- and middle-income countries (LMICs) following approvals or emergency authorization by local regulatory agencies.
“We are in talks with the Government and other key stakeholders as we remain committed to expanding equitable access to medicines and bringing innovative treatments to the country," Rehan A Khan, managing director of MSD-India Region, said in the statement.
Hetero Group chairman B. Partha Saradhi Reddy said that the company will soon approach the Drugs Controller General of India for a regulatory authorisation.
“We are vertically integrated to manufacture and commercially ready to supply this product to patients swiftly across the country. We will be immediately approaching the DCGI to seek regulatory pathway and emergency use authorization," Reddy said.
MSD is developing molnupiravir in collaboration with Ridgeback Biotherapeutics.
“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," said Kenneth C. Frazier, chairman and chief executive officer of Merck & Co, said. MSD is known as Merck & Co in US and Canada.
Under the agreements, Merck & Co., Inc., US will provide licenses to these manufacturers to supply molnupiravir to India and more than 100 LMICs.
Merck & Co is also in discussions with the United Nations-led Medicines Patent Pool to explore the potential for additional licenses.
