MSD to sign licensing pacts with 5 Indian drug firms for oral drug candidate for COVID-19

Drug firm MSD has decided to enter into voluntary licensing agreements for investigational oral antiviral drug candidate ‘molnupiravir’, which is being studied for the treatment of COVID-19, with Indian drug firms Sun Pharma, Cipla, Dr Reddy’s, Emcure Pharma and Hetero Labs, its Indian arm said on Tuesday. Molnupiravir is an investigational oral antiviral agent, currently being studied in a Phase 3 trial for the treatment of non-hospitalised patients with confirmed COVID-19, MSD India said in a statement. MSD India is a wholly owned subsidiary of Merck Sharp & Dohme (MSD) and known as Merck & Co., Inc, in the United States and Canada.

MSD has decided to enter into non-exclusive voluntary licensing agreements for molnupiravir with five established Indian generic manufacturers — Cipla, Dr Reddy’s Laboratories, Emcure Pharmaceuticals, Hetero Labs and Sun Pharmaceutical Industries, it added. These five manufacturers have World Health Organization (WHO) Pre-Qualified Manufacturing facilities and experience as major suppliers to global and key low- and middle-income countries (LMICs) procurers, MSD India said. MSD has entered into these agreements to accelerate availability of molnupiravir in India and in other LMICs following approvals or emergency authorisation by local regulatory agencies, it added. “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,” Merck & Co, Inc, US Chairman and CEO Kenneth C Frazier said.

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“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,” he added. Under the agreements, Merck & Co, Inc, US will provide licences to these manufacturers to supply molnupiravir to India and more than 100 LMICs. The company is also in discussions with the Medicines Patent Pool to explore the potential for additional licenses, the statement said. “Through partnerships with established Indian generics manufacturers, we are reinforcing our commitment towards expanding access to molnupiravir in India,” MSD-India Region MD Rehan A Khan said. Merck & Co, Inc will also donate more than USD 5 million worth of oxygen-production equipment, masks, hand sanitiser and financial aid to support relief efforts in India, the statement said.