PremiumPharma company MSD on Tuesday said that it 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.
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.
The drug firm will also donate more than $5 million worth of oxygen-production equipment, masks, hand sanitiser and financial aid to support relief efforts in India, the statement said.
MSD India is a wholly-owned subsidiary of Merck Sharp & Dohme (MSD) and known as Merck & Co., Inc, in the United States and Canada.
"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 in a statement.
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.
"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.
Meanwhile, Natco Pharma has already applied to India's CDSCO to conduct Phase 3 trials of Molnupiravir.
"Natco Pharma has applied to the Central Drugs Standard Control Organization (CDSCO) in India for approval of phase-III clinical trial of Molnupiravir capsules for the treatment of COVID-19 positive patients," the company said in a regulatory filing.
Natco Pharma said pre-clinical data have shown that Molnupiravir has broad anti-influenza activity, including highly potent inhibition of SARS-CoV-2 replication.
Natco is hoping that CDSCO would give emergency approval of this drug based on “compassionate use" for patients.
“Compassionate use" approval is given for investigational drugs so a patient with an immediately life-threatening condition can gain access to the drug, Natco Pharma said, adding that the company is ready to launch the product this month if approval is given.
