To address the intensifying COVID-19 crisis in India, the pharmaceutical company Merck has agreed to facilitate the manufacture and distribution of molnupiravir, an investigational antiviral drug that was discovered at Emory.
“To advance a drug quickly and across the globe in all the countries where it is needed, you need the capacity of a company like Merck,” said George Painter, PhD, CEO of the non-profit Emory-owned DRIVE (Drug Innovation Ventures at Emory), at a media briefing Tuesday. “It’s gratifying to see how quickly they moved and how they’re getting this into the hands of people in India to meet this threat.”
Over the last several days, India has been reporting world records for daily COVID-19 case counts, and has asked for aid from other countries to supply oxygen and medical equipment, as well as antiviral drugs.
Molnupiravir, previously known as EIDD-2801, was initially developed by DRIVE as a broad-spectrum antiviral against equine encephalitis and influenza, but laboratory tests showed it was also active against coronaviruses. Molnupiravir was licensed to Merck through its partner Ridgeback Biotherapeutics last year, and Merck is currently conducting Phase III clinical trials of the drug in the United States.
In Phase II clinical trial results reported in March, molnupiravir could eliminate infectious SARS-CoV-2 from the nose swabs of non-hospitalized symptomatic COVID-19 patients within five days. The drug can be delivered as a pill in an outpatient setting, and would be more convenient to distribute than current antiviral drugs such as remdesivir, which must be given by injection or intravenously.
Merck announced Tuesday that the company has entered into licensing agreements for molnupiravir with five Indian generic manufacturers. These agreements will speed up availability of the drug in India and other countries, following potential approvals or emergency authorization by their regulatory agencies.
According to Merck, agreements have been signed with Cipla Limited, Dr. Reddy’s Laboratories Limited, Emcure Pharmaceuticals Limited, Hetero Labs Limited and Sun Pharmaceutical Industries Limited, which all have World Health Organization pre-qualified manufacturing facilities.
“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,” Merck’s chairman and CEO, Kenneth C. Frazier, said in a statement.
Painter said that the humanitarian emergency currently unfolding in India is exactly the situation that DRIVE was originally set up to meet.
“My hope is that the drug is able to reduce transmission, and lower the burden on an already overburdened health care system,” he said.
The drug is likely to be more effective when administered at early stages of infection, researchers think. More guidance on how to distribute and use molnupiravir will emerge from current Phase III studies, Painter said.