Promising Covid-19 Pill Licensed to Nonprofit to Increase Global Supply

How many pills will be produced under the licensing deal once manufacturers’ plants are fully operational is unclear, MPP said, though it predicts some manufacturers will be able to start deliveries this year.

Merck, which developed the drug with Ridgeback Biotherapeutics LP, has said it can manufacture 10 million courses by the end of the year, and is increasing capabilities to make more next year.

“From the beginning we knew we wanted to expand the geographic footprint of our generic partners,” said Paul Schaper, Merck’s executive director of global pharmaceutical public policy. He said Merck’s supply agreements and licensing deals will provide “global access in high-income and low- and-middle income countries at the same time.”

Molnupiravir promises to be the first pill that people infected with Covid-19 could take at home to prevent hospitalization, which would fill a huge gap, including in countries where people lack easy access to basic healthcare.

Wealthy countries, such as Australia and South Korea, have also been waiting for such a drug and have begun reaching supply deals with Merck. The U.S., for instance, has agreed to pay $1.2 billion for 1.7 billion courses, should regulators clear it for use.

The licensing deal is the latest effort designed to avoid the kind of rich-poor split in access that has marked the Covid-19 vaccine rollout, sparking criticism. Many of the countries covered by the licensing deal have limited Covid-19 vaccine supplies.

“Vaccines have been the standout case where people say, ‘This isn’t fair with what’s happening,’” said MPP Executive Director Charles Gore. “This is now a step to correcting some of that.”

Merck previously licensed production of molnupiravir to generic drugmakers in India including Dr. Reddy’s Laboratories Ltd. and Sun Pharmaceutical Industries Ltd.

The Bill & Melinda Gates Foundation recently pledged up to $120 million to accelerate manufacturing of generic forms of molnupiravir for lower-income countries.

Altogether, the deals mean Merck would end up making molnupiravir largely for wealthier countries, while smaller drugmakers will produce the bulk of pills for low- and middle-income countries.

Molnupiravir promises to be a long-awaited addition to the Covid-19 medicine chest.

While drugs such as a steroid named dexamethasone and the antiviral remdesivir have been found to reduce the length of hospitalization, only antibody drugs have been shown to help keep people out of the hospital.

Yet the antibody drugs must be given by intravenous infusion at a doctor’s office, hospital or medical clinic, and they have been in short supply in many countries.

Merck and Ridgeback asked the U.S. Food and Drug Administration to authorize the pill this month, after a late-stage study showed it cut the risk of hospitalization or death by about 50% in high-risk people with mild to moderate Covid-19.

Under the licensing deal, Merck, Ridgeback and Emory University—where researchers invented the drug—will forgo royalties.

Generic companies will ask MPP for permission to produce molnupiravir, with MPP selecting multiple manufacturers that would strike supply deals with countries, Mr. Gore said.

About 50 companies have informally expressed interest in producing the drug so far, Mr. Gore said. He declined to name them.

Competition among the manufacturers is expected to make the pill affordable. Research suggests that such a licensing arrangement could reduce the cost of molnupiravir to less than $20 a course of treatment, Mr. Gore said.

Increasing manufacturing shouldn’t be difficult because molnupiravir is a small molecule, which companies have made for years, Mr. Gore said.

The Gates funding will help manufacturers implement a simplified medicine-making process and gather data to apply for regulatory approvals, said Trevor Mundel, the foundation’s president of global health.

The foundation worked with chemists to simplify molnupiravir’s manufacturing process to two steps from about a dozen, Dr. Mundel said.

Some larger generics manufacturers could produce each month as many as 10 million treatment courses, meaning 40 capsules of 200 milligrams each, Dr. Mundel said.

The funding, he said, could “provide some kind of bridge and to get everybody to the state of using the simplest synthesis and getting the most affordable quality product out there.”

Write to Jared S. Hopkins at [email protected] and Betsy McKay at [email protected]