Merck’s Covid-19 pill licensed to UN-backed nonprofit to boost global supplies – .

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Merck’s Covid-19 pill licensed to UN-backed nonprofit to boost global supplies – .



The Medicines Patent Pool, which aims to expand poor countries’ access to medicines, will work with several drug manufacturers to produce molnupiravir for 105 countries, including Pakistan, Cambodia and all of Africa, the company said on Wednesday and the non-profit association.

It is not clear how many pills will be produced under the license agreement once the manufacturers’ factories are fully operational, MPP said, although it predicts that some manufacturers may start shipments this year. .
Merck, which developed the drug with Ridgeback Biotherapeutics LP, said it could manufacture 10 million courses by the end of the year and would increase capacity to do more next year.

“From the start, we knew we wanted to expand the geographic footprint of our generic partners,” said Paul Schaper, executive director of global pharmaceutical public policy at Merck. He said Merck’s supply and license agreements will provide “global access in high 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 avoid hospitalization, which would fill a huge void, including in countries where people do not have easy access to basic health care.

Rich countries like Australia and South Korea are also waiting for such a drug and have started to make supply deals with Merck. The United States, for example, has agreed to pay $ 1.2 billion for 1.7 million courses, if regulators allow their use.

The licensing deal is the latest effort designed to avoid the kind of divide between rich and poor in access that has marked the deployment of the Covid-19 vaccine, drawing criticism. Many countries covered by the license agreement have limited supplies of Covid-19 vaccines.

“Vaccines have been the remarkable case where people say, ‘It’s not fair with what’s going on,’” MPP CEO Charles Gore said. “Now is a step to correct some of that. “

Merck previously cleared the production of molnupiravir to generic drug manufacturers in India, including Dr Reddy’s labs Ltd.

and Sun Pharmaceutical Industries Ltd.

Molnupiravir promises to be the first pill that people infected with Covid-19 could take at home to avoid hospitalization.

Photo:
Merck

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

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

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

Although drugs such as a steroid called dexamethasone and the antiviral remdesivir have been shown to reduce the length of hospital stays, only antibody-based drugs have been shown to help keep people out of hospital.

However, antibody-based drugs must be given by intravenous infusion in a doctor’s office, hospital or clinic, and they are rare in many countries.

Doctors are increasingly turning to monoclonal antibody drugs to treat high-risk patients who become ill with Covid-19. The WSJ examines how therapies work and why they are important in saving lives. Illustration: Jacob Reynolds / WSJ

Merck and Ridgeback asked the U.S. Food and Drug Administration to clear the pill this month, after an advanced study found it reduced the risk of hospitalization or death in ” about 50% in high-risk people with mild to moderate Covid-19.

Under the license agreement, Merck, Ridgeback and Emory University, where the researchers invented the drug, will waive the royalties.

Generic manufacturers will apply to the MPP for permission to produce molnupiravir, with the MPP selecting several manufacturers who would enter into supply agreements with countries, Gore said.

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

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Competition among manufacturers should make the pill affordable. Research suggests that such a licensing agreement could reduce the cost of molnupiravir to less than $ 20 per treatment, Gore said.

Increasing manufacturing shouldn’t be difficult because molnupiravir is a small molecule that companies have been making for years, Gore said.

Gates funding will help manufacturers implement a streamlined drug manufacturing process and collect data to apply for regulatory approvals, said Trevor Mundel, chairman of the Global Health Foundation.

The foundation worked with chemists to simplify the two-step molnupiravir manufacturing process against a dozen, Dr. Mundel said.

Some large generics companies could produce up to 10 million treatments per month, or 40 capsules of 200 milligrams each, said Dr Mundel.

The funding, he said, could “provide a kind of bridge and get everyone to use the simplest synthesis and get the most affordable quality product.”

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

Corrections et amplifications
The United States has agreed to purchase 1.7 million experimental cures of molnupiravir, the Covid-19 pill. An earlier version of this article incorrectly stated that the deal was for 1.7 billion courses. (Corrected October 27)

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