Merck will share formula for its Covid pill with poor countries
Merck has granted a royalty-free license to a UN-backed nonprofit for its promising Covid-19 pill that will allow the drug to be made and sold cheaply in the poorest countries, where coronavirus vaccines are devastating. are less. supply.
The agreement with Medicines Patent Pool, an organization that works to make medical treatments and technologies globally accessible, will allow companies in 105 countries, mostly in Africa and Asia, to sublicense formulations for the antiviral pill, called mollupiravir, and will start making it. .
Merck reported this month that the drug halved the rate of hospitalization and death in high-risk Covid patients in a large clinical trial. Rich nations, including the United States, have rushed to negotiate deals to buy the drug, tying up large chunks of supply before it can be approved by regulators and raising concerns that poor countries may be out of access to the drug. will go on, much as they have been done for vaccines.
Treatment-access advocates welcomed the new deal, which was announced Wednesday morning, calling it an unusual move for a major Western pharmaceutical company.
“The Merck license is a very good and worthwhile protection for people living in countries where more than half the world’s population lives,” said James Love, who leads Knowledge Ecology International, a non-profit research organization. “It will make a difference.”
Charles Gore, director of the Medicines Patent Pool, said: “This is the first transparent public health license for a Covid drug, and what’s really important is that it’s for something that can be used outside of hospitals, and which Potentially going to be very cheap.”
“It’s going to hopefully make things a lot easier in terms of keeping people out of hospital and preventing people dying in low- and middle-income countries,” he said.
Mr. Gore said more than 50 companies from all regions of the developing world have already approached the organization to obtain sub-licenses.
The agreement with Merck, Mr. Gore said, is also critically important as a precedent. “I expect this to start a landslide of people coming into the medicine patent pool of people wanting to do the licensing, because there’s no question that access has been a problem,” he said. “From a scientific point of view, the industry has done a really great job – first, providing vaccines, and now providing treatments. But the access side of it has clouded the whole thing.”
Pfizer also has a Covid antiviral pill in late-stage trials, and Mr Gore said the company is also in talks with the patent pool.
Updates
October 27, 2021, 5:03 am ET
Molnupiravir was developed by Merck and Ridgeback Biotherapeutics of Miami, based on a molecule previously studied at Emory University in Atlanta. All three organizations are parties to the deal, which will not require a fee from any sub-licensing company.
Merck has submitted its clinical trial data to the Food and Drug Administration seeking emergency use authorization; The decision could come in early December. Regulatory agencies in other countries that produce a version of mollupiravir will need to evaluate it. Some drugmakers will seek World Health Organization pre-qualification for their versions, so that they can bypass country-by-country regulatory steps.
Stephen Saad, chief executive officer of Aspen Pharmacare in South Africa, said his company hopes to apply for a license to manufacture molnupiravir and distribute it across Africa. He said he believes Aspen can make the drug for about $20 per course. The US government has an agreement to buy 1.7 million courses of the drug, pending its authorization by the FDA, a deal that fixes the price at $712 per course.
Mr Gore said he has been told by some in the field that a generic version of mollupiravir can be produced profitably for as little as $8 per course.
Under the licensing deal, Merck will continue to produce and sell the drug at significantly higher prices to wealthy countries and many middle-income people.
Merck had already taken the move to license eight major Indian drugmakers to produce generic versions of molnupiravir, pending authorisation. But the company feared that production in just one region would not be enough to ensure rapid access to the drug in the developing world, said Janelle Krishnamurthy, Merck’s vice president of global policy.
So the company is also negotiating with a patent pool that has deep experience working with a network of global drug manufacturers that can meet high quality standards, including those required for WHO prequalification, he said. said.
“We knew we had to work faster, we had to do things we hadn’t done before, we were more efficient,” Ms Krishnamurthy said.
Merck’s licenses to Indian generic manufacturers that restrict sales to developing countries and exclude most middle-income people, including China and Russia – the site of a current raging Covid outbreak – raise the possibility. Citizens in these countries, who often have weak health systems, will not have access to medicine.
Middle-income countries and most countries in Latin America are also not covered in the patent pool agreement for molnupiravir, Mr. Love said.
“What are you going to do to countries like Chile or Colombia, Thailand or Mexico?” He asked. “They’re not under license.”
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