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Merck has granted a royalty-free license to a United Nations-backed nonprofit for its promising Covid-19 pill, in an agreement that would allow the drug to be manufactured and sold cheaply in the poorest countries where coronavirus vaccines are devastatingly short. supply.
The agreement with the Pharmaceutical Patent Pool, an organization working to make medical treatments and technologies accessible globally, will allow companies in 105 countries, mostly in Africa and Asia, to sublicense and begin manufacturing the formulation of the antiviral pill called molnupiravir. .
Merck reported this month that in a large clinical trial, the drug has halved the rate of hospitalization and death in high-risk Covid patients. Wealthy countries, including the United States, rushed to strike deals to buy the drug, tying up a large portion of the supply before it was even approved by regulators, raising concerns that poor countries’ access to the drug would be shut down too much. as for vaccines.
Access to treatment advocates welcomed the new deal, announced Wednesday morning, as an unusual move for a major Western pharmaceutical company.
“The Merck license is a very good and meaningful protection for people living in countries where more than half the world’s population lives,” said James Love, who runs Knowledge Ecology International, a nonprofit research organization. “This will make the difference.”
Charles Gore, director of the Pharmaceutical Patent Pool, said: “This is the first transparent public health license for a Covid drug, and really more importantly, for something that can be used outside of hospitals and potentially a lot. cheap.”
“This will hopefully make things a lot easier in terms of keeping people out of the hospital and stopping 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 applied to the organization for sub-licensing.
Mr. Gore said the deal with Merck was also critical as a precedent. “Hopefully this starts a landslide for people who come to the Pharmaceutical Patent Pool and want to get a license, because there is no doubt that the problem is access,” he said. “From a scientific point of view, the industry has done a really great job – first providing the vaccines and now providing the treatments. But the access side has disappointed everything.”
Pfizer also has a Covid antiviral pill in late-stage trials, and Mr Gore said it is also in talks with the company’s patent pool.
Molnupiravir was developed by Merck and Ridgeback Biotherapeutics of Miami based on a molecule first studied at Emory University in Atlanta. All three organizations are parties to this agreement and will not charge any sub-licensing company fees.
Merck has submitted clinical trial data to the Food and Drug Administration. request an emergency use permit; A decision may come in early December. Regulators in other countries producing a version of molnupiravir will need to consider this. Some drug manufacturers will likely require World Health Organization prequalification for their releases so they can bypass regulatory steps by country.
Stephen Saad, CEO of Aspen Pharmacare in South Africa, said his company expects to apply for a license to make molnupiravir and distribute it in Africa. He said he believes Aspen can make the drug for about $20 per course. The US government has an agreement to purchase 1.7 million drug courses pending approval by the FDA, a deal that fixes the price at $712 per course.
Mr Gore said he was told by some in the field that a generic version of molnupiravir could be produced profitably for as little as $8 per course.
Under the licensing agreement, Merck would continue to manufacture and sell the drug in wealthy countries and many middle-income countries at significantly higher prices.
Merck had already stepped in licensing eight major Indian pharmaceutical manufacturers producing generic versions of molnupiravir pending authorization. But Jenelle Krishnamoorthy, Merck’s vice president of global policy, said the company fears that production in just one region will not be enough to ensure rapid access to medicine in the developing world.
That’s why the company said it’s also in talks with the patent pool, which has deep experience working with a global network of pharmaceutical manufacturers that can meet high quality standards, including those required for WHO prequalification.
“We knew we had to work faster, we had to do things we hadn’t done before, we had to be more efficient,” said Ms. Krishnamoorthy.
Merck’s licenses to Indian generics manufacturers restrict sales to developing countries and exclude most middle-income people, including China and Russia, where the current severe COVID-19 outbreak is. healthcare systems will not be able to access medicine.
Mr. Love said that the patent pool agreement for molnupiravir also does not cover middle-income countries and most countries in Latin America.
“What will you do for countries like Chile, Colombia, Thailand or Mexico?” He asked. “They’re not on the license.”
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