Merck has granted a royalty-free license for its promising Covid-19 pill to a United Nations-backed nonprofit in a deal that would allow the drug to be manufactured and sold cheaply in countries the poorest, where coronavirus vaccines are extremely short. supply.
The deal with the Medicines Patent Pool, an organization that works to make medical treatments and technologies accessible globally, will allow companies in 105 countries, mostly in Africa and Asia, to sublicense the formulation of the antiviral pill, called molnupiravir, and start making it. .
Merck reported this month that the drug had halved the rate of hospitalizations and deaths among patients at high risk of Covid in a large clinical trial. Rich countries, including the United States, have rushed to negotiate deals to buy the drug, locking up much of the supply even before it was approved by regulators and raising concerns that countries poor people are deprived of access to medicine, much as they have been to vaccines.
Treatment access advocates hailed the new deal, which was announced Wednesday morning, calling it an unusual step for a major Western pharmaceutical company.
âThe Merck license is very good and meaningful protection for people living in countries where more than half of the world’s population lives,â said James Love, who heads Knowledge Ecology International, a non-profit research organization. âIt will make a difference. “
Charles Gore, Director of the Medicines Patent Pool, said: âThis is the first transparent public health license for a Covid drug, and very important, it is for something that could be used outside of hospitals, and which is potentially going to be very cheap. “
âThis will hopefully make things a lot easier by preventing people from going to hospitals and preventing people from dying in low- and middle-income countries,â he said.
Mr Gore said more than 50 companies, from all parts of the developing world, have already approached the organization for a sublicense.
The deal with Merck, Gore said, is also a critically important precedent. âHopefully this will trigger a landslide of people coming into the Medicines Patent Pool, wanting to license, because there is no doubt that access has been the problem,â he said. âFrom a scientific standpoint, the industry has done a really brilliant job – first providing the vaccines, and now providing the treatments. But the access side dropped everything. “
Pfizer also has a Covid antiviral pill in late stage trials, and Mr Gore said the company is in talks with the patent pool as well.
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, which will not require any fees from any sublicensing company.
Merck has submitted its clinical trial data to the Food and Drug Administration to apply for emergency use authorization; a decision could be made in early December. Regulators in other countries that produce a version of molnupiravir will need to evaluate it. Some drugmakers will likely seek World Health Organization prequalification for their versions, so they can bypass regulatory steps country by country.
Stephen Saad, managing director of Aspen Pharmacare in South Africa, said his company plans to apply for a license to make molnupiravir and distribute it across Africa. He said he believed Aspen could make the drug for around $ 20 per course. The US government has an agreement to purchase 1.7 million courses of the drug, pending FDA clearance, an agreement that fixes the price at $ 712 per course.
Mr Gore said some in the field told him that a generic version of molnupiravir could be produced cost-effectively for as little as $ 8 per course.
As part of the licensing deal, Merck would continue to produce and sell the drug in wealthy countries and many middle-income countries at significantly higher prices.
Merck had already taken the initiative to allow eight major Indian drugmakers to produce generic versions of molnupiravir, pending clearance. But the company feared that production in a single region would not be sufficient to ensure rapid access to the drug in developing countries, said Jenelle Krishnamoorthy, Merck’s vice president for global policy.
The company has therefore also entered into talks with the patent pool, which has extensive experience working with a global network of drug manufacturers capable of meeting high quality standards, including those required for WHO prequalification. , she said.
“We knew we had to work faster, we had to do things that we had never done before, we had to be more efficient,” said Ms Krishnamoorthy.
The licenses Merck has issued to Indian generics manufacturers restrict sales to developing countries and exclude most middle-income countries, including China and Russia – the site of a current raging Covid epidemic – raising the possibility that the citizens of these countries, which often have weak health systems, will not have access to the drug.
The molnupiravir patent pool deal also excludes middle-income countries and most Latin American countries, Love said.
âWhat are you going to do for countries like Chile or Colombia, Thailand or Mexico? ” He asked. “They are not in the license.”