The Medicines Patent Pool, a United Nations-based organization that negotiates with companies to increase access to lifesaving medicines in low- and middle-income countries, has signed sublicensing agreements with 35 companies across 12 nations to produce generic versions of Pfizer’s oral antiviral treatment for COVID-19.
The announcement comes four months after MPP signed a voluntary licensing agreement with Pfizer for the drug nirmatrelvir, which is to be taken in combination with ritonavir and is commonly referred to by the brand name Paxlovid. It also follows MPP’s sublicensing agreements with 27 generic drugmakers across 11 countries to manufacture molnupiravir, Merck’s oral antiviral treatment for COVID-19.
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The latest MPP sublicensing agreements are expected to make nirmatrelvir combined with ritonavir available to countries accounting for about 53% of the world population — although it will be limited to the 95 countries that are part of MPP’s voluntary licensing agreement with Pfizer.
The companies are based in Bangladesh, Brazil, China, the Dominican Republic, Jordan, India, Israel, Mexico, Pakistan, Serbia, South Korea, and Vietnam.
A company in Ukraine has also been selected but has been unable to sign on due to the country’s ongoing war with Russia. Speaking with Devex, MPP Executive Director Charles Gore said the organization has given the Ukrainian company an “indefinite extension” to accept the license, given the circumstances.
The companies were selected based on their demonstrated ability to “meet MPP’s requirements related to production capacity, regulatory compliance, as well as international standards for quality-assured medicines,” according to a press release. Gore told Devex that part of the selection process for the sublicensing agreements was also ensuring that the companies are able to get ritonavir, either by producing it themselves — it’s off-patent — or from a reliable source.
The agreements were signed at a time when a number of high- and middle-income countries are easing pandemic restrictions and moving toward the idea of COVID-19 endemicity. But with variants like omicron continuing to circulate and cause surges in different countries, and billions still unvaccinated — only 14.1% of the people in low-income countries have received at least one vaccine dose — having available treatments, and not just vaccines, is growing in importance.
“I think that a lot of the assumption was that omicron was kind of mild, but that's only the case in [vaccinated] people, it now turns out. And one of the things we don't know is how long even boosters last. So having treatments that are affordable and available is critically important,” Gore said.
Pfizer’s oral antiviral treatment for COVID-19 made headlines late last year after the company said it was able to reduce a patient’s risk of hospitalization or death by 89%. But to be effective, the treatment needs to be given within five days of symptoms appearing. That means patients need to have access to testing and get tested immediately to be able to access the drug. Civil society organizations have been pushing for a test-and-treat strategy in line with this, including self-testing, but it’s been largely unavailable in many low-income countries.
35 companies, but none in Africa
Out of the 35 companies selected, six will be producing the drug substance for nirmatrelvir, while nine will focus on taking that substance and turning it into a finished product. The remaining 20 companies will do both.
The companies are geographically spread out, but what’s missing are any companies in Africa.
“I'm personally very disappointed that there are none in Africa, particularly given the work that we're doing around vaccines in Africa,” Gore said.
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“This is one of our worries: that not enough companies apply from Africa. And we did in fact offer a license to two African companies, but for a variety of reasons … we were not able to take this forward. So I can't go into the details of that, but it’s just unfortunate,” he said.
He said he doesn’t think that will have an impact in terms of access to the treatment on the continent.
“We think we've got enough suppliers all over the world to make sure they can supply Africa,” Gore said.
But he underscored the importance of supporting not just vaccine manufacturing, but manufacturing for therapeutics in Africa.
“There are a lot of generic companies in Africa, but often they're only producing for their internal market. They're not really able at the moment to reach the quality standards that we require,” he said.
“And you know, that's a worry, because it suggests that maybe in Africa certain countries are getting substandard drugs,” Gore continued. “So we really want some funding and support for companies to reach the kind of threshold that we need that will make them more confident about applying for our licenses, and it'll make it much easier for us to give them licenses.”
No price yet
Sales of the treatment will be royalty-free so long as COVID-19 remains a “public health emergency of international concern,” a designation by the World Health Organization. Once this designation ends, sales to low-income countries will remain royalty-free, while sales to upper- and lower-middle-income countries will be subject to a 5% and 10% royalty based on sales to the public and the private sectors, respectively.
It’s unknown how much the generics of Pfizer’s oral COVID-19 treatment will cost. Gore said it might be “a bit more expensive than molnupiravir,” given that nirmatrelvir is a more complex molecule.
“But I don't think it's going to be hugely more expensive. … It's not going to be hundreds of dollars at all,” he said.
Current cost estimates for a full course of molnupiravir are around $20 to $25, but Gore said this might go down even further, to around $10.
Under the licensing agreement, the generic manufacturers can supply nirmatrelvir combined with ritonavir in 95 low- and middle-income countries. But that still leaves out several middle-income countries, including a number in Latin America, which could face challenges in accessing supplies of the drug from Pfizer. According to some estimates, many of the treatment courses that Pfizer is expected to produce during the first half of 2022 have already been purchased — and almost entirely by high-income countries.
But even the 95 low- and middle-income countries covered by MPP’s licensing will have to wait to gain access to the generics. Gore said there’s an “inevitable lag” between getting the license and having the product out in the market in low- and middle-income countries. And for this one, it could be available at the end of 2022 or early 2023, he said. That’s already a shorter timeline, given that it normally takes three years from receiving a license to getting a product out.
“This is something that we're hoping that Pfizer is able to at least contribute towards,” Gore said, adding that MPP is in discussions with the company on what ways it can speed up the process of getting the medicines out in the market.
“They have offered a tech pack to help … [generic drugmakers] develop it. So I think they're absolutely as committed to getting this out through the generics as much as we are or the generics are,” Gore said.
About the author
Jenny Lei Ravelo@JennyLeiRavelo
Jenny Lei Ravelo is a Devex Senior Reporter based in Manila. She covers global health, with a particular focus on the World Health Organization, and other development and humanitarian aid trends in Asia Pacific. Prior to Devex, she wrote for ABS-CBN, one of the largest broadcasting networks in the Philippines, and was a copy editor for various international scientific journals. She received her journalism degree from the University of Santo Tomas.
