Thirty-five generic drug manufacturers will make a more affordable version of Pfizer’s anti-COVID pill for the world’s poorer nations, in licensing deals announced Thursday by a UN-backed organisation.
The global Medicines Patent Pool (MPP) signed agreements with three dozen manufacturers to produce the oral COVID-19 treatment nirmatrelvir for supply in 95 low- and middle-income countries.
US pharmaceutical giant Pfizer signed a licence agreement with the MPP in November. The MPP, in turn, issued sub-licences to the generic drugs makers.
The deals announced Thursday will “help ensure access to our oral COVID-19 treatment for patients in need around the world”, said Pfizer chairman Albert Bourla.
“The MPP sub-licensees and the additional capacity for COVID-19 treatment they will supply will play a critical role to help ensure that people everywhere, particularly those living in the poorest parts of the world, have equitable access to an oral treatment option against COVID-19.”
The sub-licences allow manufacturers to produce the raw ingredients for nirmatrelvir, and/or the finished drug itself co-packaged with the HIV medicine ritonavir.
The 35 companies involved include 19 in India and five in China, the MPP said.
The rest are spread across Bangladesh, Brazil, the Dominican Republic, Jordan, Israel, Mexico, Pakistan, Serbia, South Korea and Vietnam.
A licence has also been offered to a company in Ukraine, which has not yet been able to sign due to Russia’s war in the country.
Six companies will produce the drug substance, nine will produce the drug product and the others will do both.
“Nirmatrelvir is a new product and requires substantial manufacturing capabilities to produce,” said MPP executive director Charles Gore.
Nirmatrelvir is known as a “protease inhibitor” and works by blocking the action of an enzyme the coronavirus needs to replicate. A low dose of ritonavir is administered to slow down the breakdown of nirmatrelvir inside the body.
Because the combination does not target the fast-mutating spike proteins that stud the surface of the coronavirus, it should be more variant-proof than other treatments, such as synthetic antibody infusions, as well as antibodies evoked by most types of COVID vaccine.
The 95 countries covered account for around 53 percent of the world’s population, including all low- and lower-middle-income nations.
Pfizer will not receive royalties from the sub-licensees’ sales of generic nirmatrelvir while COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization.
Following the pandemic, sales to low-income countries will remain royalty-free.
Sales to middle-income countries will be subject to royalties of five percent for the public sector and 10 percent for the private sector.
The Geneva-based MPP is a United Nations-backed international organisation that works to facilitate the development of medicines for low- and middle-income nations.
While the search for vaccines has resulted in multiple products being approved for emergency use in the pandemic, the hunt for treatments for those who have already caught the disease has not been as fruitful.
The medical charity Doctors Without Borders (MSF) said the sub-licensing was a positive step but was concerned by the deal’s limitations, with large countries like Brazil, China, Malaysia and Thailand left out.
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