The Medicines Patent Pool has signed agreements with 35 companies to manufacture the generic version of Pfizer’s oral COVID-19 treatment nirmatrelvir, which in combination with a low dose of ritonavir can be supplied in 95 low- and middle-income countries.
The sublicence agreements are the result of the voluntary licensing agreement signed by MPP and Pfizer in November 2021 that will help enable the supply of the medicines to countries comprising approximately 53% of the world’s population.
The non-exclusive sublicenses allow generic manufacturers to produce the raw ingredients for nirmatrelvir and/or the finished drug itself co-packaged with ritonavir. The companies that were offered the sublicence demonstrated their ability to meet MPP’s requirements related to production capacity, regulatory compliance, as well as international standards for quality-assured medicines.
“We have established a comprehensive strategy in partnership with worldwide governments, international global health leaders and global manufacturers to help ensure access to our oral COVID-19 treatment for patients in need around the world,” Albert Bourla, chairman and CEO of Pfizer, said. “The MPP sublicensees 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.”
Six companies will focus on producing the drug substance, nine companies will produce the drug product and the remainder will do both. The companies span 12 countries — Bangladesh, Brazil, China, Dominican Republic, Jordan, India, Israel, Mexico, Pakistan, Serbia, Republic of Korea and Vietnam. A license also has been offered to a company in Ukraine, the offer will remain available to them as they are not able to sign due to the current conflict.
While Pfizer negotiated an agreement with MPP that establishes the terms and conditions, the requests for sublicenses from generic producers were reviewed by MPP and presented to Pfizer. Pfizer will not receive royalties from sales of nirmatrelvir from the MPP sublicensees while COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization. Following the pandemic period, sales to low-income countries will remain royalty-free, lower-middle-income countries and upper-middle-income countries will be subject to a 5% royalty for sales to the public sector and a 10% royalty for sales to the private sector.
“Nirmatrelvir is a new product and requires substantial manufacturing capabilities to produce, and we have been very impressed with the quality of manufacturing demonstrated by these companies,” Charles Gore, MPP executive director, said. “Furthermore, 15 companies are signing their first license with MPP, and we warmly welcome our new generic manufacturing partners.”