35 generic manufacturers sign agreements with MPP to produce low-cost, generic versions of Pfizer’s oral COVID-19 treatment nirmatrelvir in combination with ritonavir for supply in 95 low- and middle-income countries
17 March 2022
Geneva – The Medicines Patent Pool (MPP) announced today that it 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 sublicences 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.
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 licence has also 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 sublicences 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,” said Charles Gore, MPP Executive Director. “Furthermore, 15 companies are signing their first licence with MPP, and we warmly welcome our new generic manufacturing partners.”
“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, said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “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.”
Update – 22 March: Ukrainian company Darnitsa signs sublicence agreement with MPP bringing to 36 the number of generic manufacturers to produce generic versions of Pfizer’s oral COVID-19 treatment
The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to, and facilitate the development of, life-saving medicines for low- and middle-income countries. Through its innovative business model, MPP partners with civil society, governments, international organisations, industry, patient groups, and other stakeholders, to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, MPP has signed agreements with 13 patent holders for thirteen HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, two long-acting technologies, two experimental oral antiviral treatments for COVID-19 and a COVID-19 serological antibody diagnostic test. MPP was founded by Unitaid, which continues to be MPP’s main funder. MPP’s work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC). MPP’s activities in COVID-19 are undertaken with the financial support of the Japanese Government and SDC. More information at https://medicinespatentpool.org/ and follow us on Twitter, LinkedIn and YouTube.