35 generic manufacturers sign agreements with MPP to produce generic versions of Pfizer’s nirmatrelvir

The Medicines Patent Pool (MPP) announced recently that it has signed agreements with 35 companies, including Cadila Pharma, Torrent Pharma, Aurobindo Pharma, MSN Group, SMS Pharma, Granules India, 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 (LMICs).

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 per cent of the world’s population, MPP said in a statement.

It also said that 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 remaining ones 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, the statement noted.

The statement further mentioned that 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 (WHO). Following the pandemic period, sales to low-income countries will remain royalty free, LMICs and upper-middle-income countries will be subject to a five per cent royalty for sales to the public sector and a 10 per cent royalty for sales to the private sector.

“Nirmatrelvir is a new product and requires substantial manufacturing capabilities to produce, and we have been impressed with the quality of manufacturing demonstrated by these companies. Furthermore, 15 companies are signing their first licence with MPP, and we warmly welcome our new generic manufacturing partners, said Charles Gore, Executive Director, MPP.