Generic manufacturers to produce COVID-19 treatment nirmatrelvir
Posted: 18 March 2022 | Hannah Balfour (European Pharmaceutical Review) | No comments yet
Pfizer’s oral COVID-19 treatment nirmatrelvir will be produced by 35 generic manufacturers to increase supply for low- and middle-income countries.
More than 30 companies have signed agreements with the Medicines Patent Pool (MPP) to manufacture the generic version of Pfizer’s oral COVID-19 treatment nirmatrelvir. In combination with a low dose of ritonavir, nirmatrelvir will 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 percent 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.
The 35 companies span 12 countries, namely 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.
Six companies will focus on producing the drug substance, nine companies will produce the drug product and the remaining 20 will do both.
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 five percent royalty for sales to the public sector and a 10 percent 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,” stated 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,” stated 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.”
When taken in combination, the branded version of nirmatrelvir and ritonavir is known as Paxlovid™. While not formally approved, the European Medicines Agency (EMA) has said it may be used to treat adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease.
Drug Manufacturing, Drug Supply Chain, Generics, Therapeutics