EuropeanPharmaceuticalReviewNovember 18, 2021
Pfizer and the Medicines Patent Pool (MPP), a United Nations (UN)-backed public health organisation, have announced the signing of a voluntary license agreement for Pfizer’s COVID-19 oral antiviral treatment candidate PF-07321332, which is administered in combination with low dose ritonavir.
The agreement will enable the MPP to facilitate additional production and distribution of the investigational antiviral, pending regulatory authorisation or approval, by granting sub-licenses to qualified generic medicine manufacturers, with the goal of facilitating greater access to the global population.
Under the terms of the head license agreement between Pfizer and MPP, qualified generic medicine manufacturers worldwide that are granted sub-licenses will be able to supply PF-07321332 in combination with ritonavir to 95 countries, covering up to approximately 53 percent of the world’s population. According to Pfizer, this includes all low- and lower-middle-income countries and some upper-middle-income countries in Sub-Saharan Africa as well as countries that have transitioned from lower-middle to upper-middle-income status in the past five years.
Pfizer will not receive royalties on sales in low-income countries and will further waive royalties on sales in all countries covered by the agreement while COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization (WHO).
“This license is so important because, if authorised or approved, this oral drug is particularly well-suited for low- and middle-income countries and could play a critical role in saving lives, contributing to global efforts to fight the current pandemic,” stated Charles Gore, Executive Director of MPP. “PF-07321332 is to be taken together with ritonavir, an HIV medicine we know well, as we have had a license on it for many years, and we will be working with generic companies to ensure there is enough supply for both COVID-19 and HIV.”
We believe oral antiviral treatments can play a vital role in reducing the severity of COVID-19 infections, decreasing the strain on our healthcare systems and saving lives,” added Albert Bourla, Chairman and Chief Executive Officer of Pfizer. “We must work to ensure that all people – regardless of where they live or their circumstances – have access to these breakthroughs, and we are pleased to be able to work with MPP to further our commitment to equity.”
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