Pfizer has announced it has signed a voluntary license agreement with the Medicines Patent Pool (MPP) involving the drug firm’s oral antiviral drug candidate PF-07321332, administered in combo with low-dose ritonavir. The terms of the agreement empower MPP to facilitate additional production and distribution of the investigational antiviral (pending regulatory authorization or approval) by granting sub-licenses to qualified generic medicine manufacturers; the goal of the pact is increasing equitable access to treatments and vaccines to poorer regions of the planet.
Under the terms of the agreement between the two entities, qualified drug manufacturers who are granted sublicenses will be able to supply the investigational treatment in combination with ritonavir to 95 countries, including all low- and lower-middle-income countries and some upper-middle-income nations in sub-Saharan Africa (and countries that have moved from lower-middle to upper-middle in the past 5 years).
Pfizer will not receive royalties on sales in low-income countries. Further, the pharma firm waives royalties on sales in all countries covered by the agreement as long as COVID-19 remains classified as a Public Health Emergency of International Concern by the World Health Organization (WHO).
“Pfizer remains committed to bringing forth scientific breakthroughs to help end this pandemic for all people. 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,” said Albert Bourla, chairman and CEO 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.”
“This license is so important because, if authorized 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,” commented Charles Gore, MPP 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.”
“Unitaid, a global health agency, created MPP ten years ago for this exact purpose – to secure licenses that enable and accelerate access to affordable quality treatments for people in resource-limited settings,” said Philippe Duneton, executive director of Unitaid. “During a pandemic, saving time means saving lives; this agreement could help us to reach more people more quickly as soon as the medicine is approved and, when coupled with increased access to testing, bring benefits to millions.”
PF-07321332 is an investigational SARS-CoV-2 protease inhibitor antiviral therapy, designed to be administered orally and prescribed at the first sign of infection or first awareness of exposure. The aim is to help patients avoid severe illness, leading to hospitalization and/or death.