The United Nations-backed Medicines Patent Pool (MPP) gained access to Pfizer Inc.’s COVID-19 oral antiviral treatment candidate PF-07321332 this week, enabling the organization to produce and distribute the drug to generic sub-licensers for greater global access.
MPP intends to increase access to medicines among low and middle-income countries, which have been especially slighted by COVID-19 treatment supply chains. PF-07321332 does not yet have approval from global agencies, but it — in combination with low dose ritonavir — has demonstrated an 89 percent risk reduction for COVID-19 hospitalizations or death when given to non-hospitalized, high-risk adults within three days of symptom onset, at least according to interim data from the ongoing Phase 2/3 EPIC-HR study.
“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,” Albert Bourla, chairman and CEO of Pfizer, said. “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.”
The new arrangement could — pending regulatory approval or authorization — enable qualified sub-licensees to supply countries that makeup approximately 53 percent of the global population. In all, 95 countries could benefit, while Pfizer would waive royalties on sales in low-income countries and all countries covered by the agreement, so long as 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 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,” Charles Gore, executive director of MPP, said. “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.”
By granting MPP this level of access, it will be able to guarantee additional production and distribution of the antiviral and engage with applications for licensing directly.