Pfizer has signed an agreement with the Medicines Patent Pool (MPP) that will allow generic versions of its oral antiviral drug against COVID-19 in 95 countries, about 53% of the world’s population (all low- and lower-middle income and some upper-middle income from sub-Saharan Africa, as well as those who have moved from lower-middle to upper-middle income in the last five years).
As announced by Pfizer in a statement, the agreement will allow MPP to facilitate the additional production and distribution of the investigational antiviral, pending authorization or regulatory approval, by granting sub-licenses to qualified generic drug manufacturers, with the aim of facilitating greater access to the world’s population.
‘Paxlovid’ (PF-07321332) is an investigational SARS-CoV-2 protease inhibitor antiviral treatment specifically designed to be administered orally, so that it can be prescribed at the first sign of infection or upon becoming aware of an exposure, which could help patients avoid a serious illness that can lead to hospitalization and death.
It is designed to block the protease activity of SARS-CoV-2-3CL, an enzyme that the coronavirus needs to replicate. Coadministration with a low dose of ritonavir helps to slow the metabolism, or breakdown, of PF-07321332 so that it remains active in the body longer in higher concentrations to help fight the virus.
According to an interim analysis of the phase 2/3 ‘EPIC-HR’ randomized, double-blind study, the antiviral showed an 89% reduction in the risk of hospitalization or death for any COVID-19-related cause compared to placebo in patients treated within three days of symptom onset.
Pfizer will not receive royalties for sales in low-income countries and will also waive those for sales in all countries covered by the agreement as long as COVID-19 remains classified as a Public Health Emergency of International Interest by the World Organization. of Health (WHO).
“Pfizer remains committed to bringing scientific breakthroughs that help end this pandemic for all people. We believe that oral antiviral treatments can play a critical role in reducing the severity of COVID-19 infections, easing the pressure on our healthcare systems and saving lives.
We must work to ensure that all people, regardless of where they live or their circumstances, have access to these advancements, and we are pleased to be able to work with MPP to further our commitment to fairness, “said Pfizer President and CEO. , Albert Bourla.
“This license is so important because, if it is authorized or approved, this oral medicine is especially suitable for low- and middle-income countries and it could play a critical role in saving lives, contributing to global efforts to fight the current pandemic.
PF-07321332 will be taken together with ritonavir, a well-known HIV medicine, since we have a license on it for many years, and we will work with generic companies to ensure that there is a sufficient supply for both COVID-19 and HIV, “added MPP Executive Director Charles Gore.