Pfizer deal allows generic versions of COVID pill for low-income countries

pharmafile | November 17, 2021 | News story | Research and Development  

Pfizer has announced a deal for the production of its antiviral Paxlovid pill to generic drug manufactures, for supply in 95 low- and middle-income nations, covering around 53% of the world’s population. The deal, struck with the global Medicines Patent Pool (MPP), allows for a cheaper treatment option for some of the world’s least-wealthy countries. Paxlovid is intended for COVID-19 patients who are at a higher hospitalization or mortality risk.

In combination with low-dose ritonavir, the inhibitor of the main protease of SARS-CoV-2 prevented hospitalisation in 89% and death in 100% of symptomatic COVID-19 patients in a Phase III clinical trial. By inhibiting protease activity, Paxlovid works to hinder virus replication.

The agreement is subject to the oral antiviral medication passing ongoing trials and regulatory approval. While COVID remains classified a Public Health Emergency of International Concern by WHO, Pfizer will not receive royalties on sales in all countries covered by the agreement.

“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,” said Charles Gore, Executive Director of MPP.

Separately, Pfizer has also shared that it is seeing Emergency Use Authorisation (EUA) from the FDA for the COVID pill.

“The overwhelming efficacy achieved in our recent clinical study of Paxlovid and its potential to help save lives and keep people out of the hospital if authorized, underscores the critical role that oral antiviral therapies could play in the battle against COVID-19,” Pfizer chairman and CEO, Albert Bourla stated. “We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients and we look forward to working with the US FDA in its review of our application, along with other regulatory agencies around the world.”

Ana Ovey

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