COVID-19: Licensing agreement for new candidate drug ‘an important first step’

The oral antiviral therapy PF-07321332 is designed to block the activity of the SARS-CoV-2-3CL protease, an enzyme the coronavirus needs to replicate. 

It is administered together with low dose ritonavir, used in some treatments for HIV and hepatitis C. 

Landmark agreement 

The agreement will allow the UN-backed Medicines Patent Pool (MPP) to sub-license PF-07321332 for production and distribution by qualified generic medicine manufacturers worldwide, pending regulatory authorization and approval. 

“This is the first license allowing generic manufacturing of this drug”, said Hervé Verhoosel, spokesperson with Unitaid, the global health agency that created the MPP a decade ago. 

“It is an important first step to help ensure that the latest tools for fighting COVID-19 are available in low- and middle-income countries at the same time as they become available in the wealthiest nations.”  

Reduced risk of death 

PF-07321332 is administered with ritonavir so it can remain active in the body for longer periods of time at higher concentrations to help combat coronavirus.  

The combination was found to reduce risk of hospitalization or death by nearly 90 per cent, according to an interim analysis of phase two trials of non-hospitalized high-risk adults with COVID-19. 

Under the agreement, qualified generic medicine manufacturers that are granted sub-licenses will be able to supply PF-07321332, in combination with ritonavir, to 95 countries, covering around 53 per cent of the global population. 

They include all low- and middle-income countries in sub-Saharan Africa, as well as nations which have achieved upper-middle-income status in the past five years. 

Mr. Verhoosel said Pfizer will not receive royalties on sales in low-income countries. The company will also waive royalties on sales in all countries covered by the agreement while COVID-19 remains a Public Health Emergency of International Concern, as classified by the World Health Organization (WHO). 

Saving time and lives 

Unitaid, which is hosted by WHO, funds initiatives that address major diseases through innovative, low-cost and effective solutions. 

It established the MPP in 2010 to increase access to, and facilitate development of, life-saving medicines for low- and middle-income countries.  

Since then, agreements have been signed with patent holders for medicines and technologies against HIV, hepatitis C, tuberculosis, and now COVID-19. 

“During a pandemic, saving time means saving lives. This agreement will 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,” said Dr. Philippe Duneton, the Unitaid Executive Director. 

There have been more than 253 million confirmed cases of COVID-19 worldwide, and nearly 5.1 million deaths, according to latest WHO figures. 

Unitaid is part of the Access to COVID-19 Tools (ACT) Accelerator, which has distributed millions of vaccines globally through the COVAX solidarity mechanism. 

As co-lead of the Accelerator’s therapeutics pillar, the agency advocates for equitable and rapid access to new treatments. 

“To achieve this, multiple generic manufacturers must be ready to supply products to meet potential high demand, as soon as the new drug is approved by regulatory authorities,” said Mr. Verhoosel.