COVID-19: New Candidate Licensing Agreement ‘An Important First Step’ |

Oral Antiviral Therapy PF-07321332 is designed to block the activity of SARS-CoV-2-3CL protease, an enzyme, coronavirus must be reproduced.

It is co-administered with low-dose ritonavir, which is used in some HIV and hepatitis C treatments.

If allowed or approved, it could be another tool against the pandemic.

Signed agreement

The agreement will allow the United Nations-supported Medicines Patent Pool (MPP) to sublicense PF-07321332 for production and distribution by qualified generic manufacturers worldwide, pending regulatory approval and approval.

“This is the first license to authorize generic production of this drug,” said Hervé Verhusel, a spokesman for Unite, the global health agency that created MPP ten years ago.

“This is an important first step in making sure the latest combat tools are COVID-19 available in low- and middle-income countries at the same time as they become available in the richest countries. ”

Reduced risk of death

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

The combination was found to reduce the risk of hospitalization or death by up to 90 percent, according to an interim analysis of phase 2 trials involving non-legalized high-risk adults with COVID-19.

Under the agreement, sublicensed qualified generic drug manufacturers will be able to supply PF-07321332 in combination with ritonavir to 95 countries, representing about 53 percent of the world’s population.

This includes all low- and middle-income countries in sub-Saharan Africa, as well as countries that have achieved upper-middle income status in the past five years.

Verhusel said Pfizer will not receive royalties on sales in low-income countries. The company will also waive sales license royalties 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, hosted by WHO, funds initiatives to tackle major diseases with innovative, affordable and effective solutions.

In 2010, he established the MPP to expand access to life-saving drugs and promote their development for low- and middle-income countries.

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

“In a pandemic, saving time means saving lives. This agreement will help us reach more people faster once a drug is approved and, combined with increased access to testing, will benefit millions. “ said Dr. Philip Daneton, CEO of Unitaid.

There are more than 253 million confirmed COVID-19 cases and nearly 5.1 million deaths worldwide, according to the latest WHO data.

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

As co-director of Therapy Accelerator, the agency advocates fair and fast access to new therapies.

“To achieve this, several generic manufacturers must be prepared to supply products to meet potentially high demand once a new drug is approved by regulators,” said Mr Verhusel.

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