Pfizer signs licensing deal allowing generic versions of COVID pill

GENEVA

US pharmaceutical Pfizer has signed an agreement allowing other drug makers to produce its COVID-19 antiviral treatment candidate for low- and middle-income countries, a UN-supported health organization announced on Tuesday

The voluntary agreement between the Medicines Patent Pool (MPP) was announced by Unitaid, an agency hosted by the World Health Organization (WHO), at a UN press conference.

"This is the first license allowing generic manufacturing of this drug. 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," said Unitaid spokesman Herve Verhoosel.

The voluntary license agreement for Pfizer's COVID-19 oral antiviral treatment candidate is administered with a low dose of ritonavir, an HIV drug, said Unitaid.

"The agreement will enable the Medicines Patent Pool to facilitate additional production and distribution of the investigational antiviral, pending regulatory authorization or approval, by granting sub-licenses to qualified generic medicine manufacturers, to facilitate greater access to the global population," said Verhoosel.

The drug will be "mostly available for people who are especially at risk," and would not be given to all COVID-19 patients, he said, adding that they hoped to avoid giving the impression that it would need to be administered after a person showed the first symptoms of the virus.

Unitaid is a global health agency seeking to prevent, diagnose, and treat diseases more quickly, cheaply and effectively, in low- and middle-income countries and is hosted by the WHO.

Verhoosel did not name a price for the medicine but said it would be adapted to low- and middle-income countries.

95 country base

"There are 95 countries as the geographical base for this project. All the low-income countries are part of the 95 plus many middle-income countries, mostly in Africa, Asia, and some in South America," said the Unitaid spokesman.

Under the terms of the license agreement between Pfizer and the MPP, qualified generic medicine manufacturers worldwide were granted sub-licenses to supply the new drug in combination with ritonavir to 95 countries.

The agreement will cover up to approximately 53% of the world's population, said Unitaid.

"This includes all low- and lower-middle-income countries and upper-middle-income countries in sub-Saharan Africa, as well as upper-middle-income countries that have transitioned to upper-middle-income status in the past five years," it added.

Pfizer will not receive royalties on sales in all countries covered by the agreement, including low-income nations, while COVID-19 remains classified as a Public Health Emergency of International Concern by the WHO.

Unitaid urges all pharmaceutical companies to commit to improving global access to all new tools and treatments in the countries most affected by the pandemic.

The work of Unitaid includes funding initiatives to address diseases such as HIV/AIDS, malaria, and tuberculosis, as well as HIV co-infections and co-morbidities such as cervical cancer and hepatitis C, and cross-cutting areas, such as fever management.

Unitaid said it is applying its expertise to address challenges in advancing new therapies and diagnostics for the COVID-19 pandemic.