KUALA LUMPUR (March 22): Malaysia was not among countries selected to make low-cost generic versions of Pfizer’s Covid-19 oral antiviral treatment, with agreements signed instead with manufacturers from a dozen other countries.

In a statement last week, the UN-backed Medicines Patent Pool (MPP) said it had signed agreements with 35 companies to manufacture the generic version of Pfizer’s oral Covid-19 treatment nirmatrelvir, which in combination with a low dose of ritonavir can be supplied in 95 low- and middle-income countries.

The sublicence agreements are the result of the voluntary licensing agreement signed by MPP and Pfizer in November 2021 that will help enable the supply of the medicines to countries comprising approximately 53% of the world’s population.

MPP said the non-exclusive sublicence allows generic manufacturers to produce the raw ingredients for nirmatrelvir and/or the finished drug itself co-packaged with ritonavir.

The companies that were offered the sublicence demonstrated their ability to meet MPP’s requirements related to production capacity, regulatory compliance, as well as international standards for quality-assured medicines.

MPP said “six companies will focus on producing the drug substance, nine companies will produce the drug product and the remainder will do both”.

It said the companies span 12 countries: Bangladesh, Brazil, China, Dominican Republic, Jordan, India, Israel, Mexico, Pakistan, Serbia, Republic of Korea, and Vietnam.

MPP added that a licence has also been offered to a company in Ukraine, and that “the offer will remain available to them as they are not able to sign due to the current conflict”.

MPP executive director Charles Gore said nirmatrelvir “is a new product and requires substantial manufacturing capabilities to produce, and we have been very impressed with the quality of manufacturing demonstrated by these companies”.

“Furthermore, 15 companies are signing their first licence with MPP, and we warmly welcome our new generic manufacturing partners,” said Gore.

Meanwhile, Pfizer chairman and CEO, Albert Bourla said the company “has established a comprehensive strategy in partnership with worldwide governments, international global health leaders and global manufacturers to help ensure access to our oral Covid-19 treatment for patients in need around the world”.

“The MPP sublicensees and the additional capacity for Covid-19 treatment they will supply will play a critical role to help ensure that people everywhere, particularly those living in the poorest parts of the world, have equitable access to an oral treatment option against Covid-19,” he said.