The U.N.-backed Medicines Patent Pool (MPP) said Thursday that 35 global firms have agreed to manufacture the generic version of Pfizer’s oral COVID-19 drug, Paxlovid, for distribution in 95 low-and middle-income countries.
Paxlovid is a combination of two antiviral drugs–nirmatrelvir, which blocks the virus from replicating, and ritonavir–which slows down nirmatrelvir’s breakdown to help it remain in the body for a longer period of time.
MPP stated that the 35 companies were offered non-exclusive sublicenses, which will allow them to produce the raw ingredients for nirmatrelvir and the drug, based on their production capacity, regulatory compliance, and international standards.
“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,” MPP’s executive director Charles Gore said in a statement.
The 35 companies are based in 12 countries: Bangladesh, Brazil, China, Dominican Republic, Jordan, India, Israel, Mexico, Pakistan, Serbia, South Korea, and Vietnam, according to MPP’s statement.
Six companies will focus on producing the drug substance, and nine companies will produce the drug product, while the remainder will do both.
It stated that Pfizer will not receive royalties from the sale of the antiviral pill while the COVID-19 remains classified as a “public health emergency of international concern” by the World Health Organization.
“Following the pandemic period, sales to low-income countries will remain royalty-free, lower-middle-income countries and upper-middle-income countries will be subject to a 5 percent royalty for sales to the public sector and a 10 percent royalty for sales to the private sector,” MPP said.
Several countries have granted approval for the emergency use of Paxlovid, including Japan, Australia, China plus Hong Kong, Canada, and the United States. Hong Kong’s government said on March 15 that it has started distributing the Pfizer drug to the Hospital Authority for application.
The United States doubled its order for Paxlovid on Jan. 4, bringing the total purchase from 10 million to 20 million pills. Pfizer said that 10 million treatment courses will be delivered by the end of June, with the remaining 10 million to follow by the end of September.
The U.S. Food and Drug Administration (FDA) had also granted an emergency use of authorization for Paxlovid last December for patients with mild-to-moderate symptoms, with the pill available only by prescription.
The FDA said the pill “significantly reduced” the proportion of infected patients at risk of severe symptoms from any cause by 88 percent, compared to placebo among patients within five days of symptom onset and who did not get COVID-19 therapeutic monoclonal antibody treatment.