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.
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.
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.
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