Thirty-five manufacturers around the world have signed agreements to produce generic versions of Pfizer’s Covid pills and sell them inexpensively in 95 lower-income countries that together are home to more than half the world’s people.
The Medicines Patent Pool, a United Nations-backed nonprofit organization that negotiated a licensing agreement with Pfizer last fall, announced the roster of participating companies on Thursday.
The manufacturers stand to significantly expand the global supply of the antiviral treatment, which Pfizer sells under the brand name Paxlovid. The treatment has been found to be highly effective in staving off severe disease when given to high-risk patients early in the course of a coronavirus infection. Because it is made in pill form and can be taken at home, Paxlovid is much easier to distribute than treatments like monoclonal antibodies that are typically given intravenously.
The 35 companies will take out sublicenses to make the drug, package the pills or perform both of those steps in the manufacturing process. They operate in 12 countries in Asia, Europe and the Americas.
The Medicines Patent Pool said that a 36th company, in Ukraine, has been unable to sign a sublicense because of the war there, but that the offer to do so will remain open.
It will take months for many of the manufacturers to get production started, and it is not clear how much of the treatment they will be able to produce this year.
A course of Paxlovid involves taking two drugs in concert, in a total of 30 pills over five days. Twenty of the pills contain the principal drug, nirmatrelvir, which was developed by Pfizer and will be made under license by the 35 manufacturers. The other 10 pills in the treatment contain a low dose of ritonavir, a generic H.I.V. drug that slows the breakdown of nirmatrelvir so that it remains active in the body longer.
Pfizer has said it can produce 120 million courses of the pills in 2022, and wealthy countries have locked up much of the early supply. An official of the African Union said last week that the bloc had reached a deal to buy supplies of Paxlovid for member countries.
The Medicines Patent Pool said that the 35 manufacturers will not pay royalties to Pfizer as long as the World Health Organization still classifies the Covid pandemic as a public health emergency. After the emergency period ends, the manufacturers will continue to be able to sell their pills royalty-free to lower-income countries, but will have to pay Pfizer a royalty of 5 to 10 percent for sales to middle-income countries.
The pool organization reached a similar deal with Merck for its Covid pill, molnupiravir, to be made by other manufacturers and sold inexpensively in 105 lower-income countries. Twenty-seven generic drug makers in 11 countries have signed on to produce molnupiravir for that effort.
The successful efforts to arrange for wider manufacturing of Covid pills contrast with what has happened with coronavirus vaccines during the pandemic. Pfizer and Moderna, the makers of the two vaccines that use messenger RNA technology, have not heeded calls to share their vaccine formulas and transfer their technology to other manufacturers so that production could be expanded.
TNYT