- Pfizer will allow other drugmakers to cheaply produce its experimental COVID-19 drug, announcing Tuesday a licensing agreement with a United Nations-backed group aimed at expanding access to the antiviral pill outside of wealthy countries.
- The pact with The Medicines Patent Pool permits the public health-focused organization to sublicense rights to generic manufacturers to make and supply Pfizer's drug in 95 countries covering just over half of the world's population. Per the agreement, Pfizer will waive royalties on sales while COVID-19 is classified as a public health emergency by the World Health Organization, and won't claim any royalties on sales in low-income countries thereafter.
- The agreement is similar to one The Medicines Patent Pool struck with Merck & Co. for its COVID-19 pill molnupiravir, developed together with Ridgeback Biotherapeutics. While the two drugs work differently, both have proved in testing to dramatically reduce the risk of hospitalization and death from COVID-19 when given soon after coronavirus infection.
Pfizer is sharing rights to make its COVID-19 pill even as it closely guards the recipe for its coronavirus vaccine, which has mostly been supplied to high- or upper middle-income countries and is set to make the company $36 billion this year.
The pill, called Paxlovid, is not yet approved for use in any country. But recent study results showed treatment with the drug cut the risk of hospitalization or death from COVID-19 by nearly 90% versus placebo for patients who received it within three days of symptoms. Pfizer ended the study early as a result and is working to soon submit an application for emergency authorization to the Food and Drug Administration.
As an oral and comparatively easy-to-manufacture drug, Paxlovid could have a large impact in countries with less developed healthcare infrastructure. Pfizer's deal with The Medicines Patent Pool could expand access considerably, although it may still take some time for the group to sign sub-licenses and for generic manufacturers to ramp up production following regulatory approvals.
"The licensed territory is large and underserved by vaccine manufacturers, making inexpensive to manufacture therapeutics particularly important," said James Love, director of the advocacy group Knowledge Ecology International.
"Pfizer deserves credit for engaging with the MPP and agreeing to transparency, open and procompetitive licensing in the middle of a pandemic for this product," he added.
Ninety-five countries in all are covered by the agreement, 10 fewer than the 105 included in Merck's agreement with The Medicines Patent Pool for its drug molnupiravir. (Pfizer excluded 17 countries covered by Merck's deal, but added seven that weren't.)
Pfizer's licensing agreements allow generic manufacturers granted rights to produce Paxlovid anywhere, as long as they supply within the 95 covered countries.
Paxlovid is administered alongside an old HIV drug called ritonavir that slows the body's metabolism of Pfizer's drug, giving it more time to block coronavirus replication. The Medicines Patent Pool says it also has licenses in place for ritonavir, which is sold by AbbVie and several generic drugmakers in the U.S.
"[Paxlovid] is to be taken together with ritonavir, an HIV medicine we know well, as we have had a license on it for many years, and we will be working with generic companies to ensure there is enough supply for both COVID-19 and HIV," said Charles Gore, executive director of The Medicines Patent Pool, in a Nov. 16 statement.
It's unclear exactly how many treatment courses of Paxlovid Pfizer could supply this year, should the pill win authorization in the U.S. and elsewhere. Company CEO Albert Bourla has indicated his company could produce 50 million courses next year.
Depending on how many generic manufacturers sign up to make Paxlovid through The Medicines Patent Pool, that number could rise significantly. One, Dr. Reddy's of India, has already indicated interest.
Pfizer also hasn't said how much it will charge for a course of Paxlovid, although the treatment likely would be available for less when produced by generic drugmakers for use in lower-income countries.
Merck, which recently won authorization in the U.K. for molnupiravir, has signed supply deals with the U.S. that suggest a price of about $700 per treatment course, although that figure may change in other contracts.