With its highly anticipated COVID-19 oral treatment seemingly on a fast track to approval, Pfizer already is lining it up to be manufactured as a generic by countries in need.
Under an agreement with the Medicines Patent Pool (MPP), Pfizer will license Paxlovid to facilitate affordable global access. The deal will allow sub-licensees to supply 95 countries that account for 53% of the world's population, Pfizer said.
The arrangement mirrors the one made by Merck and Ridgeback with the MPP three weeks ago, allowing for needy countries to manufacture those drugmakers' COVID-19 pill molnupiravir. Molnupiravir also is expected to be endorsed by the FDA in the coming weeks.
Both deals are contingent upon regulatory authorizations or approvals. An FDA advisory group will meet on Nov. 30 to discuss Merck's application for molnupiravir.
Pfizer said it will not receive royalties on sales in low-income countries and will waive royalties in all countries covered by the agreement while COVID-19 remains classified as a public health emergency of international concern by the World Health Organization.
The MPP is a United Nations-backed organization which works to increase access to life-saving medicines to countries in need by pooling intellectual property and encouraging generic manufacturing. Since it was established in 2010, the MPP has struck other deals to provide affordable access to treatments for HIV, hepatitis C and tuberculosis.
"If authorized or approved, this oral drug is particularly well-suited for low- and middle-income countries and could play a critical role in saving lives, contributing to global efforts to fight the current pandemic,” Charles Gore, executive director of MPP, said in a statement.
Like Merck's, Pfizer’s licensing deal will allow manufacturing to happen anywhere, provided sales are to the designated countries.
Approval for Paxlovid appears likely after investigators halted a late-phase trial earlier this month when it showed the treatment cut the risk of hospitalization or death by 89% in COVID-19 patients considered at high risk to progress to a severe form of the virus. In the study of 1,219 people, there were no deaths among those who took Paxlovid, compared with 10 deaths in the placebo group.
Those results indicate that Pfizer’s treatment may be even more effective than Merck’s. Merck turned heads last month when it showed that molnupiravir slashed the risk of hospitalization and death by 50%. The drug, known commercially as Lagevrio, scored authorization for use in the U.K. two weeks ago.
On Tuesday, generic drugmaker Dr. Reddy’s Laboratories, already signed up to manufacture molnupiravir, revealed that it also would be open to producing Paxlovid.
Dr. Reddy’s is one of several manufacturers in India which entered into agreement with Merck before the MPP deal was unveiled. Others include Aurobindo, Cipla, Emcure, Hetero, Sun and Torrent. Beximco of Bangladesh also has agreed to produce molnupiravir.