US pharmaceutical giant Pfizer is to make its prospective antiviral COVID-19 pill, Paxlovid, to 95 low-and middle-income nations covering about 53% of the world’s population.
The Guardian reports that under the licensing agreement deal struck with the global Medicines Patent Pool (MPP), Pfizer, which also produces one of the most widely used COVID vaccines with German lab BioNTech, will not receive royalties from the manufacturers, making the treatment cheaper.
The agreement is subject to the oral antiviral medication passing ongoing trials and regulatory approval.
The announcement comes after the MPP signed a similar voluntary licensing deal with Pfizer’s US rivals Merck & Co last month for its investigational oral antiviral medicine molnupiravir.
Subject to regulatory approval, the deal will help create broad access to molnupiravir in 105 low-and middle-income countries. Pills are easier to make than vaccines, do not require a cold chain for delivery and can be self-administered by the patient. As reported in MedicalBrief at the time, COVID vaccine-makers have resisted making similar agreements, despite pressure from governments and the World Health Organization.
Interim data from ongoing trials with Paxlovid demonstrated an 89% reduction in the risk of COVID-19-related hospitalisation or death compared with a placebo, in non-hospitalised high-risk adults with COVID-19, within three days of symptom onset, said Pfizer. Similar results were seen within five days of symptom onset, it added.
The Geneva-based MPP is a United Nations-backed international organisation that works to facilitate the development of medicines for low-and middle-income nations. If approved, Paxlovid could be on the market in “a matter of months”, MPP policy chief Esteban Burrone told Agence France-Presse.
Pfizer is also seeking an emergency use authorisation, or EUA, in the US for the COVID pill. Pfizer will forego royalties on sales 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.
Paxlovid, or PF-07321332, is an investigational antiviral therapy designed to block the activity of the Sars-CoV-2-3CL protease, an enzyme the coronavirus needs to replicate.
Taking it with a low dose of HIV medicine ritonavir helps slow the breakdown of PF-07321332. It therefore remains active in the body for a longer period at a high concentration, to help combat the virus.
“We believe oral antiviral treatments can play a vital role in reducing the severity of COVID-19 infections, decreasing the strain on our healthcare systems and saving lives,” said Pfizer chairman and chief executive Albert Bourla.
“This licence is so important because, if authorised or approved, the 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,” said Charles Gore, executive director of MPP. Potential sub-licensees have until 6 December to register an expression of interest.
Pricing for the Pfizer pill has not yet been set, with Doctors Without Borders (MSF) suggesting it might cost about $700 per Pfizer treatment course, in line with molnupiravir.
The medical charity said it was disheartened by the deal, saying restrictive voluntary licences were no substitute for guaranteed global access to COVID tools to bring the pandemic under control.
See more from MedicalBrief archives:
Merck foregoes royalties to allow global drugmakers to make its COVID-19 pill
Merck’s COVID antiviral pill may halve the risk of hospitalisation and death
IP and COVID-19 medicines: Why a WTO waiver may not be enough