Pfizer and Medicines Patent Pool Reach ‘Ground-breaking’ Voluntary Licensing Deal for New COVID-19 Treatment Pill COVID-19 16/11/2021 • Kerry Cullinan Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Pfizer global headquarters in New York. Pfizer has signed a voluntary license with the Medicines Patent Pool (MPP) to share the patents and knowledge to manufacture its new COVID-19 treatment drug, Paxlovid. According to the agreement, the MPP will be able to granting sub-licenses to qualified generic medicine manufacturers to supply the medicine in 95 countries, once regulatory authorization or approval has been granted. All low- and lower-middle-income countries and some upper-middle-income countries in sub-Saharan Africa, as well as countries that have transitioned from lower-middle to upper-middle-income status in the past five years, are covered by the license, according to a statement from MPP. “Pfizer will not receive royalties on sales in low-income countries and will further waive 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,” according to the statement. “Pfizer remains committed to bringing forth scientific breakthroughs to help end this pandemic for all people. 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 CEO Albert Bourla. “This license is so important because, 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,” said Charles Gore, Executive Director of MPP. ‘Potentially game-changing’ In a recent trial, Paxlovid showed an 89% reduction in the risk of COVID-related hospitalisation and death, Pfizer announced recently. In the light of this “overwhelming efficacy”, Pfizer abandoned the final phase of the trial is seeking emergency use approval for Paxlovid from the US Food and Drug Administration (FDA) before 25 November. While the voluntary license with the MCC restricts the sale of Paxlovid to 95 countries, it allows manufacturing to take place anywhere. “Pfizer’s license with the MPP will allow the rapid scale-up of manufacturing of what appears to be an effective and safe treatment for COVID-19,” said James Love, Director of Knowledge Ecology International (KEI), describing the license as “potentially game-changing”. “The licensed territory is large and underserved by vaccine manufacturers, making it inexpensive to manufacture therapeutics particularly important. The ‘manufacture anywhere’ feature of the license provides the right model for scaling manufacturing in a pandemic, where speed and decentralization are desired,” added Love. “Pfizer deserves credit for engaging with the MPP and agreeing to transparency, open and pro-competitive licensing in the middle of a pandemic for this product.” According to KEI’s analysis, the Pfizer license is similar to the voluntary license between the MPP and Merck for its COVID-19 treatment, molnupiravir, announced late last month. However, the Pfizer license excludes 17 countries that were included in the Merck license, and adds seven others, and generally targets countries with lower per capita incomes. Countries excluded include Brazil, Cuba and Jamaica. The Pfizer-MCC agreement also makes it possible for the sale of Paxloid outside the 95 countries in places where there is no patent or compulsory license, “as long as the manufacturer has licensed the patents, but not the know-how”, according to KEI. MSF condemns ‘restrictive’ deal MSF’s Yuan Qiong Hu However, Medecins Sans Frontieres (MSF) was less complimentary, with its senior legal policy officer Yuan Qiong Hu saying that the 95 countries included only covered 53% of the world’s population. “We are disheartened to see yet another restrictive voluntary license during this pandemic while cases continue to rise in many countries around the world,” said Hu. “Many upper-middle-income countries, such as Argentina, Brazil, China, Malaysia and Thailand, where established generic production capacity exists, are excluded from the license territory.” Hu also condemned Pfizer’s stated intention to pursue a tiered-pricing strategy, punting a price of around $700 for a five-day course of the medicine in high-income countries, with prices for low and middle-income countries still under discussion. “We know from experience [tired-pricing] is unnecessarily complex, keeps the decision-making power entirely in the hands of the pharmaceutical corporations, and results in higher prices in many countries,” said Hu. No deaths, few hospitalisations Paxlovid treatment requires 300 mg of the medicine twice a day, along with 100mg of an older anti-viral, ritonavir, typically for five days. Ritonavir is an antiretroviral medicine used to treat HIV that is no longer covered by patents. “Pfizer should refrain from seeking any new monopolies on ritonavir, either solely or in combination with the other compound, as the drug remains an important part of some antiretroviral regimens for people living with HIV,” warned MSF’s Hu. Interim analysis of the Paxlovid-Ritonavir trial on non-hospitalized adult patients with COVID-19 at high risk of progressing to severe illness, showed that only three (0.8%) of the 389 people who got the medicine within three days of symptoms went to hospital and none died. In comparison, 27 (7%) out of the 385 patients on the placebo were hospitalised and seven later died. Image Credits: AMR Industry Alliance, Coolcaesar/ Wikipedia. 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