NEW YORK - Pfizer Inc. (NYSE: PFE) announced today an agreement to supply up to six million treatment courses of its COVID-19 oral treatment, PAXLOVID (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) to Global Fund as part of its COVID-19 Response Mechanism (C19RM).
The C19RM has been the primary channel for providing grant support to low- and middle-income countries to purchase COVID-19 tests, treatments, personal protective equipment and critical elements of health systems strengthening. PAXLOVID treatment courses will be available for procurement through this mechanism, subject to local regulatory approval or authorization, by the 132 grant-eligible countries determined by Global Fund based on income classification and disease burden.
Pfizer expects supply to be available starting in 2022, pending regulatory authorization or approval and based on country demand. Through Global Fund's framework and mechanism, eligible countries will be offered treatment courses according to Pfizer's tiered pricing approach, where all low- and lower-middle-income countries will pay a not-for-profit price while upper-middle-income countries will pay the price defined in Pfizer's tiered pricing approach. Additional contractual details of the agreement were not disclosed.
'After so much disruption and loss due to COVID-19, we must continue to accelerate access to PAXLOVID as a treatment option for high-risk patients in all regions of the world along with test and treat programs that help get treatment quickly to those in need', said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. 'This agreement with Global Fund is a critical step that will boost equitable access for high-risk patients in low-and-middle-income countries.'
The Global Fund agreement, along with an agreement signed with UNICEF for the supply of up to four million treatment courses for low- and middle-income countries earlier this year, is part of Pfizer's comprehensive global strategy for equitable supply and access of PAXLOVID. This includes a voluntary licensing agreement with Medicines Patent Pool (MPP) to enable the development and distribution of generic versions of Pfizer's oral treatment to further expand long-term global supply and access. MPP has signed sublicense agreements with 38 manufacturers, who will supply the generic versions in 95 low- and lower-middle-income countries. Courses produced by these manufacturers are expected to be available as early as the fourth quarter of 2022.
Pfizer will also provide product donation and funding to the COVID Treatment Quick Start Consortium to support efforts to accelerate COVID-19 testing and improve access to treatments in under-resourced parts of the world.
Pfizer also looks to increase supply of PAXLOVID through An Accord for a Healthier World, a first-of-its-kind initiative to enable sustained, equitable access to high-quality medicines and vaccines for 1.2 billion people living in lower-income countries launched in May 2022. Through the Accord, Pfizer has committed to provide its patent-protected medicines and vaccines available in the U.S. or European Union, including PAXLOVID, on a not-for-profit basis to 45 lower-income countries and will collaborate with government and global health leaders to address barriers that limit access beyond supply, like diagnosis, education, infrastructure, storage and more.
About PAXLOVID (nirmatrelvir [PF-07321332] tablets and ritonavir tablets)
PAXLOVID is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV-2 3CL protease inhibitor) therapy. It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Nirmatrelvir [PF-07321332], which originated in Pfizer laboratories, is designed to block the activity of the Mpro, an enzyme that the coronavirus needs to replicate. Co-administration with a low dose of ritonavir helps slow the metabolism, or breakdown, of nirmatrelvir in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.
Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions.
Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. PAXLOVID, however, works intracellularly by binding to the highly conserved Mpro (3CL protease) of the SARS-CoV-2 virus to inhibit viral replication. Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1 and BA.2.
PAXLOVID is generally administered at a dose of 300 mg (two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of ritonavir, given twice-daily for five days. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.
U.S. FDA Emergency Use Authorization Statement
PAXLOVID has not been approved but has been authorized for emergency use by FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS CoV-2 viral testing, and who are at high-risk for progression to severe COVID-19, including hospitalization or death.
The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.
AUTHORIZED USE
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product PAXLOVID for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
About Pfizer: Breakthroughs That Change Patients Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com.
Disclosure Notice
The information contained in this release is as of September 22, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about Pfizer's efforts to combat COVID-19 and PAXLOVID (including qualitative assessments of available data, potential benefits, expectations for clinical trials, an agreement to supply up to six million treatment courses of PAXLOVID to Global Fund and the timing of supply thereunder, an agreement with MPP, efforts toward equitable supply and access, including an Accord for a Healthier World, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations, planned investment and anticipated manufacturing, distribution and supply), involving substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results including efficacy, safety and tolerability profile observed to date, in additional studies or in larger, more diverse populations following commercialization; uncertainties regarding the commercial impact of the results of the EPIC-SR and EPIC-PEP trials; the ability of PAXLOVID to maintain efficacy against emerging virus variants; the risk that serious and unexpected adverse events may occur that have not been previously reported with PAXLOVID use; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when any drug applications or submissions to request emergency use or conditional marketing authorization for any potential indications for PAXLOVID or any of Pfizer's other products or product candidates may be filed in particular jurisdictions and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when regulatory authorities in any jurisdictions may approve any applications or submissions for PAXLOVID or any of Pfizer's other products or product candidates that may be pending or filed, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of PAXLOVID or any of Pfizer's other products or product candidates, including development of products or therapies by other companies; risks related to the availability of raw materials for PAXLOVID; manufacturing capabilities or capacity; the risk that we may not be able to maintain or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand, which would negatively impact our ability to supply the estimated numbers of courses of PAXLOVID within the projected time periods; whether and when additional purchase agreements will be reached; the risk that demand for any products may be reduced or no longer exist which may lead to reduced revenues or excess inventory; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results and competitive developments.
A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned 'Risk Factors' and 'Forward-Looking Information and Factors That May Affect Future Results', as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
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