- Treatment courses will be available for procurement by 132
Global Fund-eligible low-and-middle-income countries in all regions
of the world beginning in 2022, subject to local regulatory
approval or authorization
- The agreement is part of Pfizer’s comprehensive strategy to
work toward worldwide equitable access to COVID-19 oral
treatments
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.
LIMITATIONS OF AUTHORIZED USE
- PAXLOVID is not authorized for initiation of treatment in
patients requiring hospitalization due to severe or critical
COVID-19
- PAXLOVID is not authorized for use as pre-exposure or
post-exposure prophylaxis for prevention of COVID-19
- PAXLOVID is not authorized for use for longer than 5
consecutive days
PAXLOVID may only be prescribed for an individual patient by
physicians, advanced practice registered nurses, and physician
assistants that are licensed or authorized under state law to
prescribe drugs in the therapeutic class to which PAXLOVID belongs
(i.e., anti-infectives).
PAXLOVID is not approved for any use, including for use for the
treatment of COVID-19.
PAXLOVID is authorized only for the duration of the declaration
that circumstances exist justifying the authorization of the
emergency use of PAXLOVID under 564(b)(1) of the Food Drug and
Cosmetic Act unless the authorization is terminated or revoked
sooner.
IMPORTANT SAFETY INFORMATION
PAXLOVID is contraindicated in patients with a history of
clinically significant hypersensitivity reactions (eg, toxic
epidermal necrolysis [TEN] or Stevens-Johnson syndrome) to its
active ingredients (nirmatrelvir or ritonavir) or any other
components of the product.
Drugs listed in this section are a guide and not considered a
comprehensive list of all drugs that may be contraindicated with
PAXLOVID. The healthcare provider should consult other appropriate
resources such as the prescribing information for the interacting
drug for comprehensive information on dosing or monitoring with
concomitant use of a strong CYP3A inhibitor such as ritonavir.
PAXLOVID is contraindicated with drugs that are highly
dependent on CYP3A for clearance and for which elevated
concentrations are associated with serious and/or life-threatening
reactions:
- Alpha1-adrenoreceptor antagonist: alfuzosin
- Analgesics: pethidine, propoxyphene
- Antianginal: ranolazine
- Antiarrhythmic: amiodarone, dronedarone, flecainide,
propafenone, quinidine
- Anti-gout: colchicine
- Antipsychotics: lurasidone, pimozide, clozapine
- Benign prostatic hyperplasia agents: silodosin
- Cardiovascular agents: eplerenone, ivabradine
- Ergot derivatives: dihydroergotamine, ergotamine,
methylergonovine
- HMG-CoA reductase inhibitors: lovastatin, simvastatin
- Immunosuppressants: voclosporin
- Microsomal triglyceride transfer protein inhibitor:
lomitapide
- Migraine medications: eletriptan, ubrogepant
- Mineralocorticoid receptor antagonists: finerenone
- Opioid antagonists: naloxegol
- PDE5 inhibitor: sildenafil (Revatio®) when used for pulmonary
arterial hypertension
- Sedative/hypnotics: triazolam, oral midazolam
- Serotonin receptor 1A agonist/serotonin receptor 2A antagonist:
flibanserin
- Vasopressin receptor antagonists: tolvaptan
PAXLOVID is contraindicated with drugs that are potent CYP3A
inducers where significantly reduced nirmatrelvir or ritonavir
plasma concentrations may be associated with the potential for loss
of virologic response and possible resistance. PAXLOVID cannot be
started immediately after discontinuation of any of the following
medications due to the delayed offset of the recently discontinued
CYP3A inducer:
- Anticancer drugs: apalutamide
- Anticonvulsant: carbamazepine, primidone, phenytoin
- Cystic fibrosis transmembrane conductance regulator
potentiators: lumacaftor/ivacaftor
- Herbal Products: St. John’s Wort (hypericum perforatum)
There are limited clinical data available for PAXLOVID.
Serious and unexpected adverse events may occur that have
not been previously reported with PAXLOVID use.
Risk of Serious Adverse Reactions Due to Drug
Interactions: Initiation of PAXLOVID, a CYP3A inhibitor, in
patients receiving medications metabolized by CYP3A or initiation
of medications metabolized by CYP3A in patients already receiving
PAXLOVID, may increase plasma concentrations of medications
metabolized by CYP3A. Initiation of medications that inhibit or
induce CYP3A may increase or decrease concentrations of PAXLOVID,
respectively. These interactions may lead to:
- Clinically significant adverse reactions, potentially leading
to severe, life-threatening, or fatal events from greater exposures
of concomitant medications
- Clinically significant adverse reactions from greater exposures
of PAXLOVID
- Loss of therapeutic effect of PAXLOVID and possible development
of viral resistance
Consult Table 1 of the Fact Sheet for Healthcare Providers for
clinically significant drug interactions, including contraindicated
drugs. Drugs listed in Table 1 are a guide and not considered a
comprehensive list of all possible drugs that may interact with
PAXLOVID. Consider the potential for drug interactions prior to and
during PAXLOVID therapy; review concomitant medications during
PAXLOVID therapy and monitor for the adverse reactions associated
with the concomitant medications.
Hypersensitivity reactions have been reported with
PAXLOVID including urticaria, angioedema, dyspnea, mild skin
eruptions, and pruritus. Cases of anaphylaxis, TEN, and
Stevens-Johnson syndrome have also been reported with components of
PAXLOVID (refer to NORVIR labeling). If signs and symptoms of a
clinically significant hypersensitivity reaction or anaphylaxis
occur, immediately discontinue PAXLOVID and initiate appropriate
medications and/or supportive care.
Hepatotoxicity: Hepatic transaminase elevations, clinical
hepatitis, and jaundice have occurred in patients receiving
ritonavir. Therefore, caution should be exercised when
administering PAXLOVID to patients with pre-existing liver
diseases, liver enzyme abnormalities, or hepatitis.
Because nirmatrelvir is co-administered with ritonavir, there
may be a risk of HIV-1 developing resistance to HIV protease
inhibitors in individuals with uncontrolled or undiagnosed
HIV-1 infection.
Adverse events in the PAXLOVID group (≥1%) that occurred
at a greater frequency (≥5 subject difference) than in the placebo
group were dysgeusia (6% and <1%, respectively), diarrhea (3%
and 2%), hypertension (1% and <1%), and myalgia (1% and <1%).
The proportions of subjects who discontinued treatment due to an
adverse event were 2% in the PAXLOVID group and 4% in the placebo
group.
The following adverse reactions have been identified during
post-authorization use of PAXLOVID. Because these reactions are
reported voluntarily from a population of uncertain size, it is not
always possible to reliably estimate their frequency or establish a
causal relationship to drug exposure.
Immune System Disorders: Hypersensitivity reactions
Gastrointestinal Disorders: Abdominal pain, nausea General
Disorders and Administration Site Conditions: Malaise
Required Reporting for Serious Adverse Events and Medication
Errors: The prescribing healthcare provider and/or the
provider’s designee is/are responsible for mandatory reporting of
all serious adverse events and medication errors potentially
related to PAXLOVID within 7 calendar days from the healthcare
provider’s awareness of the event.
Submit adverse event and medication error reports to FDA
MedWatch using one of the following methods:
- Online: https://www.fda.gov/medwatch/report.htm
- Complete and submit a postage-paid FDA Form 3500 and
returning by mail/fax
- Call 1-800-FDA-1088 to request a reporting
form
In addition, please provide a copy of all FDA MedWatch forms to:
http://www.pfizersafetyreporting.com/ or by fax (1-866-635-8337) or
phone (1-800-438-1985).
PAXLOVID is an inhibitor of CYP3A and may increase plasma
concentrations of drugs that are primarily metabolized by CYP3A.
Co-administration of PAXLOVID with drugs highly dependent on CYP3A
for clearance and for which elevated plasma concentrations are
associated with serious and/or life-threatening events is
contraindicated. Co-administration with other CYP3A substrates may
require a dose adjustment or additional monitoring.
Nirmatrelvir and ritonavir are CYP3A substrates; therefore,
drugs that induce CYP3A may decrease nirmatrelvir and ritonavir
plasma concentrations and reduce PAXLOVID therapeutic effect.
Pregnancy: There are no available human data on the use
of nirmatrelvir during pregnancy to evaluate for a drug‑associated
risk of major birth defects, miscarriage, or adverse maternal or
fetal outcomes. Published observational studies on ritonavir use in
pregnant women have not identified an increase in the risk of major
birth defects. Published studies with ritonavir are insufficient to
identify a drug‑associated risk of miscarriage. There are maternal
and fetal risks associated with untreated COVID-19 in
pregnancy.
Lactation: There are no available data on the presence of
nirmatrelvir in human or animal milk, the effects on the breastfed
infant, or the effects on milk production. A transient decrease in
body weight was observed in the nursing offspring of rats
administered nirmatrelvir. Limited published data reports that
ritonavir is present in human milk. There is no information on the
effects of ritonavir on the breastfed infant or the effects of the
drug on milk production. The developmental and health benefits of
breastfeeding should be considered along with the mother's clinical
need for PAXLOVID and any potential adverse effects on the
breastfed infant from PAXLOVID or from the underlying maternal
condition. Breastfeeding individuals with COVID‑19 should follow
practices according to clinical guidelines to avoid exposing the
infant to COVID‑19.
Contraception: Use of ritonavir may reduce the efficacy
of combined hormonal contraceptives. Advise patients using combined
hormonal contraceptives to use an effective alternative
contraceptive method or an additional barrier method of
contraception.
Pediatrics: PAXLOVID is not authorized for use in
pediatric patients younger than 12 years of age or weighing less
than 40 kg. The safety and effectiveness of PAXLOVID have not been
established in pediatric patients. The authorized adult dosing
regimen is expected to result in comparable serum exposures of
nirmatrelvir and ritonavir in patients 12 years of age and older
and weighing at least 40 kg as observed in adults, and adults with
similar body weight were included in the trial EPIC-HR.
Systemic exposure of nirmatrelvir increases in renally impaired
patients with increase in the severity of renal impairment. No
dosage adjustment is needed in patients with mild renal impairment.
In patients with moderate renal impairment (eGFR ≥30 to <60
mL/min), reduce the dose of PAXLOVID to 150 mg nirmatrelvir and
100 mg ritonavir twice daily for 5 days. Prescriptions should
specify the numeric dose of each active ingredient within PAXLOVID.
Providers should counsel patients about renal dosing instructions.
PAXLOVID is not recommended in patients with severe renal
impairment (eGFR <30 mL/min based on CKD-EPI formula) until
more data are available; the appropriate dosage for patients with
severe renal impairment has not been determined.
No dosage adjustment of PAXLOVID is needed for patients with
either mild (Child-Pugh Class A) or moderate (Child-Pugh Class B)
hepatic impairment. No pharmacokinetic or safety data are available
regarding the use of nirmatrelvir or ritonavir in subjects with
severe hepatic impairment (Child-Pugh Class C); therefore,
PAXLOVID is not recommended for use in patients with severe
hepatic impairment.
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. In addition, to
learn more, please visit us on www.Pfizer.com and follow us on
Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us
on Facebook at Facebook.com/Pfizer.
Disclosure Notice
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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