- If approved or authorized, PAXLOVID™ (PF-07321332; ritonavir)
would be the first oral antiviral of its kind, a 3CL protease
inhibitor specifically designed to combat SARS-CoV-2
- Pfizer is seeking Emergency Use Authorization of PAXLOVID with
the U.S. FDA and is working to submit applications to regulatory
agencies around the world.
- The company has entered into a voluntary license agreement with
the Medicines Patent Pool to help expand access in 95 low- and
middle-income countries that account for approximately 53% of the
world’s population, pending authorization or approval
Pfizer Inc. (NYSE: PFE) today announced an agreement with the
U.S. government to supply 10 million treatment courses of its
investigational COVID-19 oral antiviral candidate, PAXLOVID™
(PF-07321332; ritonavir), subject to regulatory authorization from
the U.S. Food and Drug Administration (FDA). If approved or
authorized, PAXLOVID, which originated in Pfizer’s laboratories,
would be the first oral antiviral of its kind, a 3CL protease
inhibitor specifically designed to combat SARS-CoV-2. Pfizer is
seeking Emergency Use Authorization (EUA) of PAXLOVID with the U.S.
FDA; rolling submissions have also commenced in several countries,
and the company will continue working to submit applications to
regulatory agencies around the world.
Under the terms of the agreement, the U.S. government will
acquire 10 million treatment courses to be delivered by Pfizer
beginning later this year and concluding in 2022. Pfizer will
receive $5.29 billion from the U.S. government, pending and
contingent upon regulatory authorization. Pricing for PAXLOVID is
based on the principles of advance commitment, volume, equity, and
affordability. The price being paid by the U.S. government is
reflective of the high committed volume of treatment courses being
purchased through 2022. The company has also entered into advance
purchase agreements with several other countries and has initiated
bilateral outreach to approximately 100 countries around the
world.
“We were thrilled with the recent results of our Phase 2/3
interim analysis, which showed overwhelming efficacy of PAXLOVID in
reducing the risk of hospitalization among high-risk patients
treated within three days of symptom onset by almost 90% and with
no deaths, and are pleased the U.S. government recognizes this
potential,” said Albert Bourla, Chairman and Chief Executive
Officer, Pfizer. “It is encouraging to see a growing understanding
of the valuable role that oral investigational therapies may play
in combatting COVID-19, and we look forward to continuing
discussions with governments around the world to help ensure broad
access for people everywhere.”
PF-07321332 is designed to block the activity of the
SARS-CoV-2-3CL protease, an enzyme that the coronavirus needs to
replicate, at a stage known as proteolysis – which occurs before
viral RNA replication. Co-administration with a low dose of
ritonavir helps slow the metabolism, or breakdown, of PF-07321332
in order for it to remain active in the body for longer periods of
time at higher concentrations to help combat the virus. In
preclinical studies, PF-07321332 did not demonstrate evidence of
mutagenic DNA interactions. If authorized or approved, PAXLOVID
will be administered at a dose of 300mg (two 150mg tablets) of
PF-07321332 with one 100mg tablet of ritonavir, given twice-daily
for five days.
Our Commitment to Equitable Access
Pfizer is committed to working toward equitable access to
PAXLOVID for all people, aiming to deliver safe and effective
antiviral therapeutics as soon as possible and at an affordable
price. If authorized or approved, during the pandemic, Pfizer will
offer our investigational oral antiviral therapy through a tiered
pricing approach based on the income level of each country to
promote equity of access across the globe. High and upper-middle
income countries will pay more than lower income countries.
Pfizer has also begun and will continue to invest up to
approximately $1 billion of its own funds to support the
manufacturing and distribution of this investigational treatment
candidate, including exploring potential contract manufacturing
options. It has entered into advance purchase agreements with
several countries and has initiated bilateral outreach to
approximately 100 countries around the world. Additionally, Pfizer
has signed a voluntary licensing agreement with the Medicines
Patent Pool (MPP) to help expand access, pending regulatory
authorization or approval, in 95 low- and middle-income countries
that account for approximately 53% of the world’s population.
About the Phase 2/3 EPIC-HR Study Interim Analysis
In July 2021, Pfizer initiated the Phase 2/3 EPIC-HR
(Evaluation of Protease Inhibition for COVID-19 in High-Risk
Patients) randomized, double-blind study of non-hospitalized adult
patients with COVID-19, who are at high risk of progressing to
severe illness. The primary analysis of the interim data set
evaluated data from 1,219 adults who were enrolled by September 29,
2021. At the time of the decision to stop recruiting patients,
enrollment was at approximately 70% of the 3,000 planned patients
from clinical trial sites across North and South America, Europe,
Africa, and Asia, with 45% of patients located in the United
States. Enrolled individuals had a laboratory-confirmed diagnosis
of SARS-CoV-2 infection within a five-day and were required to have
at least one characteristic or underlying medical condition
associated with an increased risk of developing severe illness from
COVID-19. Each patient was randomized (1:1) to receive PAXLOVID or
placebo orally every 12 hours for five days.
The scheduled interim analysis showed an 89% reduction in risk
of COVID-19-related hospitalization or death from any cause
compared to placebo in patients treated within three days of symptom onset (primary
endpoint); 0.8% of patients who received PAXLOVID were hospitalized
through Day 28 following randomization (3/389 hospitalized with no
deaths), compared to 7.0% of patients who received placebo and were
hospitalized or died (27/385 hospitalized with 7 subsequent
deaths). The statistical significance of these results was high
(p<0.0001). Similar reductions in COVID-19-related
hospitalization or death were observed in patients treated
within five days of symptom onset;
1.0% of patients who received PAXLOVID were hospitalized through
Day 28 following randomization (6/607 hospitalized, with no
deaths), compared to 6.7% of patients who received a placebo
(41/612 hospitalized with 10 subsequent deaths), with high
statistical significance (p<0.0001). In the overall study
population through Day 28, no deaths were reported in patients who
received PAXLOVID as compared to 10 (1.6%) deaths in patients who
received placebo.
The review of safety data included a larger cohort of 1,881
patients in EPIC-HR, whose data were available at the time of the
analysis. Treatment-emergent adverse events were comparable between
PAXLOVID (19%) and placebo (21%), most of which were mild in
intensity. Among the patients evaluable for treatment-emergent
adverse events, fewer serious adverse events (1.7% vs. 6.6%) and
discontinuation of study drug due to adverse events (2.1% vs. 4.1%)
were observed in patients dosed with PAXLOVID compared to placebo,
respectively.
About the EPIC Development Program
The EPIC (Evaluation of
Protease Inhibition for COVID-19) Phase 2/3 development program for
PF-07321332; ritonavir consists of three clinical trials spanning a
broad spectrum of patients, including adults who have been exposed
to the virus through household contacts, as well as adults at both
standard risk and high risk of progressing to severe illness.
In July 2021, Pfizer initiated the first of these trials, known
as EPIC-HR, a randomized, double-blind study of non-hospitalized
adult patients with COVID-19, who are at high risk of progressing
to severe illness. At the recommendation of an independent Data
Monitoring Committee and in consultation with the U.S. FDA, Pfizer
has ceased further enrollment into the study due to the
overwhelming efficacy demonstrated in these results.
In August 2021, Pfizer began the Phase 2/3 EPIC-SR
(Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients), to evaluate efficacy and
safety in patients with a confirmed diagnosis of SARS-CoV-2
infection who are at standard risk (i.e., low risk of
hospitalization or death). EPIC-SR includes a cohort of vaccinated
patients who have an acute breakthrough symptomatic COVID-19
infection and who have risk factors for severe illness. In
September, Pfizer initiated the Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) to evaluate efficacy and safety
in adults exposed to SARS-CoV-2 by a household member. These trials
are ongoing.
For more information on the EPIC Phase 2/3 clinical trials for
PAXLOVID, visit clinicaltrials.gov.
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
The information contained in this release is as of November 18,
2021. 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 Pfizer’s investigational oral
antiviral candidate PAXLOVID (including qualitative assessments of
available data, potential benefits, expectations for clinical
trials, a supply agreement with the U.S. government and the timing
of delivery of doses thereunder, other advanced purchase agreements
and an agreement with MPP, efforts toward equitable access, a
submission to the FDA requesting EUA and submissions in other
jurisdictions, 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; 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 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
such applications or submissions for PAXLOVID (including the
submission for EUA pending with the FDA and rolling submissions in
other jurisdictions), 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, including development of products
or therapies by other companies; risks related to the availability
of raw materials for PAXLOVID; the risk that we may not be able to
create 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; 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, 2020 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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