- If approved, PF-07321332 in
combination with ritonavir would be the first oral antiviral
of its kind, a 3CL protease inhibitor specifically designed
to combat SARS-CoV-2.
· Courses are
expected to be delivered over 2022, subject to Medsafe
approval.
· Pfizer has begun a rolling
regulatory submission in New Zealand to
Medsafe.
Pfizer New Zealand announced today an
agreement with the New Zealand Government to supply 60,000
treatment courses of its investigational COVID-19 oral
antiviral candidate, PF-07321332; ritonavir, subject to
regulatory approval from Medsafe. If approved or authorised,
PF-07321332; ritonavir would be the first oral antiviral of
its kind, a 3CL protease inhibitor specifically designed to
combat SARS-CoV-2. A rolling regulatory submission has
commenced in New Zealand for provisional approval by
Medsafe.
Under the terms of the agreement, the New
Zealand Government will acquire an initial quantity of
60,000 treatment courses, subject to approval by Medsafe, to
be delivered to New Zealand over the course of 2022. Pricing
for PF-07321332; ritonavir, is based on the principles of
advance commitment, volume, equity and
affordability.
“We are honored to work with the New
Zealand Government toward achieving our shared goal of
addressing this public health crisis,” said Anne Harris,
Pfizer New Zealand Managing Director. “If approved , oral
protease inhibitor antiviral therapies may help to reduce
the severity or onset of illness in adults who contract, or
have been exposed to, COVID-19. An oral treatment option may
thus be an important potential tool to help address the
ongoing global impact of the COVID-19 pandemic,” Ms.
Harris said.
“We were very encouraged by the recent
results of our Phase 2/3 interim analysis, which showed
overwhelming efficacy of PF-07321332; ritonavir in reducing
the risk of hospitalisation compared to placebo among
high-risk patients adults treated within three days of
symptom onset by almost 90% and with no deaths, with similar
results seen with those treated within five days, and are
pleased that the New Zealand Government recognises this
potential.
“It is promising 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 our discussions with the New Zealand
Government to help ensure broad access for New
Zealanders”, Ms Harris said.
PF-07321332; ritonavir
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
authorised or approved, PF-07321332; ritonavir 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 PF-07321332; ritonavir for all
people, aiming to deliver safe and effective antiviral
therapeutics as soon as possible and at an affordable price.
If authorised 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 will continue to invest up to
approximately US$1 billion to support the manufacturing and
distribution of this investigational treatment candidate,
including exploring potential contract manufacturing
options. It has entered into 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 authorisation 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-hospitalised 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 29
September, 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 randomised
(1:1) to receive PF-07321332; ritonavir or placebo orally
every 12 hours for five days.
The scheduled interim
analysis showed an 89% reduction in risk of COVID-19-related
hospitalisation or death from any cause compared to placebo
in adults treated within three days of symptom onset
(primary endpoint); 0.8% of patients who received
PF-07321332; ritonavir were hospitalised through Day 28
following randomisation (3/389 hospitalised with no deaths),
compared to 7.0% of patients who received placebo and were
hospitalised or died (27/385 hospitalised with 7 subsequent
deaths). The statistical significance of these results was
high (p
The
review of safety data included a larger cohort of 1,881
adult patients in EPIC-HR, whose data were available at the
time of the analysis. Treatment-emergent adverse events were
comparable between PF-07321332; ritonavir (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 adults dosed with PF-07321332;
ritonavir 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 randomised,
double-blind study of non-hospitalised 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 adults 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 adults 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 PF-07321332;
ritonavir, visit clinicaltrials.gov.
About
Pfizer New Zealand: Breakthroughs That Change Patients’
LivesTM
At Pfizer, we apply science and our global
resources to improve health and wellbeing at every stage of
life. We strive to set the standard for quality, safety and
value in the discovery, development and manufacturing of
medicines. Our diversified global health care portfolio
includes biologic and small molecule medicines and
vaccines.
Consistent with our responsibility as one of
the world’s leading biopharmaceutical companies, we also
collaborate with healthcare providers, governments and local
communities to support and expand access to reliable,
affordable health care around the world. For more than 150
years, we have worked to make a difference for all who rely
on us. To learn more, please visit us on www.pfizer.co.nz and
follow us on Twitter at @Pfizer
and @PfizerNews,
LinkedIn,
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and
like us on Facebook at Facebook.com/Pfizer.
Disclosure
Notice
The information contained in this release
is as of 6 December 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 COVID-19 oral
antiviral clinical candidate, PF-07321332 in combination
with ritonavir (including qualitative assessments of
available data, potential benefits, expectations for
clinical trials, an agreement with the New Zealand
Government and the timing of delivery of courses thereunder,
the anticipated timing of data readouts, regulatory
submissions, regulatory approvals or authorisations 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 for any potential
indications for PF-07321332 or any other protease inhibitors
may be filed in any jurisdictions; whether and when
regulatory authorities in any jurisdictions may approve any
such applications for PF-07321332 or any other protease
inhibitors, 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 PF-07321332 or any
other protease inhibitors, including development of products
or therapies by other companies; risks related to the
availability of raw materials to manufacture PF-07321332 or
any other protease inhibitors; 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 for PF-07321332 or
any other protease inhibitors, which would negatively impact
our ability to supply the estimated numbers of courses of
PF-07321332 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 31 December, 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.
