- Expansion will create more than 250 additional high-skilled
manufacturing jobs at Pfizer’s Kalamazoo site
Pfizer Inc. (NYSE: PFE) announced today that it will further
strengthen its commitment to United States manufacturing with a
$120 million investment at its Kalamazoo, Michigan, facility,
enabling U.S.-based production in support of its COVID-19 oral
treatment, PAXLOVIDTM (nirmatrelvir [PF-07321332] tablets and
ritonavir tablets). The investment will expand the production of
active pharmaceutical ingredient (API) and registered starting
materials (RSMs) used in the manufacture of nirmatrelvir, a novel
main protease (Mpro) inhibitor originating in Pfizer’s
laboratories, which will create more than 250 additional
high-skilled jobs at Pfizer’s Kalamazoo site. This investment is
another major step in Pfizer’s effort to bring more key
biopharmaceutical manufacturing to the U.S., increasing Pfizer’s
capability to produce and supply treatments and medicines for
patients in the U.S. and around the world.
“Pfizer Global Supply has made the impossible possible, making
billions of vaccine doses and now millions of treatment courses to
help battle the deadly COVID-19 pandemic,” said Albert Bourla,
Chairman and Chief Executive Officer, Pfizer. “By increasing
production at our Michigan facility, we are both helping patients
around the world and expanding important manufacturing innovation
to the U.S. This investment builds upon our $5 billion of
investments across our manufacturing and distribution portfolio
since 2017 to support the ongoing growth of U.S. manufacturing
leadership.”
RSMs are the raw materials that are chemically converted into
API, which is the active ingredient in a medicine. Producing
PAXLOVID requires a significant amount of manufacturing capacity
across all aspects of the production process. To date, Pfizer has
shipped 12 million courses of PAXLOVID across 37 countries,
including 5 million courses shipped to the U.S., and has
manufactured almost 17 million treatment courses total. The
significant investment being made in stateside API and RSM
production for nirmatrelvir will allow Pfizer to increase supply
capacity for PAXLOVID as needed to help meet global demand. With
this new investment, Kalamazoo will be among the world's largest
producers of API, with the capacity to produce 1,200 metric tons
annually.
“Pfizer’s $120 million expansion in Kalamazoo creating 250
good-paying jobs to support the manufacture of PAXLOVID will build
on Michigan’s economic momentum,” said Governor Gretchen Whitmer.
“Pfizer’s Kalamazoo facility also made some of the first doses of
the vaccine, and now this proud Michigan company will play an even
more critical role in the fight against COVID-19. By creating
opportunities for Michiganders, Pfizer is helping us grow our
economy, create good-paying jobs, and help families.”
Pfizer also plans to expand its Modular Aseptic Processing (MAP)
sterile injectable pharmaceutical production facility in Kalamazoo
with a phase two investment. The expansion adds to the initial
investment of $450 million in phase one to build a
400,000-square-foot production facility and further establishes
Kalamazoo as one of the most technically advanced sterile
injectable pharmaceutical production facilities in the world.
“Pfizer’s Kalamazoo facility has been at the forefront of
pharmaceutical manufacturing for more than 135 years through the
legacy company Upjohn,” said Mike McDermott, Chief Global Supply
Officer, Pfizer. “The Kalamazoo facility uses some of our most
innovative manufacturing technology and has been essential in
Pfizer’s fight against COVID-19, producing nearly one billion doses
of COVID-19 vaccine at the site to date. Through this expansion, we
will continue to invest in the next generation of manufacturing and
supply chain resilience.”
Results from Pfizer’s EPIC-HR (Evaluation of Protease Inhibition
for COVID-19 in High-Risk Patients) study showed an 88% reduction
in COVID-19-related hospitalization or death from any cause in
adults treated with PAXLOVID compared to placebo within five days
of symptom onset. PAXLOVID is currently approved or authorized for
conditional or emergency use in more than 60 countries across the
globe to treat high-risk COVID-19 patients.
To learn more about Pfizer’s manufacturing and global supply,
visit www.pfizer.com/pgs.
About the EPIC-HR Final Results In the final analysis of
the primary endpoint from all patients enrolled in EPIC-HR, an 89%
reduction in COVID-19-related hospitalization or death from any
cause compared to placebo in patients treated within three days of
symptom onset was observed, consistent with the interim analysis.
In addition, a consistent safety profile was observed.
0.7% of patients who received PAXLOVID were hospitalized through
Day 28 following randomization (5/697 hospitalized with no deaths)
compared to 6.5% of patients who received placebo and were
hospitalized or died (44/682 hospitalized with 9 subsequent
deaths). The statistical significance of these results was high
(p<0.0001). In a secondary endpoint, PAXLOVID reduced the risk
of hospitalization or death from any cause by 88% compared to
placebo in patients treated within five days of symptom onset; 0.8%
of patients who received PAXLOVID were hospitalized or died through
Day 28 following randomization (8/1,039 hospitalized with no
deaths) compared to 6.3% of patients who received placebo (66/1,046
hospitalized with 12 subsequent deaths), with high statistical
significance (p<0.0001). In the overall study population through
Day 34, no deaths were reported in patients who received PAXLOVID
as compared to 13 deaths in patients who received placebo. In the
EPIC-HR trial, in a secondary endpoint, SARS-CoV-2 viral load at
baseline and Day 5 have been evaluated for 1,574 patients. After
accounting for baseline viral load, geographic region, and serology
status, PAXLOVID reduced viral load by approximately 10-fold
relative to placebo when treatment was initiated within three days
of symptom onset, indicating robust activity against SARS-CoV-2 and
representing the strongest viral load reduction reported to date
for an oral COVID-19 agent.
Treatment-emergent adverse events were comparable between
PAXLOVID (23%) and placebo (24%), most of which were mild in
intensity. Fewer serious adverse events (1.6% vs. 6.6%) and
discontinuations of study drug due to adverse events (2.1% vs.
4.2%) were observed in patients dosed with PAXLOVID compared to
placebo, respectively.
All other secondary endpoints for this study are available on
clinicaltrials.gov (NCT04960202) and EudraCT (2021-002895-38).
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.
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
- Ergot derivatives: dihydroergotamine, ergotamine,
methylergonovine
- HMG-CoA reductase inhibitors: lovastatin, simvastatin
- PDE5 inhibitor: sildenafil (Revatio®) when used for pulmonary
arterial hypertension
- Sedative/hypnotics: triazolam, oral midazolam
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, phenobarbital, phenytoin
- Antimycobacterials: rifampin
- 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. 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 ofHIV-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
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
The information contained in this release is as of June 6, 2022.
Pfizer assumes no obligation to update forward-looking statements
contained in this statement 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, the anticipated timing of data readouts,
regulatory submissions, regulatory approvals or authorizations, use
in high risk COVID-19 patients, planned investment and anticipated
manufacturing, distribution and supply, including a planned
investment at Pfizer’s Kalamazoo, Michigan facility), as well as a
planned expansion of Pfizer’s MAP sterile injectable pharmaceutical
production facility in Kalamazoo, 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,
including the risk that final results from EPIC-SR could differ
from the interim 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-PEP
trial; 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 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 that may be pending or
filed (including a potential new drug application submission in the
U.S. and 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; risks related
to the ability to realize the anticipated benefits of the planned
investments and the ability to complete the expansions and begin
production in the anticipated timeframe or at all; other business
effects, including the effects of industry, market, economic,
political or regulatory conditions; 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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