- Company has 89 pipeline projects spread across 6 targeted
therapeutic areas with 4 programs in registration and 23 in Phase
3
- 27 key programs highlighted, including assets that could
potentially contribute revenue by 2025 and others in the 2026-2028
time frame
- Pipeline contributes to the Company’s expectation of at least
6% revenue CAGR over the next five years – and delivery of
longer-term topline growth beyond that period
- Major revenue contributions through 2025 anticipated from
Oncology, Vaccines, Rare Disease and Inflammation and
Immunology
- New stability, immunogenicity, and tolerability data for
COVID-19 vaccine candidate, BNT162b2, presented
As part of a two-day virtual Investor Day, Pfizer Inc. (NYSE:
PFE) provided an extensive overview of pipeline advances and shared
updates on the Company’s efforts to battle the COVID-19 pandemic on
multiple fronts, including new data on the BNT162b2 vaccine
candidate being developed in collaboration with BioNTech SE. The
pipeline updates contribute to the Company’s expectation of at
least a 6% revenue CAGR over the next five years, as well as
delivery of longer-term topline growth beyond that period.
Pfizer’s goal of delivering up to 25 breakthroughs to patients
by the year 2025 has 38 such opportunities to draw from as of
today, including the company’s 20-valent pneumococcal conjugate
vaccine candidate (20vPnC). On a non-risk adjusted basis, these
opportunities collectively represent more than $15 billion
(excluding 20vPnC) in potential incremental revenue for Pfizer from
2020 to 2025, as well as aggregate peak annual sales potential of
$35 billion to $40 billion (including 20vPnC). If successful, the
Company’s COVID-19 programs would be incremental to these
estimates.
“Pfizer’s purpose – Breakthroughs that change patients’ lives –
has never been more relevant, and our R&D pipeline has never
been more dynamic,” said Dr. Albert Bourla, Pfizer Chairman and
CEO. “I am proud of the truly transformational science that our
research and clinical teams are bringing to the fight against
disease, as well as the unprecedented speed with which we are
advancing our clinical programs in the battle against COVID-19. In
the coming months and years, I look forward to the new Pfizer
continuing to demonstrate the agility and innovative spirit of a
biotech combined with the scale of Big Pharma. With the depth and
breadth of our current portfolio, the tremendous potential of our
pipeline and scientific engine, and the power of our culture of
innovation, we are poised to continue delivering meaningful value
to patients by addressing some of the world’s most difficult health
challenges.”
UPDATES ON COVID-19 DEVELOPMENT PROGRAMS
Pfizer announced several key advances in its efforts to protect
humankind from the COVID-19 pandemic and prepare the pharmaceutical
industry to better respond to future global health crises.
BNT162 mRNA-based Vaccine Program
Pfizer and BioNTech shared several updates from their BNT162
mRNA-based vaccine program against SARS-CoV-2, the virus that
causes COVID-19 disease, including:
- Additional information on the BNT162b2 vaccine candidate,
including new stability data that supports the storage of vials at
refrigerated (2-8 °C) conditions for up to 5 days at the
administration point of use locations.
- Phase 1 immunogenicity data for the BNT162b2 candidate at two
weeks post second dose (35 days) provide additional data that
neutralizing geometric mean titers remain higher than that of a
panel of human SARS-CoV-2 convalescent sera, building on data
previously shared by the companies.
- Limited blinded tolerability data from the ongoing Phase 3
trial, confirming the mostly mild to moderate tolerability profile
as was observed in Phase 1. In the blinded data presented, 50% of
trial participants received placebo and 50% received BNT162b2.
- Submission of an amended protocol to the FDA for the Phase 3
pivotal trial to expand recruitment to approximately 44,000
participants that allows for the enrollment of new populations.
Enrollment in the trial has been proceeding as planned with current
enrollment at more than 29,000. Based on current infection rates,
the companies continue to expect that a conclusive readout on
efficacy is likely by the end of October.
Protease Inhibitor Program
The company announced the initiation of its Phase 1b clinical
trial to evaluate the safety of a novel investigational therapeutic
for COVID-19, PF-07304814. Of note,
- The Phase 1b study is a double-blind, placebo-controlled
clinical trial evaluating the safety, tolerability and
pharmacokinetics of PF-07304814, a phosphate prodrug that when
administered intravenously is metabolized to the active compound
PF-00835321, shown to be a very potent inhibitor of the SARS-Cov2
3CL protease in preclinical studies. The start of this clinical
study is supported by preclinical data conducted in collaboration
with leading academic collaborators and demonstrates the anti-viral
activity of this potential first-in-class SARS-CoV-2 therapeutic
designed specifically to address COVID-19. Two manuscripts
describing the preliminary preclinical data are currently available
on preprint servers at Link and Link; both manuscripts are
concurrently undergoing scientific peer review for potential
publication.
THERAPEUTIC AREAS OF FOCUS
Pfizer shared significant research advances across its various
therapeutic areas including candidates with blockbuster potential
expected to launch by 2025.
Vaccines
In addition to the COVID-19 vaccine program, Pfizer aims to
deliver five innovative vaccines by 2025, subject to clinical
success and regulatory approval. Updates on these late-stage
clinical development programs include:
- New data for 20vPNC from a pediatric Phase 2 proof-of-concept
study starting at two months of age describing safety and
immunogenicity in a four-dose series. 20vPnC showed a safety and
tolerability profile that was similar to Prevnar 13® Pneumococcal
13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]. Based on
the acceptable safety profile and the favorable immune response
data, including the 4th dose response data, Pfizer received
Breakthrough Therapy Designation. Full results will be presented as
part of ID Week’s virtual 2020 medical congress in October 2020,
and a Phase 3 program for 20vPnC in infants is ongoing.
- A Phase 2 proof-of-concept study of Pfizer’s potential
first-in-class pentavalent meningococcal vaccine candidate (Penta;
MenABCWY). The results demonstrated that Penta immune responses
were robust and noninferior to licensed meningococcal vaccines
(MenB and MenACWY) in individuals 10-25 years of age, regardless of
prior MenACWY exposure. Noninferiority of each Penta dose was
demonstrated across serogroups one month after the second dose for
Penta and MenB, and one month after the first dose for Penta and
MenACWY. Penta was well tolerated. Detailed results from this study
will be presented as part of ID Week’s virtual 2020 medical
congress in October 2020, and a Phase 3 trial in adolescents and
young adults is ongoing.
- An update on Pfizer’s potential first-in-class maternal vaccine
candidate for the prevention of respiratory syncytial virus
(RSVpreF). Clinical Phase 1/2 study results demonstrated never
before observed fold rises of RSV neutralizing antibodies; a fold
rise of 15.2 for RSV A and 18.0 for RSV B in women of childbearing
age one month post-immunization, compared with the fold rises of
2-3 seen with post-fusion or insufficiently stabilized forms. Using
these data, the Company applied modelling to predict potential
efficacy for RSVpreF; based on the model’s output, the
investigational vaccine RSVpreF has a high probability to
demonstrate meaningful efficacy in newborns when administered to
pregnant women. A Phase 3 trial is ongoing.
Rare Disease
Pfizer’s Rare Disease late-stage pipeline currently includes
three gene therapy programs that, if successful, are expected to
gain regulatory approval by the end of 2023, with an additional
pipeline of 10 preclinical initiatives that are at various stages
of maturity. Key updates include:
- Data from the Phase 1b DMD gene therapy program, including data
from an additional nine boys, who were all administered the high
dose of the investigational therapy. A total of 15 boys have now
been treated with the high dose and 18 boys have been treated
overall.
- No Serious Adverse Events (SAE) were observed among the nine
additional boys who were treated using a modified immunomodulatory
regimen and monitoring regimen. The prophylactic steroid treatment
was also changed from 1 mg/kg to an intermediate dose of
2mg/kg.
- Three of the nine boys were dosed with gene therapy product
that was manufactured using the commercial manufacturing process
developed at Pfizer’s facility in Sanford, North Carolina.
- Based on these data, the Company plans to initiate the pivotal
study in the next several weeks, with the plan to perform an
interim analysis of the clinical data in 2022.
- For the Hemophilia B gene therapy program, the Company shared
data from the Phase 1/2 study of fidanocogene elaparvovec, which
demonstrated sustained expression of Factor IX activity in the ~20%
of normal range at the four-year time point when administered at a
dose of 5E11 vg/kg.
- These data represent the longest period of durability observed
to date by a gene therapy for hemophilia B patients.
- Importantly, the mean annualized bleed rates (ABR) and the
annualized infusion rates remained significantly reduced in these
treated patients.
- Given the encouraging safety and efficacy profile, the Company
initiated a Phase 3 study in 2019 and the prospective lead-in study
with 40 patients has now been fully enrolled.
- The Company currently plans to perform an interim analysis with
20 patients and 12 months of ABR in 2021.
- Given the sustained functional factor levels and the ABR rates
that have been observed over a four-year period in the Phase 1/2
study, the Company believes that fidanacogene elaparvovec has the
potential to be a best-in-class therapy for hemophilia B
patients.
- For the Hemophilia A gene therapy program, an additional four
months of expression data were presented for giroctocogene
fitelparvovec showing sustained FVIII activity levels reflecting a
mean of approximately 71% between weeks 9 and 52 in patients
treated with a dose of 3E13 vg/kg of the viral vector. Patients
with data beyond 52 weeks show consistent FVIII levels.
Importantly, there have been no bleeds with this treated cohort.
Patients are currently being enrolled in a Phase 3 lead-in study
with plans to dose the first patient later this year.
Oncology
Pfizer’s Oncology pipeline has the potential to deliver up to 14
approvals expected by the end of 2025 and the potential for 24 new
molecular entities in the clinic by the end of 2021. Key updates
included, for the first time, early-stage opportunities obtained
from the 2019 acquisition of Array BioPharma:
- Two novel programs from the former Array BioPharma labs in
Boulder, Colorado, have begun enrollment of first-in-human trials:
a novel selective AXL/MERTK inhibitor as well as a brain-penetrant
V600X BRAF inhibitor.
- Pre-clinical data for AXL/MERTK support durable anti-tumor
immunity, both as a single agent and in combination with checkpoint
inhibition.
- For the brain penetrant BRAF inhibitor, pre-clinical studies
have shown that the molecule matches the anti-tumor activity of
encorafenib in treating systemic disease and demonstrates superior
activity in eradicating intracranial tumor implants. This molecule,
in combination with binimetinib, has the potential, if successful,
to represent a significant advancement over standard of care
regimens in melanoma and other BRAF-driven cancers.
- Two additional next-generation targeted oncology programs from
the Boulder labs take aim at HER2-Exon 20 and cMET-Exon 14; both
programs are expected to enter the clinic in 2021.
- Encouraging activity was presented from a Phase 2 single-arm
study of encorafenib, binimetinib plus cetuximab in previously
untreated BRAFV6000E-mutant metastatic colorectal cancer (CRC). The
majority of patients benefited from this combination with a high
response rate of 50% and a disease control rate of 85 percent.
These data provided a proof-of-concept to initiate a 3-arm Phase 3
clinical study BREAKWATER that is planned to start later this
year.
- Pfizer also underscored several potential first-in-class or
best-in-class programs, such as selective CDK2 and CDK4 inhibitors,
as well as data for a BCMA-targeted bispecific antibody for the
treatment of multiple myeloma, a HER2-Antibody Drug Conjugate for
the treatment of breast cancer and other HER2-expressing cancers.
- In a Phase 1 trial, more than 50 patients have now been treated
with BCMA, with encouraging responses so far, including stringent
complete responses, and responses in several patients who had
previously experienced other BCMA-targeting agents. Pfizer's BCMA
is administered subcutaneously, which has significantly reduced the
incidence and grade of cytokine release syndrome and is more
convenient for patients and physicians.
- Clinical testing with the HER2-ADC began in 2017, and to date a
very impressive response rate in HER2+ breast and gastrointestinal
cancers has been observed in a Phase 1 trial, including in many
patients who had previously been treated with T-DM1. Pfizer’s
HER2-ADC is highly differentiated from other HER2-ADCs with a very
stable site-specifically conjugated cell-permeable auristatin
payload that yields a molecule with the potential for an improved
safety and potency profile.
Inflammation and Immunology
The Inflammation & Immunology pipeline is focused on
patients with autoimmune and chronic inflammatory diseases across
rheumatology, gastroenterology and dermatology, with five distinct
immuno-kinases, in oral and topical formulations, studied for
potential treatment of 10 diseases, and three additional novel
biologics in Phase 2 studies. Key updates included:
- Phase 2 data were presented from a proof-of-concept study for
topical brepocitinib (dual TYK2/JAK1 inhibitor) in patients with
mild-to-moderate atopic dermatitis. A Phase 2a randomized,
placebo-controlled study to evaluate efficacy and safety of topical
brepocitinib in 292 patients with mild-to-moderate atopic
dermatitis showed strong dose-dependent efficacy with 42% of those
treated with the 3% once-daily brepocitinib topical achieving at
least a 90% or greater change from baseline in their Eczema Area
and Severity Index (EASI-90) score by week six. The most frequent
treatment-emergent adverse events were nasopharyngitis and atopic
dermatitis.
- Safety and efficacy data from the JADE COMPARE study for
abrocitinib and dupilumab compared to placebo in adults on
background topical therapy. Abrocitinib 200 mg demonstrated
statistically superior improvement in severity of pruritus (itch)
compared to dupilumab at week two, a key secondary endpoint. After
two weeks of therapy, 15% of patients on abrocitinib 200 mg had
resolution of itch (PRNS Score 0 or 1). Safety was consistent with
published data. These results, together with results from JADE
MONO-1 and JADE MONO-2, support the regulatory filing for
abrocitinib submitted in August 2020, with potential for U.S.
approval in 2021.
Internal Medicine
The Internal Medicine pipeline addresses the increasing global
burden of cardiometabolic disease, with nine investigational
medicines in active clinical studies and additional therapies in
the pre-clinical pipeline. Key updates included:
- Phase 2a data for the potential first-in-class combination of
clesacostat (PF-05221304), an investigational acetyl-CoA
carboxylase inhibitor (ACCi), and ervogastat (PF-06865571), an
investigational diacylglycerol acyltransferase 2 inhibitor
(DGAT2i), for the treatment of non-alcoholic steatohepatitis
(NASH). The six-week study found that the co-administration of
clesacostat/ervogastat demonstrated a statistically significant
reduction from baseline in liver fat (-40.13%) compared to placebo
(8.14%) in participants with nonalcoholic fatty liver disease
(NAFLD) and was safe and well-tolerated. These results were
presented in August at the Digital International Liver Congress
2020. Pfizer has progressed both ervogastat monotherapy and the
clesacostat/ervogastat combination into a Phase 2b liver biopsy
study, and the results of this study will guide which candidate or
combination is progressed to Phase 3.
- Clinical data and development plans for vupanorsen, an
investigational antisense oligonucleotide to reduce ANGPTL3, a
genetically-validated target for lipid and cardiovascular risk
reduction. The team shared results from a Phase 2a study that was
conducted by Akcea Therapeutics/Ionis Pharmaceuticals and
previously disclosed at the recent European Society of Cardiology
Congress 2020. The study met its primary endpoint, with vupanorsen
demonstrating significant triglyceride lowering from baseline of
-33.2%, -63.1%, -53.8% and -50.4% at doses of 10, 20, 40 and 60 mg,
respectively, compared to a placebo reduction of -11.4% in
participants with hypertriglyceridemia, type 2 diabetes and NAFLD.
Vupanorsen also demonstrated a favorable safety and tolerability
profile in this study. Pfizer is leading further development of
vupanorsen, with a focus on cardiovascular risk reduction, and
plans to initiate a Phase 2b dose-ranging study in the coming
weeks.
- Phase 1 data and development plans for danuglipron
(PF-06882961), which has the potential to be the first-ever small
molecule oral GLP-1RA for treating obesity and type 2 diabetes. In
the four-week Phase 1 study, which was previously presented at the
American Diabetes Association Scientific Sessions in June 2020,
danuglipron demonstrated robust reductions in fasting plasma
glucose of -66.6, -80.6 and -89.7 mg/dL at doses of 15, 70 and 120
mg respectively, compared to a -24.8 mg/dL reduction for placebo.
Danuglipron also reduced HbA1c by -0.9, -1.2 and -1.2% at doses of
15, 70 and 120 mg respectively, compared to a -0.4% reduction for
placebo treated subjects. The higher doses of danuglipron reduced
body weight by -4.0 kg (70 mg) and -7.9 kg (120 mg) relative to a
-1.9 kg change in the placebo arm. Danuglipron was well tolerated
in this study with an adverse event profile consistent with the
GLP-1 class. Pfizer has initiated a Phase 2 study for danuglipron
in type 2 diabetes and plans to initiate a second Phase 2 study in
obesity in the fourth quarter of 2020.
To access a replay of the webcast, including audio, video and
presentation slides, visit our web site at
www.pfizer.com/investors.
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 150 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 September 15, 2020. Pfizer assumes no obligation
to update forward-looking statements contained in this release or
the webcast as the result of new information or future events or
developments.
This release and the webcast contain forward-looking information
about Pfizer’s anticipated operating and financial performance,
business plans and prospects, Pfizer’s pipeline portfolio
(including anticipated regulatory submissions, data read-outs,
study starts, approvals, revenue contributions and market
opportunities), and our efforts to respond to COVID-19, including
our investigational vaccine candidate against SARS-CoV-2 and our
investigational protease inhibitor, including their potential
benefits, among other things, that are subject to 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 our clinical trials, regulatory submission
dates, regulatory approval dates and/or launch dates, as well as
the possibility of unfavorable new clinical data and further
analyses of existing clinical data; risks associated with interim
and preliminary data; the risk that clinical trial data are subject
to differing interpretations and assessments by regulatory
authorities; whether regulatory authorities will be satisfied with
the design of and results from our clinical studies; whether and
when any drug applications, biologics license applications and/or
emergency use authorization applications may be filed in any
jurisdictions for any potential indication for Pfizer’s product
candidates; whether and when any such applications that may be
filed for any of Pfizer’s product candidates may be approved by
regulatory authorities, 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 any such product
candidates will be commercially successful; decisions by regulatory
authorities impacting labeling, manufacturing processes, safety
and/or other matters that could affect the availability or
commercial potential of Pfizer’s product candidates, including
development of products or therapies by other companies;
manufacturing capabilities or capacity; uncertainties regarding the
ability to obtain recommendations from vaccine technical committees
and other public health authorities and uncertainties regarding the
commercial impact of any such recommendations; 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, 2019 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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Media Relations:
Amy Rose +1 (646) 592-3157 Amy.Rose@Pfizer.com
Investor Relations: Chuck
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