- Six Late-Stage Programs with Peak Revenue Potential of $10B
- $20B1 Poised to Deliver Sustainable Growth
- Expected Phase 3 Data Readouts in 2025 for Oveporexton
(TAK-861), Zasocitinib (TAK-279) and Rusfertide (TAK-121)
- Regulatory Filings for Oveporexton (Narcolepsy Type 1),
Zasocitinib (Psoriasis) and Rusfertide (Polycythemia Vera) on Track
for Fiscal Years 2025 - 2026
- Five Additional Filings Anticipated in Fiscal Years 2027 -
2029 Including First Indication Submissions for Mezagitamab
(TAK-079), Fazirsiran (TAK-999) and Elritercept (TAK-226)
Takeda (TSE:4502/NYSE:TAK) will host an
investor R&D Day today beginning at 8:30 a.m. JST in Tokyo. The
meeting will focus on programs in the company’s late-stage
pipeline, the transformative value they could deliver to patients,
and the market opportunities they represent.
“We are focused on advancing our innovative pipeline and
accelerating late-stage programs to deliver sustainable revenue
growth to 2030 and beyond, building upon the strong momentum of our
Growth and Launch Products,” said Christophe Weber, Takeda chief
executive officer. “The first three Phase 3 programs will read out
in 2025, initiating a cadence of potential filings across multiple
indications over the next several years.”
Eight Regulatory Filings in FY2025 – FY2029 The
late-stage pipeline includes oveporexton (TAK-861), zasocitinib
(TAK-279), rusfertide (TAK-121), mezagitamab (TAK-079), fazirsiran
(TAK-999) and elritercept (TAK-226). Combined these programs have
potential peak revenue1 of $10B - $20B. Data from three Phase 3
programs is expected to read out in 2025:
- oveporexton, a potential best-in-class and first-in-class
investigational oral orexin receptor 2 agonist will report Phase 3
results in narcolepsy type 1;
- zasocitinib, an investigational next-generation, highly
selective and potent oral allosteric tyrosine kinase 2 (TYK2)
inhibitor will deliver Phase 3 results in psoriasis; and
- rusfertide, an investigational injectable hepcidin mimetic in
development with partner Protagonist Therapeutics, will have Phase
3 results in polycythemia vera.
Filings for these three indications are expected in fiscal years
2025 and 2026. Five additional indication filings for late-stage
programs are on pace for fiscal years 2027 through 2029:
- zasocitinib in psoriatic arthritis;
- mezagitamab, an investigational anti-CD38 antibody providing
rapid, selective and sustained depletion of disease-causing immune
cells that could set a new standard for the treatment of immune
thrombocytopenia (ITP) and immunoglobulin A neuropathy (IgAN);
- fazirsiran, an investigational RNA interference (RNAi) therapy
that stops the production of misfolded abnormal protein Z-AAT
directly addressing the pathology of alpha-1 antitrypsin deficiency
liver disease (AATD-LD) and;
- elritercept, an investigational activin inhibitor designed to
treat anemia associated with certain hematologic cancers, including
myelodysplastic syndromes (MDS). Takeda recently signed an
exclusive licensing agreement with Keros Therapeutics to further
develop, manufacture and commercialize elritercept worldwide
outside of mainland China, Hong Kong and Macau. The agreement is
subject to customary closing conditions, including completion of
antitrust reviews.
“Takeda has established an exciting, late-stage pipeline of
transformative therapies that we believe will deliver value to our
company and, most importantly, to the patients we serve around the
world,” said Andy Plump, president of R&D at Takeda. “As we
continue scaling our capabilities and maximizing R&D investment
to deliver the late-stage pipeline, we are also progressing an
exciting early-stage pipeline, supporting a cutting-edge research
organization, and focusing on creative business development across
our therapeutic areas to sustain Takeda’s future and continue to
meet significant unmet patient needs.”
2024 R&D Day Agenda The meeting includes the
following presentations and speakers:
A Global, Innovation-Driven Biopharmaceutical Company
Christophe Weber, President & CEO
R&D Strategy and Pipeline Highlights Andy Plump,
President, Research and Development
Neuroscience: Deep-Dive on Orexin Franchise Sarah Sheikh,
Head of Neuroscience Therapeutic Area Unit and Head of Global
Development Ramona Sequeira, President of Global Portfolio
Division
Gastrointestinal and Inflammation: Deep-Dive on Zasocitinib,
Rusfertide, Mezagitamab, Fazirsiran Chinwe Ukomadu, Head of
Gastrointestinal and Inflammation Therapeutic Area Unit Ramona
Sequeira, President of Global Portfolio Division
Oncology: Deep-Dive on Elritercept – Newly Announced Business
Development Deal Teresa Bitetti, President Global Oncology
Business Unit P.K. Morrow, Head of Oncology Therapeutic Area
Unit
Webcast Details A live webcast of the meeting begins at
8:30 a.m. JST December 13 (6:30 p.m. EST December 12).
Presentations are available on the Investor Relations section of
Takeda’s website where a video replay will be available
following the meeting.
About Takeda Takeda is focused on creating better health
for people and a brighter future for the world. We aim to discover
and deliver life-transforming treatments in our core therapeutic
and business areas, including gastrointestinal and inflammation,
rare diseases, plasma-derived therapies, oncology, neuroscience and
vaccines. Together with our partners, we aim to improve the patient
experience and advance a new frontier of treatment options through
our dynamic and diverse pipeline. As a leading values-based,
R&D-driven biopharmaceutical company headquartered in Japan, we
are guided by our commitment to patients, our people and the
planet. Our employees in approximately 80 countries and regions are
driven by our purpose and are grounded in the values that have
defined us for more than two centuries. For more information, visit
www.takeda.com.
Important Notice For the purposes of this notice, “press
release” means this document, any oral presentation, any question
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regarding this release. This press release (including any oral
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forward-looking statements are based on assumptions about many
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actual results to differ materially from those expressed or implied
by the forward-looking statements: the economic circumstances
surrounding Takeda’s global business, including general economic
conditions in Japan and the United States; competitive pressures
and developments; changes to applicable laws and regulations,
including global health care reforms; challenges inherent in new
product development, including uncertainty of clinical success and
decisions of regulatory authorities and the timing thereof;
uncertainty of commercial success for new and existing products;
manufacturing difficulties or delays; fluctuations in interest and
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efficacy of marketed products or product candidates; the impact of
health crises, like the novel coronavirus pandemic, on Takeda and
its customers and suppliers, including foreign governments in
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business; the timing and impact of post-merger integration efforts
with acquired companies; the ability to divest assets that are not
core to Takeda’s operations and the timing of any such
divestment(s); and other factors identified in Takeda’s most recent
Annual Report on Form 20-F and Takeda’s other reports filed with
the U.S. Securities and Exchange Commission, available on Takeda’s
website at:
https://www.takeda.com/investors/sec-filings-and-security-reports/
or at www.sec.gov. Takeda does not undertake to update any of the
forward-looking statements contained in this press release or any
other forward-looking statements it may make, except as required by
law or stock exchange rule. Past performance is not an indicator of
future results and the results or statements of Takeda in this
press release may not be indicative of, and are not an estimate,
forecast, guarantee or projection of Takeda’s future results.
Peak Sales and PTRS Estimates References in this press
release to peak revenue potential ranges are estimates that have
not been adjusted for probability of technical and regulatory
success (PTRS) and should not be considered a forecast or target.
These peak revenue potential ranges represent Takeda’s assessments
of various possible future commercial scenarios that may or may not
occur.
References in this press release to PTRS are to internal
estimates of Takeda regarding the likelihood of obtaining
regulatory approval for a particular product in a particular
indication. These estimates reflect the subjective judgment of
responsible Takeda personnel and have been approved by Takeda’s
Portfolio Review Committee for use in internal planning.
Medical Information This press release contains
information about products that may not be available in all
countries, or may be available under different trademarks, for
different indications, in different dosages, or in different
strengths. Nothing contained herein should be considered a
solicitation, promotion or advertisement for any prescription drugs
including the ones under development.
Elritercept license agreement Elritercept is included for
reference only. Takeda entered into an exclusive license agreement
with Keros for global rights, in all territories outside of
mainland China, Hong Kong and Macau, to Elritercept. The closing of
the transaction is subject to receipt of regulatory approval(s),
expected in the first calendar quarter of 2025. Takeda does not
currently have rights to Elritercept.
___________________________ 1 References in
this presentation to peak revenue potential are estimates that have
not been adjusted for probability of technical and regulatory
success (PTRS) and should not be considered a forecast or target.
These peak revenue ranges represent Takeda’s assessments of various
possible future commercial scenarios that may or may not occur.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241211148492/en/
Investor Relations Christopher O’Reilly
Christopher.oreilly@takeda.com +81 (0) 90-6481-3412 Takeda Media
Relations media_relations@takeda.com
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