TAK Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of)

17.44
-0.46  -3%
Previous Close 17.9
Open 17.5
52 Week Low 12.43
52 Week High 20.42
Market Cap $54,529,858,536
Shares 3,126,712,072
Float 3,126,712,072
Enterprise Value $95,258,014,718
Volume 4,118,724
Av. Daily Volume 1,811,501
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Upcoming Catalysts

Drug Stage Catalyst Date
Cabozantinib
Medullary Thyroid Cancer
Phase 3
Phase 3
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Pevonedistat (TAK-924)
Higher-risk myelodysplastic syndromes (HR-MDS)
Phase 3
Phase 3
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TAK-721
Eosinophilic esophagitis
PDUFA priority review
PDUFA priority review
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TAK-831 / NBI-1065844
Negative symptoms of schizophrenia
Phase 2
Phase 2
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CABOMETYX (cabozantinib) + atezolizumab (TECENTRIQ) - (COSMIC-312)
Hepatocellular Carcinoma
Phase 3
Phase 3
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TAK-994
Narcolepsy
Phase 2
Phase 2
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TAK-755
Congenital Thrombotic Thrombocytopenic Purpura
Phase 3
Phase 3
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Cabozantinib and Nivolumab and Ipilimumab (COSMIC-313)
Renal Cell Carcinoma
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
TAK-653 / NBI-1065845
Treatment-resistant depression
Phase 2
Phase 2
Phase 2 trial planned for 2021.
TAK-041 / NBI-1065846
Anhedonia in depression
Phase 2
Phase 2
Phase 2 trial planned for 2021.
CB-839 + Cabozantinib (CANTATA)
Renal cell carcinoma
Phase 2
Phase 2
Phase 2 top-line data did not meet primary endpoint - January 4, 2020.
TAK-609
Hunter Syndrome
NDA Filing
NDA Filing
Currently in preparatory stages for a NDA submission - noted July 31, 2020.
Cabozantinib - COSMIC-311
Thyroid Carcinoma
Phase 3
Phase 3
Phase 3 trial met co-primary endpoint of improvement in progression-free survival.
Ponatinib
Chronic Myeloid Leukemia
Approved
Approved
FDA approval announced December 18, 2020.
TAK-935/OV935 (ELEKTRA)
Dravet Syndrome / Lennox-Gastaut Syndrome
Phase 2
Phase 2
Phase 2 primary endpoint met. Statistically significant reduction in Dravet syndrome patients. Lennox-Gastaut syndrome cohort was not statistically significant - August 25, 2020.
TAK-620 (maribavir)
Cytomegalovirus (CMV)
Phase 3
Phase 3
Phase 3 trial met primary endpoint - December 4, 2020.
CoVIg-19
COVID-19
Phase 3
Phase 3
Phase 3 trial initiation announced October 9, 2020.
Cenicriviroc + Otezla (apremilast) + Firazyr (icatibant)
COVID-19 (severe)
Phase 2
Phase 2
Phase 2 trial initiation announced August 3, 2020.
ALUNBRIG (brigatinib)
ALK+ Metastatic Non-Small Cell Lung Cancer
Approved
Approved
FDA Approval announced May 22, 2020.
Ixazomib - TOURMALINE-MM4
Multiple myeloma
Phase 3
Phase 3
Phase 3 trial met primary endpoint - November 8, 2019.
Vedolizumab
Crohn's Disease
Phase 3
Phase 3
Phase 3 trial met primary endpoint - July 22, 2020.
Entyvio
Ulcerative Colitis
CRL
CRL
CRL issued December 21, 2020.
NINLARO (ixazomib) lenalidomide and dexamethasone - TOURMALINE-MM2
Multiple myeloma
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - March 10, 2020.
Cabozantinib
Medullary thyroid cancer
Approved
Approved
Approved November 29, 2012.
Cabozantinib (CELESTIAL)
Advanced hepatocellular cancer (HCC)
Approved
Approved
FDA Approval announced January 14, 2019.
ADCETRIS
Hodgkin lymphoma and Anaplastic large cell lymphoma
Approved
Approved
Approval announced August 19, 2011.
ADCETRIS - AETHERA
Post-transplant Hodgkin lymphoma (HL) cancer
Approved
Approved
Approved August 17, 2015 under priority review.
ADCETRIS in combination with chemotherapy - ECHELON-2
Frontline CD30-positive mature T-cell lymphomas - cancer
Approved
Approved
FDA Approval announced November 16, 2018.
ADCETRIS in combination with chemotherapy ECHELON-1
Frontline Hodgkin lymphoma
Approved
Approved
sBLA approval announced March 20, 2018. PDUFA date under priority review was May 1, 2018.
ALUNBRIG versus alectinib ALTA 3
ALK+ Advanced NSCLC
Phase 3
Phase 3
Phase 3 trial is enrolling.
Mobocertinib (TAK-788)
Non-Small Cell Lung Cancer
Phase 1/2
Phase 1/2
Phase 1/2 trial has completed enrolment.
Mobocertinib (TAK-788) - EXCLAIM
non-small cell lung cancer (NSCLC)
Phase 2
Phase 2
Phase 2 trial has completed enrolment.
Mobocertinib EXCLAIM-2
NSCLC with EGFR exon 20 insertion mutations
Phase 3
Phase 3
Phase 3 trial is enrolling.

Latest News

  1. Goal to Reach JPY5 Trillion ($47 Billion) Revenue by FY20301, Representing 50% Growth from FY2019

    Wave 1 Pipeline Portfolio Includes 12 New Molecular Entities Targeted for Launch by FY2024 Representing Best-in-Class/First-in-Class Therapies with Significant Market Potential

    Rapid Deleveraging On Track to Achieve Target of 2x Net Debt / adjusted EBITDA within Fiscal Years 2021 to 2023

    Takeda Pharmaceutical Company Limited ((TAK) ("Takeda") provided an update on the progress of its continued transformation and growth today at the virtual 39th Annual J.P. Morgan Healthcare Conference. President and Chief Executive Officer, Christophe Weber, shared details on Takeda's portfolio and pipeline strategy and financial outlook, including key…

    Goal to Reach JPY5 Trillion ($47 Billion) Revenue by FY20301, Representing 50% Growth from FY2019

    Wave 1 Pipeline Portfolio Includes 12 New Molecular Entities Targeted for Launch by FY2024 Representing Best-in-Class/First-in-Class Therapies with Significant Market Potential

    Rapid Deleveraging On Track to Achieve Target of 2x Net Debt / adjusted EBITDA within Fiscal Years 2021 to 2023

    Takeda Pharmaceutical Company Limited ((TAK) ("Takeda") provided an update on the progress of its continued transformation and growth today at the virtual 39th Annual J.P. Morgan Healthcare Conference. President and Chief Executive Officer, Christophe Weber, shared details on Takeda's portfolio and pipeline strategy and financial outlook, including key programs expected to contribute to the company's revenue growth over the next decade.

    "In 2020, Takeda demonstrated the resilience of our business model, the depth of our portfolio and the commitment of our employees as we continued to serve patients and communities globally while overcoming challenges posed by the COVID-19 pandemic," said Christophe Weber, Takeda president and chief executive officer. "As a values-based and R&D-driven biopharmaceutical company celebrating 240 years in 2021, we remain focused on bringing life-transforming treatments to patients worldwide by delivering on our highly innovative pipeline and our continued commitment to patients, our people and the planet."

    Highly Innovative Pipeline Supports Sustained Growth

    Takeda has built a world-class, state-of-the-art, externally-facing R&D engine and has generated an innovative and modality diverse pipeline of approximately 40 clinical-stage new molecular entities (NMEs). Takeda's pipeline portfolio has the potential to contribute significantly to revenue growth and the company has a goal to reach JPY5 trillion ($47 billion) revenue by FY20301, representing 50% growth from FY2019.

    The majority of revenue growth is expected to come from the company's Wave 1 pipeline, which includes 12 unique NMEs, representing potential best-in-class/first-in-class therapies and its existing 14 global brands.

    Takeda's Wave 1 programs include five that have received a Breakthrough Therapy designation and three that were granted fast track designation by the U.S. Food and Drug Administration (FDA). In addition, one program was designated under the SAKIGAKE Designation System by the Japanese Ministry of Health, Labour and Welfare and another program was the first breakthrough designation granted by the Chinese Food and Drug Administration to a multinational biopharmaceutical company. Twelve pivotal milestones, including five pivotal data readouts, are expected through fiscal year 2022 with additional near-term development milestones expected across all Wave 1 programs.

    Beyond the Wave 1 pipeline, Takeda's research engine, which comprises internal research capabilities and more than 200 active partnerships, is rapidly advancing a steady stream of next-generation therapies in Wave 2 of our pipeline that will provide sustained growth in FY2025 and beyond. These Wave 2 early-clinical and preclinical programs are designed to provide transformative or curative potential for targeted populations with high unmet need across core therapeutic areas. They are based on targets with strong human validation, represent diverse modalities and leverage new platform capabilities in cell therapy, gene therapy and data sciences.

    Key Wave 1 Pipeline Assets Have Significant Market Potential

    TAK-003

    Takeda's tetravalent dengue vaccine candidate (TAK-003) has the potential to help address the massive global burden of dengue including key priorities for dengue control such as protection of seronegative individuals (persons not previously exposed to dengue) and prevention of hospitalization. TAK-003 is based on a live-attenuated dengue serotype 2 virus, which provides the genetic "backbone" for all four vaccine viruses. The TAK-003 development program includes the pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES), a double-blind, randomized, placebo-controlled trial evaluating the safety and efficacy of two doses of TAK-003 in the prevention of laboratory-confirmed symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in children and adolescents. The TIDES trial is continuing, and safety and efficacy will be assessed over a total of four and a half years. Dengue is the fastest spreading mosquito-borne viral disease and was recognized by WHO to be one of the top ten threats to global health in 2019. Approximately half of the world's population now lives under the threat of dengue, which is estimated to cause 390 million infections each year.

    TAK-755

    Takeda's TAK-755 has the potential to be a transformative therapy for thrombotic thrombocytopenic purpura (TTP), a rare and life-threatening clotting disorder defined by low or absent circulating ADAMTS13 activity (an enzyme essential for regulation of normal blood clotting). There is very high unmet need for new therapies for both congenital and immune-mediated TTP, and TAK-755 is the first and only ADAMTS13 replacement therapy currently in development for both types of TTP. If approved, TAK-755 could be the only replacement therapy to rapidly and completely correct ADAMTS13 levels, and positively impact morbidity and mortality. If approved, TAK-755 has the potential to be first-in-class and the therapeutic choice for prophylaxis in congenital TTP, and a best-in-class therapy for the treatment of immune-mediated TTP. TAK-755 could simplify treatment, avoid adverse events related to plasma-derived therapy and plasma exchange, and provide the potential for at-home therapy. Data readouts are currently expected in 2021 for a phase 2 trial in immune-mediated TTP and in 2022 for a pivotal Phase 3 trial in congenital TTP.

    TAK-007

    Developed in collaboration with the University of Texas MD Anderson Cancer Center, Takeda's TAK-007 is a chimeric antigen receptor (CAR) natural killer (NK) cell therapy ‘armored' with IL-15 targeting CD19 positive B-cell malignancies. The vision is for TAK-007 to be an allogeneic therapy, meaning the NK cells are taken from a non-related healthy donor rather than the patient themselves. As a result, TAK-007 has the potential to be manufactured in advance and stored for off-the-shelf-use. MD Anderson's CAR-NK CD19 is being studied in a phase 1/2 trial in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL). In the ongoing phase 1/2 trial, CAR-NK therapy has not been associated with the severe cytokine release syndrome (CRS) or neurotoxicity observed with existing CAR-T cell therapies and has the potential to be administered in an outpatient setting. A TAK-007 pivotal study is expected to begin enrolling patients with relapsed or refractory B-cell malignancies in 2021. There are currently no approved CAR NK therapies and no allogeneic cell therapies approved to treat cancer.

    TAK-994 & TAK-925

    TAK-994 is the first oral selective orexin 2 receptor agonist to enter clinical development for the treatment of narcolepsy type 1 (NT1), a rare neurologic condition characterized by excessive daytime sleepiness, cataplexy (signs and symptoms of the disease) and is due to a loss of orexin producing neurons. TAK-994 is currently being evaluated in an ongoing Phase 2 clinical trial in narcolepsy (SPARKLE-1501). If approved, TAK-994 may be the first treatment to address the underlying biology of the disease. TAK-925 (IV formulation) has published proof-of-concept data in NT1, narcolepsy type 2 (NT2), and shift work sleep disorder. Data for idiopathic hypersomnia and obstructive sleep apnea will be disclosed in the future.

    Financial Strength

    Takeda is committed to maintaining investment grade credit ratings and remains on track towards its medium-term target of 2x Net Debt/adjusted EBITDA ratio within the fiscal years 2021 to 2023, with rapid de-leveraging driven by strong cash flow and proceeds from non-core asset divestitures. In the first half of FY2020, Takeda exceeded its $10B non-core asset divestiture target with 11 deals and up to ~$11.6 billion of non-core disposals announced since January 2019, while further de-leveraging in H1 FY2020 led to a 3.7x net debt/adjusted EBITDA ratio at the end of the period.

    Takeda has solid growth momentum and potential for accelerated underlying growth over the medium term. Takeda is also on track to achieve our targeted annual run rate of $2.3 billion in cost synergies by the end of FY2021, further supporting margin performance to meet its medium-term underlying core operating profit margin target in the mid-30s. Takeda remains committed to shareholder returns with a well-established dividend policy of 180 yen per share annually.

    Slides from the J.P. Morgan Healthcare Conference presentation and a link to the audio webcast can be accessed on Takeda's website at: https://www.takeda.com/investors/ir-events/.

    About Takeda Pharmaceutical Company Limited

    Takeda Pharmaceutical Company Limited ((TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetic and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries. For more information, visit https://www.takeda.com.

    Important Notice

    For the purposes of this notice, "press release" means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited ("Takeda") regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

    The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, "Takeda" is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words "we", "us" and "our" are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

    Forward-Looking Statements

    This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as "targets", "plans", "believes", "hopes", "continues", "expects", "aims", "intends", "ensures", "will", "may", "should", "would", "could" "anticipates", "estimates", "projects" or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause 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; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or 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 countries in which Takeda operates, or on other facets of its 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/ reports/sec-filings/ 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.

    Certain Non-IFRS Financial Measures

    This press release and materials distributed in connection with this press release include certain IFRS financial measures not presented in accordance with International Financial Reporting Standards ("IFRS"), such as Underlying Revenue, Core Operating Profit, Underlying Core Operating Profit, Core Net Profit, Underlying Core EPS, Net Debt, EBITDA, Adjusted EBITDA and Free Cash Flow. Takeda's management evaluates results and makes operating and investment decisions using both IFRS and non-IFRS measures included in this press release. These non-IFRS measures exclude certain income, cost and cash flow items which are included in, or are calculated differently from, the most closely comparable measures presented in accordance with IFRS. By including these non-IFRS measures, management intends to provide investors with additional information to further analyze Takeda's performance, core results and underlying trends. Takeda's non-IFRS measures are not prepared in accordance with IFRS and such non-IFRS measures should be considered a supplement to, and not a substitute for, measures prepared in accordance with IFRS (which we sometimes refer to as "reported" measures). Investors are encouraged to review the reconciliation of non-IFRS financial measures to their most directly comparable IFRS measures.

    Further information on certain of Takeda's Non-IFRS measures, including reconciliations to the most comparable measures presented under IFRS, is posted on Takeda's investor relations website at https://www.takeda.com/investors/reports/quarterly-announcements/

    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.


    1 Includes incremental revenues on a non-PTS (probability of technical success) basis (i.e., figures represent best case scenarios, including technical success that Takeda does not currently consider probable to occur and should not be seen as a forecast or target figure). On a PTS-adjusted basis, Takeda expects revenue CAGR to be in the low single digits between FY2019 and FY2030. Does not include any potential impacts imposed by the Most Favored Nation Model interim final rule issued by the U.S. Centers for Medicare & Medicaid Services (CMS) on November 20, 2020, which are currently being assessed.

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  2. Takeda Pharmaceutical Company Limited ((TAK) ("Takeda") will present virtually at the 39th Annual J.P. Morgan Healthcare Conference at 5:20 p.m. ET on Monday, January 11, 2021 / 7:20 a.m. JT on Tuesday, January 12, 2021. Investors and the general public are invited to listen to the live webcast with Christophe Weber, president and chief executive officer, here. A replay of the webcast will also be archived at the same location. A link to the webcast and slides for download will also be available on Takeda's website at https://www.takeda.com/investors/ir-events/.

    ABOUT TAKEDA PHARMACEUTICAL COMPANY LIMITED

    Takeda Pharmaceutical Company Limited ((TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed…

    Takeda Pharmaceutical Company Limited ((TAK) ("Takeda") will present virtually at the 39th Annual J.P. Morgan Healthcare Conference at 5:20 p.m. ET on Monday, January 11, 2021 / 7:20 a.m. JT on Tuesday, January 12, 2021. Investors and the general public are invited to listen to the live webcast with Christophe Weber, president and chief executive officer, here. A replay of the webcast will also be archived at the same location. A link to the webcast and slides for download will also be available on Takeda's website at https://www.takeda.com/investors/ir-events/.

    ABOUT TAKEDA PHARMACEUTICAL COMPANY LIMITED

    Takeda Pharmaceutical Company Limited ((TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetic and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries. For more information, visit https://www.takeda.com.

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  3. Takeda Pharmaceutical Company Limited ((TAK) ("Takeda") today announced the completion of its previously-announced sale of a portfolio of select prescription products to Cheplapharm for a total value of $562 million USD1. The portfolio includes 16 prescription pharmaceutical products sold predominantly in Europe which is part of Takeda's Europe and Canada Business Unit. This divestment agreement was first announced in September 2020.

    The divested portfolio is comprised of non-core prescription pharmaceutical products in a variety of therapeutic categories that includes Cardiovascular/Metabolic and Anti-Inflammatory products along with Calcium. In line with Takeda's long-term growth strategy, these products, while addressing key patient needs…

    Takeda Pharmaceutical Company Limited ((TAK) ("Takeda") today announced the completion of its previously-announced sale of a portfolio of select prescription products to Cheplapharm for a total value of $562 million USD1. The portfolio includes 16 prescription pharmaceutical products sold predominantly in Europe which is part of Takeda's Europe and Canada Business Unit. This divestment agreement was first announced in September 2020.

    The divested portfolio is comprised of non-core prescription pharmaceutical products in a variety of therapeutic categories that includes Cardiovascular/Metabolic and Anti-Inflammatory products along with Calcium. In line with Takeda's long-term growth strategy, these products, while addressing key patient needs in these countries, are outside of Takeda's five core business areas: Gastroenterology (GI), Rare Diseases, Plasma-Derived Therapies, Oncology and Neuroscience.

    Takeda remains focused on executing its long-term growth strategy to optimize our business mix around our key business areas, and simplifying our operations to better serve patients by delivering innovative treatments in these areas.

    The Company intends to use the proceeds from the sale to reduce its debt and accelerate deleveraging towards its target of 2x net debt/adjusted EBITDA within Fiscal Years 2021–2023.

    Takeda has sustained momentum in its divestiture strategy in 2020 and exceeded its $10 billion non-core asset divestiture target, announcing 11 deals since January 2019 to date for a total aggregate value of up to approximately $11.6 billion, including agreements to divest:

    • Takeda Consumer Healthcare Company Limited to Oscar A-Co KK, a company controlled by funds managed by The Blackstone Group Inc. and its affiliates for a total value of approximately JPY 242.0 billion ($2.3 billion USD).
    • Other non-core portfolio assets within the Growth & Emerging Markets Business Unit, totaling up to approximately $2.3 billion with five separate buyers.2
    • Select OTC and non-core assets in Europe to Orifarm for up to approximately $670 million.
    • The TachoSil Fibrin Sealant Patch to Corza Health, Inc. for approximately €350 million.

    About Takeda Pharmaceutical Company Limited

    Takeda Pharmaceutical Company Limited ((TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetic and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline.

    Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.

    For more information, visit https://www.takeda.com.

    Important Notice

    For the purposes of this notice, "press release" means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited ("Takeda") regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

    The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, "Takeda" is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words "we", "us" and "our" are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

    Forward-Looking Statements

    This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as "targets", "plans", "believes", "hopes", "continues", "expects", "aims", "intends", "ensures", "will", "may", "should", "would", "could" "anticipates", "estimates", "projects" or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause 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; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or 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 countries in which Takeda operates, or on other facets of its 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/reports/sec-filings/ 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.

    1 Based on the agreed price of 475 million EUR, and exchange rate at the time of the agreement in September 2020

    2 Includes agreement with Hasten Biopharmaceutic (China) for the sale of non-core products in China, Hypera S.A. for the sale of select non-core products in Latin America which remain subject to close; and, completed sales of non-core assets in the Russia-CIS region to STADA, the Near East, Middle East and Africa region to Acino, and Asia Pacific to Celltrion Inc.

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  4. Takeda continues to execute on global strategy focused on life-transforming treatments for patients living with complex and rare diseases

    Fast tracks innovative medicines to patients in China in key business areas

    Takeda Pharmaceutical Company Limited ((TAK) ("Takeda") today announced that it has entered into an agreement to divest a portfolio of non-core prescription pharmaceutical products sold in China to Hasten Biopharmaceutic Co., Ltd. (China) ("Hasten"), a company funded by Feidong County of Hefei City, China and established by Ray Capital Management Limited ("Ray Capital")1 Takeda will receive $322 million USD, subject to customary legal and regulatory closing conditions.

    The portfolio to be divested to Hasten includes cardiovascular…

    Takeda continues to execute on global strategy focused on life-transforming treatments for patients living with complex and rare diseases

    Fast tracks innovative medicines to patients in China in key business areas

    Takeda Pharmaceutical Company Limited ((TAK) ("Takeda") today announced that it has entered into an agreement to divest a portfolio of non-core prescription pharmaceutical products sold in China to Hasten Biopharmaceutic Co., Ltd. (China) ("Hasten"), a company funded by Feidong County of Hefei City, China and established by Ray Capital Management Limited ("Ray Capital")1 Takeda will receive $322 million USD, subject to customary legal and regulatory closing conditions.

    The portfolio to be divested to Hasten includes cardiovascular and metabolism products sold in mainland China. The portfolio generated FY2019 net sales of approximately $109.5 million USD, driven by strong sales of cardiovascular products such as Ebrantil®. While the products included in the sale continue to play important roles in meeting patient needs in the country, they are outside of Takeda's chosen business areas – Gastroenterology (GI), Rare Diseases, Plasma-Derived Therapies, Oncology and Neuroscience – that are core to its global long-term growth strategy.

    "China is an important market for Takeda in our efforts to accelerate the availability of our highly innovative medicines to patients living with complex and rare diseases," said Ricardo Marek, President, Growth & Emerging Markets Business Unit, Takeda. "This sale will further sharpen Takeda's focus and resources in fast tracking innovation in China, and the Emerging Markets. At the same time, we are confident that under Ray Capital, Hasten will be well-positioned to provide continued patient access to these trusted products in China."

    "This announcement marks continued progress on our commitment to simplify our global portfolio and remain focused on investing in our growth drivers, and research and development pipeline," said Costa Saroukos, Chief Financial Officer, Takeda. "We remain committed to expansion in China with more than 15 planned approvals over the next five years. By continuing to execute and deliver on Takeda's financial commitments, including paying down debt and focusing on our highly innovative portfolio, we can sustain our long-term growth and continue to deliver life-transforming treatments for patients worldwide."

    Takeda intends to use the proceeds from its divestitures to continue to reduce its debt and accelerate deleveraging toward its target of 2x net debt/adjusted EBITDA within FY2021 – FY2023.

    Takeda has sustained momentum in its divestiture strategy in 2020 and exceeded its $10 billion non-core asset divestiture target, announcing 10 deals since January 2019 to date for a total aggregate value of up to ~$11.3 billion, including agreements to divest:

    • Takeda Consumer Healthcare Company Limited to Oscar A-Co KK, a company controlled by funds managed by The Blackstone Group Inc. and its affiliates for a total value of approximately JPY 242.0 billion ($2.3 billion USD).
    • Other non-core portfolio assets within the Growth & Emerging Markets Business Unit, totaling up to approximately ~$2 billion with four separate buyers.2
    • Select OTC and non-core assets in Europe to Orifarm for up to approximately $670 million.
    • Non-core assets in Europe and Canada to Cheplapharm for approximately $562 million.
    • The TachoSil Fibrin Sealant Patch to Corza Health, Inc. for €350 million.

    Transactions still pending are expected to close by March 31, 2021, subject to customary legal and regulatory closing conditions.

    Transaction Details

    Takeda has entered into an agreement to sell a portfolio of five select non-core prescription pharmaceutical assets sold in mainland China to Hasten for $322 million USD.

    Under the terms of the agreement, Hasten will acquire the rights, title and interest to the products in the portfolio exclusive to China. Employees who are dedicated to the commercial support of these products today will be transferred to Hasten. Takeda and Hasten have also entered into a manufacturing and supply agreement under which Takeda will continue to manufacture the portfolio of divested products and supply them to Hasten.

    The agreement is expected to close by June 30, 2021, subject to the satisfaction of customary closing conditions, receipt of required regulatory clearances and, where applicable, satisfaction of local works council requirements. Until then, Takeda remains the owner of these products.

    Takeda is being advised by BofA Securities as its financial advisor and White & Case is its legal advisor in this transaction.

    About Takeda Pharmaceutical Company Limited

    Takeda Pharmaceutical Company Limited ((TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetic and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline.

    Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.

    For more information, visit https://www.takeda.com.

    Important Notice

    For the purposes of this notice, "press release" means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company

    Limited ("Takeda") regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

    The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, "Takeda" is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words "we", "us" and "our" are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

    Forward-Looking Statements

    This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as "targets", "plans", "believes", "hopes", "continues", "expects", "aims", "intends", "ensures", "will", "may", "should", "would", "could" "anticipates", "estimates", "projects" or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause 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; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or 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 countries in which Takeda operates, or on other facets of its 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/reports/sec-filings/ 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.

    1 Ray Capital is a biopharmaceutical investment company established by the Government of Hefei Municipality.

    2 Includes agreement with Hypera S.A. for the sale of select non-core products in Latin America which remains subject to close; and, completed sales of non-core assets in the Russia-CIS region to STADA, the Near East, Middle East and Africa region to Acino, and Asia Pacific to Celltrion Inc.

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  5. Updated ICLUSIG Label will Prove Practice-Changing, Expanding Indication to CP-CML Patients with Resistance or Intolerance to At Least Two Prior Tyrosine Kinase Inhibitors (TKIs) –

    ­– Approval Based on Data from the Phase 2 OPTIC Trial, Which Evaluated Response-Based ICLUSIG Dosing Regimens in CP-CML

    New Dosing Regimen in CP-CML Optimizes Benefit-Risk Profile, Providing Efficacy and Improving Safety

    Takeda Pharmaceutical Company Limited ((TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ICLUSIG® (ponatinib) for adult patients with chronic-phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors…

    Updated ICLUSIG Label will Prove Practice-Changing, Expanding Indication to CP-CML Patients with Resistance or Intolerance to At Least Two Prior Tyrosine Kinase Inhibitors (TKIs) –

    ­– Approval Based on Data from the Phase 2 OPTIC Trial, Which Evaluated Response-Based ICLUSIG Dosing Regimens in CP-CML

    New Dosing Regimen in CP-CML Optimizes Benefit-Risk Profile, Providing Efficacy and Improving Safety

    Takeda Pharmaceutical Company Limited ((TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ICLUSIG® (ponatinib) for adult patients with chronic-phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors. The updated label includes an optimized, response-based ICLUSIG dosing regimen in CP-CML with a daily starting dose of 45 mg and, upon achieving ≤1% BCR-ABL1IS, dose reduction to 15 mg. This dosing regimen aims to maximize benefit-risk by providing efficacy and decreasing the risk of adverse events (AEs), including arterial occlusive events (AOEs).

    "The FDA's approval of this sNDA is a major milestone for the CML community. Though chronic-phase CML is often manageable, many patients still experience poor long-term outcomes and could benefit from a third-generation TKI earlier in their treatment journey," said Teresa Bitetti, President, Global Oncology, Takeda. "ICLUSIG is proven to be effective for many patients with resistant disease, and its use at the critical moment can lead to meaningful outcomes for these patients. We are excited about this updated label and believe it will help address gaps in care for patients with resistant or intolerant chronic-phase CML by optimizing treatment with ICLUSIG."

    The sNDA approval is based on data from the Phase 2 OPTIC (Optimizing Ponatinib Treatment In CML) trial, as well as five-year data from the Phase 2 PACE (Ponatinib Ph+ ALL and CML Evaluation) trial.

    The OPTIC trial included patients with CP-CML whose disease was highly-resistant to their immediate prior TKI, the majority of whom (65%) did not achieve a response greater than complete hematological response (CHR) on immediate prior therapy. At 12 months, 42% of 88 patients utilizing the newly approved response-based dosing regimen (45 mg to 15 mg) achieved ≤1% BCR-ABL1IS, the primary endpoint of OPTIC, and at a median follow up time of 28.5 months, 73% of these patients maintained their response. In these patients, 13% experienced an AOE of any Grade, 7% experienced Grade 3 or higher. Risk factors such as uncontrolled hypertension or diabetes should be managed, and caution should be exercised when treating patients with active or substantial history of clinically significant, uncontrolled cardiovascular disease.

    "CML can be difficult to treat, particularly when patients have experienced resistance or intolerance to two or more TKIs. The revised indication allows physicians to consider ICLUSIG earlier in a course of treatment for chronic-phase CML patients, when it might provide the potential for the greatest benefit," said Jorge Cortes, MD, Director of the Georgia Cancer Center. "As evidenced by the updated label, response-based dosing of ICLUSIG may allow patients to achieve the desired benefit that we know ICLUSIG can provide while reducing the risk for arterial occlusive events, a concern of physicians and, therefore, an important aspect of chronic-phase CML management."

    Data from the OPTIC and PACE studies were presented virtually at the 56th American Society of Clinical Oncology (ASCO) Annual Meeting, the 25th European Hematology Association (EHA) Annual Meeting and the 62nd American Society of Hematology (ASH) Annual Meeting.

    About the OPTIC Trial

    OPTIC (Optimizing Ponatinib Treatment In CML) is an ongoing randomized, dose-ranging trial designed to evaluate three starting doses of ICLUSIG (15 mg, 30 mg, 45 mg) in patients with resistant chronic-phase (CP) chronic myeloid leukemia (CML) or who had documented history of presence of T315I mutation after receiving any number of prior TKIs. Dose reduction at response occurred per study protocol. The trial is expected to inform the optimal use of ICLUSIG® (ponatinib) in these patients. 282 patients were enrolled at clinical sites around the world, with 94 patients receiving the 45 mg starting dose. The primary endpoint of the trial is achieving ≤1% BCR-ABL1IS at 12 months.

    OPTIC data showed that optimal benefit-risk with ICLUSIG can be obtained with a response-based dosing regimen, 45 mg/day to 15 mg/day upon achieving ≤1% BCR-ABL1IS in patients with CP-CML highly resistant to prior TKI therapies both with or without BRC-ABL1 mutations. At 12 months, 42% of 88 patients who received the 45 mg starting dose achieved ≤1% BCR-ABL1IS. At a median follow up time of 28.5 months, the OPTIC study showed that, among patients receiving ICLUSIG 45 to 15 mg, 73% maintained their response. In these patients, 13% experienced an AOE of any Grade, 7% experienced Grade 3 or higher. Adverse reactions occurring in >20% of patients in the OPTIC trial included: rash and related conditions, hypertension, arthralgia, hyperlipidemia, hepatic dysfunction, pancreatitis, and abdominal pain. The most common (>20%) Grade 3 or 4 laboratory abnormalities were platelet count decreased and neutrophil cell count decreased.

    About the PACE Trial

    The PACE (Ponatinib Ph+ ALL and CML Evaluation) trial evaluated the efficacy and safety of ICLUSIG in CML and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) patients resistant or intolerant to dasatinib or nilotinib, or with the T315I mutation. A total of 449 patients were treated with ponatinib at a starting dose of 45 mg/day. An estimated 93% of patients previously received two or more approved TKIs and 56% of all patients had received three or more approved TKIs. 55% of 267 patients with CP-CML in the PACE trial achieved major cytogenetic response (MCyR) by 12 months – the primary endpoint of the PACE trial for CP-CML patients – and 70% of 64 CP-CML patients with T315I+ achieved MCyR. Enrollment in the PACE trial was completed in October 2011. In the PACE trial, 26% of 449 patients experienced AOEs. The most common (>20%) non-hematologic adverse reactions were rash and related conditions, arthralgia, abdominal pain, fatigue, constipation, headache, dry skin, fluid retention and edema, hepatic dysfunction, hypertension, pyrexia, nausea, hemorrhage, pancreatitis/lipase elevation, AOEs, diarrhea, vomiting, and myalgia.

    About CML and Ph+ ALL

    CML – a rare malignancy – is one of four main types of leukemia; it is a result of a genetic mutation that takes place in early, immature versions of myeloid cells, which form red blood cells, platelets and most types of white blood cells. Subsequently, an abnormal gene called BCR-ABL1 forms, turning the damaged cell into a CML cell. CML typically progresses slowly, but it can change into a fast-growing acute leukemia that is hard to treat.

    Ph+ ALL is a rare form of ALL that affects approximately 25% of adult ALL patients in the U.S. and is characterized by the presence of an abnormal gene, known as the Philadelphia chromosome. In patients who are Philadelphia chromosome-positive (Ph+), an abnormal chromosome is formed when pieces of chromosomes 9 and 22 switch with each other. This forms a longer chromosome 9 and a shorter chromosome 22, which leads to the development of BCR-ABL1 and is associated with Ph+ ALL.

    About ICLUSIG® (ponatinib) tablets

    ICLUSIG is a kinase inhibitor targeting BCR-ABL1, an abnormal tyrosine kinase that is expressed in CML and Ph+ ALL. ICLUSIG is a targeted cancer medicine developed using a computational and structure-based drug-design platform, specifically designed to inhibit the activity of BCR-ABL1 and its mutations. ICLUSIG inhibits native BCR-ABL1, as well as all BCR-ABL1 treatment-resistant mutations, including the most resistant T315I mutation. ICLUSIG is the only approved TKI that demonstrates activity against the T315I gatekeeper mutation of BCR-ABL1. This mutation has been associated with resistance to all other approved TKIs. ICLUSIG received full approval from the FDA in November 2016. ICLUSIG is indicated for the treatment of adult patients with chronic-phase (CP) CML with resistance or intolerance to at least two prior kinase inhibitors, accelerated-phase (AP) or blast-phase (BP) CML or Ph+ ALL for whom no other kinase inhibitor is indicated, and T315I-positive CML (CP, AP or BP) or T315I+ Ph+ ALL. ICLUSIG is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML.

    IMPORTANT SAFETY INFORMATION (U.S.)

    WARNING: ARTERIAL OCCLUSIVE EVENTS, VENOUS THROMBOEMBOLIC EVENTS, HEART FAILURE, and HEPATOTOXICITY

    See full prescribing information for complete boxed warning.

    • Arterial occlusive events (AOEs), including fatalities, have occurred in ICLUSIG-treated patients. AOEs included fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients age 50 years or younger, experienced these events. Monitor for evidence of AOEs. Interrupt or discontinue ICLUSIG based on severity. Consider benefit-risk to guide a decision to restart ICLUSIG.
    • Venous thromboembolic events (VTEs) have occurred in ICLUSIG-treated patients. Monitor for evidence of VTEs. Interrupt or discontinue ICLUSIG based on severity.
    • Heart failure, including fatalities, occurred in ICLUSIG-treated patients. Monitor for heart failure and manage patients as clinically indicated. Interrupt or discontinue ICLUSIG for new or worsening heart failure.
    • Hepatotoxicity, liver failure and death have occurred in ICLUSIG-treated patients. Monitor liver function tests. Interrupt or discontinue ICLUSIG based on severity.

     

    WARNINGS AND PRECAUTIONS

    Arterial Occlusive Events (AOEs): AOEs, including fatalities, have occurred in patients who received ICLUSIG in OPTIC and PACE. These included cardiovascular, cerebrovascular, and peripheral vascular events. The incidence of AOEs in OPTIC (45 mg -->15 mg) was 13% of 94 patients; 5% experienced Grade 3 or 4. In PACE, the incidence of AOEs was 26% of 449 patients; 14% experienced Grade 3 or 4. Fatal AOEs occurred in 2.1% of patients in OPTIC, and in 2% of patients in PACE. Some patients in PACE experienced recurrent or multisite vascular occlusion. Patients with and without cardiovascular risk factors, including patients age 50 years or younger, experienced these events. The most common risk factors observed with these events in PACE were history of hypertension, hypercholesterolemia, and non-ischemic cardiac disease. In OPTIC and PACE, AOEs were more frequent with increasing age.

    In OPTIC, patients with uncontrolled hypertension or diabetes and patients with clinically significant, uncontrolled, or active cardiovascular disease were excluded. In PACE, patients with uncontrolled hypertriglyceridemia and patients with clinically significant or active cardiovascular disease within the 3 months prior to the first dose of ICLUSIG were excluded. Consider whether the benefits of ICLUSIG are expected to exceed the risks.

    Monitor for evidence of AOEs. Interrupt, then resume at the same or decreased dose or discontinue ICLUSIG based on recurrence/severity. Consider benefit-risk to guide a decision to restart ICLUSIG.

    Venous Thromboembolic Events (VTEs): Serious or severe VTEs have occurred in patients who received ICLUSIG. In PACE, VTEs occurred in 6% of 449 patients including serious or severe (Grade 3 or 4) VTEs in 5.8% of patients. VTEs included deep venous thrombosis, pulmonary embolism, superficial thrombophlebitis, retinal vein occlusion, and retinal vein thrombosis with vision loss. The incidence was higher in patients with Ph+ ALL (9% of 32 patients) and BP-CML (10% of 62 patients). One of 94 patients in OPTIC experienced a VTE (Grade 1 retinal vein occlusion). Monitor for evidence of VTEs. Interrupt, then resume at the same or decreased dose or discontinue ICLUSIG based on recurrence/severity.

    Heart Failure: Fatal, serious or severe heart failure events have occurred in patients who received ICLUSIG. In PACE, heart failure occurred in 9% of 449 patients; 7% experienced serious or severe (Grade 3 or higher). Heart failure occurred in 12% of 94 patients in OPTIC; 1.1% experienced serious or severe (Grade 3 or 4). In PACE, the most frequently reported heart failure events (≥2%) were congestive cardiac failure (3.1%), decreased ejection fraction (2.9%), and cardiac failure (2%). In OPTIC, the most frequently reported heart failure events (>1 patient each) were left ventricular hypertrophy (2.1%) and BNP increased (2.1%). Monitor patients for signs or symptoms consistent with heart failure and manage heart failure as clinically indicated. Interrupt, then resume at reduced dose or discontinue ICLUSIG for new or worsening heart failure.

    Hepatotoxicity: ICLUSIG can cause hepatotoxicity, including liver failure and death. Fulminant hepatic failure leading to death occurred in 3 patients, with hepatic failure occurring within 1 week of starting ICLUSIG in one of these patients. These fatal cases occurred in patients with BP-CML or Ph+ ALL. Hepatotoxicity occurred in 25% of 94 patients in OPTIC and 32% of 449 patients in PACE. Grade 3 or 4 hepatotoxicity occurred in OPTIC (6% of 94 patients) and PACE (13% of 449 patients). The most frequent hepatotoxic events were elevations of ALT, AST, GGT, bilirubin, and alkaline phosphatase. Monitor liver function tests at baseline, then at least monthly or as clinically indicated. Interrupt, then resume at a reduced dose or discontinue ICLUSIG based on recurrence/severity.

    Hypertension: Serious or severe hypertension, including hypertensive crisis, has occurred in patients who received ICLUSIG. Patients may require urgent clinical intervention for hypertension associated with confusion, headache, chest pain, or shortness of breath. Monitor blood pressure at baseline and as clinically indicated and manage hypertension as clinically indicated. Interrupt, dose reduce, or stop ICLUSIG if hypertension is not medically controlled. For significant worsening, labile or treatment-resistant hypertension, interrupt ICLUSIG and consider evaluating for renal artery stenosis.

    Pancreatitis: Serious or severe pancreatitis has occurred in patients who received ICLUSIG. Elevations of lipase and amylase also occurred. In the majority of cases that led to dose modification or treatment discontinuation, pancreatitis resolved within 2 weeks. Monitor serum lipase every 2 weeks for the first 2 months and then monthly thereafter or as clinically indicated. Consider additional serum lipase monitoring in patients with a history of pancreatitis or alcohol abuse. Interrupt, then resume at the same or reduced dose or discontinue ICLUSIG based on severity. Evaluate for pancreatitis when lipase elevation is accompanied by abdominal symptoms.

    Increased Toxicity in Newly Diagnosed Chronic Phase CML: In a prospective randomized clinical trial in the first line treatment of newly diagnosed patients with CP-CML, single agent ICLUSIG 45 mg once daily increased the risk of serious adverse reactions 2-fold compared to single agent imatinib 400 mg once daily. The median exposure to treatment was less than 6 months. The trial was halted for safety. Arterial and venous thrombosis and occlusions occurred at least twice as frequently in the ICLUSIG arm compared to the imatinib arm. Compared to imatinib-treated patients, ICLUSIG-treated patients exhibited a greater incidence of myelosuppression, pancreatitis, hepatotoxicity, cardiac failure, hypertension, and skin and subcutaneous tissue disorders. ICLUSIG is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML.

    Neuropathy: Peripheral and cranial neuropathy occurred in patients in OPTIC and PACE. Some of these events in PACE were Grade 3 or 4. Monitor patients for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain or weakness. Interrupt, then resume at the same or reduced dose or discontinue ICLUSIG based on recurrence/severity.

    Ocular Toxicity: Serious or severe ocular toxicity leading to blindness or blurred vision have occurred in ICLUSIG-treated patients. The most frequent ocular toxicities occurring in OPTIC and PACE were dry eye, blurred vision, and eye pain. Retinal toxicities included age-related macular degeneration, macular edema, retinal vein occlusion, retinal hemorrhage, and vitreous floaters. Conduct comprehensive eye exams at baseline and periodically during treatment.

    Hemorrhage: Fatal and serious hemorrhage events have occurred in patients who received ICLUSIG. Fatal hemorrhages occurred in PACE and serious hemorrhages occurred in OPTIC and PACE. The incidence of serious bleeding events was higher in patients with AP-CML, BP-CML, and Ph+ ALL. Gastrointestinal hemorrhage and subdural hematoma were the most frequently reported serious hemorrhages. Events often occurred in patients with Grade 4 thrombocytopenia. Monitor for hemorrhage and manage patients as clinically indicated. Interrupt, then resume at the same or reduced dose or discontinue ICLUSIG based on recurrence/severity.

    Fluid Retention: Fatal and serious fluid retention events have occurred in patients who received ICLUSIG. In PACE, one instance of brain edema was fatal and serious events included pleural effusion, pericardial effusion, and angioedema. Monitor for fluid retention and manage patients as clinically indicated. Interrupt, then resume at the same or reduced dose or discontinue ICLUSIG based on recurrence/severity.

    Cardiac Arrhythmias: Cardiac arrhythmias, including ventricular and atrial arrhythmias, occurred in patients in OPTIC and PACE. For some patients, events were serious or severe (Grade 3 or 4) and led to hospitalization. Monitor for signs and symptoms suggestive of slow heart rate (fainting, dizziness) or rapid heart rate (chest pain, palpitations or dizziness) and manage patients as clinically indicated. Interrupt, then resume at the same or reduced dose or discontinue ICLUSIG based on recurrence/severity.

    Myelosuppression: Grade 3 or 4 events of neutropenia, thrombocytopenia, and anemia occurred in patients in OPTIC and PACE. The incidence of myelosuppression was greater in patients with AP-CML, BP-CML, and Ph+ ALL than in patients with CP-CML. Obtain complete blood counts every 2 weeks for the first 3 months and then monthly or as clinically indicated. If ANC less than 1 x 109/L or platelets less than 50 x 109/L, interrupt ICLUSIG until ANC at least 1.5 x 109/L and platelets at least 75 x 109/L, then resume at same or reduced dose.

    Tumor Lysis Syndrome (TLS): Serious TLS was reported in ICLUSIG-treated patients in OPTIC and PACE. Ensure adequate hydration and treat high uric acid levels prior to initiating ICLUSIG.

    Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS (also known as Posterior Reversible Encephalopathy Syndrome) has been reported in patients who received ICLUSIG. Along with neurological signs and symptoms, hypertension may be present. Diagnosis is made with supportive findings on magnetic resonance imaging (MRI) of the brain. Interrupt ICLUSIG until resolution. The safety of resumption of ICLUSIG in patients upon resolution of RPLS is unknown.

    Impaired Wound Healing and Gastrointestinal Perforation: Impaired wound healing occurred in patients receiving ICLUSIG. Withhold ICLUSIG for at least 1 week prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of ICLUSIG after resolution of wound healing complications has not been established. Gastrointestinal perforation or fistula occurred in patients receiving ICLUSIG. Permanently discontinue in patients with gastrointestinal perforation.

    Embryo-Fetal Toxicity: Based on its mechanism of action and findings from animal studies, ICLUSIG can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, adverse developmental effects occurred at exposures lower than human exposures at the recommended human dose. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with ICLUSIG and for 3 weeks after the last dose.

    ADVERSE REACTIONS

    The most common (>20%) adverse reactions are rash and related conditions, arthralgia, abdominal pain, headache, constipation, dry skin, hypertension, fatigue, fluid retention and edema, pyrexia, nausea, pancreatitis/lipase elevation, hemorrhage, anemia, hepatic dysfunction and AOEs. The most common Grade 3 or 4 laboratory abnormalities (>20%) are platelet count decreased, neutrophil cell count decreased, and white blood cell decreased.

    To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceutical Co. Ltd. at 1-844-817-6468 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    DRUG INTERACTIONS

    Strong CYP3A Inhibitors: Avoid coadministration or reduce ICLUSIG dose if coadministration cannot be avoided.

    Strong CYP3A Inducers: Avoid coadministration.

    USE IN SPECIFIC POPULATIONS

    Females and Males of Reproductive Potential: Verify pregnancy status of females of reproductive potential prior to initiating ICLUSIG.

    Ponatinib may impair fertility in females, and it is not known if these effects are reversible.

    Lactation: Advise women not to breastfeed during treatment with ICLUSIG and for 6 days following last dose.

    For more information about ICLUSIG, visit www.ICLUSIG.com. For the Prescribing Information including the Boxed Warning for arterial occlusion, venous thromboembolism, heart failure, and hepatoxicity, please visit https://www.iclusig.com/pdf/ICLUSIG-Prescribing-Information.pdf. For more information about ongoing research, please visit www.clinicaltrials.gov.

    Takeda's Commitment to Oncology

    Our core R&D mission is to deliver novel medicines to patients with cancer worldwide through our commitment to science, breakthrough innovation and passion for improving the lives of patients. Whether it's with our hematology therapies, our robust pipeline, or solid tumor medicines, we aim to stay both innovative and competitive to bring patients the treatments they need. For more information, visit www.takedaoncology.com.

    About Takeda Pharmaceutical Company Limited

    Takeda Pharmaceutical Company Limited ((TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetic and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries. For more information, visit https://www.takeda.com.

    Important Notice

    For the purposes of this notice, "press release" means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited ("Takeda") regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

    The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, "Takeda" is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words "we", "us" and "our" are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

    Forward-Looking Statements

    This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as "targets", "plans", "believes", "hopes", "continues", "expects", "aims", "intends", "ensures", "will", "may", "should", "would", "could" "anticipates", "estimates", "projects" or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause 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; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or 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 countries in which Takeda operates, or on other facets of its 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/reports/sec-filings/ 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.

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