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

16.55
-0.03  -0%
Previous Close 16.58
Open 16.66
52 Week Low 12.43
52 Week High 20.925
Market Cap $51,754,294,804
Shares 3,126,203,250
Float 3,126,203,250
Enterprise Value $94,779,109,215
Volume 1,066,808
Av. Daily Volume 1,123,766
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Upcoming Catalysts

Drug Stage Catalyst Date
Cabozantinib - COSMIC-311
Thyroid Carcinoma
Phase 3
Phase 3
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TAK-609
Hunter Syndrome
NDA Filing
NDA Filing
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Cabozantinib
Medullary Thyroid Cancer
Phase 3
Phase 3
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CB-839 + Cabozantinib (CANTATA)
Renal cell carcinoma
Phase 2
Phase 2
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Pevonedistat (TAK-924)
Higher-risk myelodysplastic syndromes (HR-MDS)
Phase 3
Phase 3
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CABOMETYX (cabozantinib) + atezolizumab (TECENTRIQ) - (COSMIC-312)
Hepatocellular Carcinoma
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
Cenicriviroc + Otezla (apremilast) + Firazyr (icatibant)
COVID-19 (severe)
Phase 2
Phase 2
Phase 2 trial initiation announced August 3, 2020.
CoVIg-19
COVID-19
Phase 1
Phase 1
Registration-enabling trial to commence in the coming weeks - noted July 31, 2020.
TAK-831
Negative symptoms of schizophrenia
Phase 2
Phase 2
Phase 2 trial is ongoing.
Ponatinib (OPTIC)
Chronic Myeloid Leukemia
Phase 2
Phase 2
Phase 2 data presented at EHA June 2020.
TAK-041
Anhedonia in depression
Phase 2
Phase 2
Phase 2 trial planned.
TAK-653
Treatment-resistant depression
Phase 2
Phase 2
Phase 2 trial planned.
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. New center in Omaha opens to support an urgent patient need for human plasma

    BioLife Plasma Services, part of the global biopharmaceutical company Takeda Pharmaceutical Company Limited, today announced the opening of a new plasma collection center in Omaha to collect standard plasma from healthy donors.

    "Now, more than ever, donors in the Omaha area have a unique opportunity to make a difference in the community through plasma donation, and we are deeply committed to making treatment options available for patients who rely on plasma-derived medications," said Jacy Cizek, manager of the BioLife Plasma Services Omaha center. "Plasma is a lifeline for thousands of people with rare, chronic and complex diseases, and we are excited to open the…

    New center in Omaha opens to support an urgent patient need for human plasma

    BioLife Plasma Services, part of the global biopharmaceutical company Takeda Pharmaceutical Company Limited, today announced the opening of a new plasma collection center in Omaha to collect standard plasma from healthy donors.

    "Now, more than ever, donors in the Omaha area have a unique opportunity to make a difference in the community through plasma donation, and we are deeply committed to making treatment options available for patients who rely on plasma-derived medications," said Jacy Cizek, manager of the BioLife Plasma Services Omaha center. "Plasma is a lifeline for thousands of people with rare, chronic and complex diseases, and we are excited to open the first BioLife plasma collection center in Nebraska."

    Through a simple, low-risk process called plasmapheresis, plasma is separated from the blood and the blood elements are returned back into the donor's body. Screened plasma collected from healthy individuals is processed into a wide variety of therapeutics for people around the world with rare, life-threatening diseases, such as immunodeficiency disorders, hemophilia and hereditary angioedema.

    Due to the COVID-19 pandemic, BioLife Plasma Services has implemented additional screening and safety measures in line with public health guidance to help guarantee the safety and health of donors and employees, as well as the safety of the collected plasma. All donors will need to wear a mask or other cloth face covering inside a BioLife Plasma center.

    Prospective donors can make online appointments to visit the Omaha center (275 N. 78th St., Omaha, NE 68114), which opens on Saturday, October 24. They must pass a physical examination at their first visit and are screened at each visit to ensure they meet eligibility criteria. All donors are compensated for their time and commitment.

    The Omaha center is approximately 11,330 square feet, and the state-of-the-art facility provides access to free Wi-Fi and a clean, professional, smoke-free environment. The new center is the first BioLife center to open in Nebraska and expects to bring more than 50 new jobs to the community.

    To learn more about BioLife Plasma Services, the donation process, and to schedule an appointment, please visit the BioLife website.

    About Plasma

    Plasma is the clear, straw-colored liquid portion of blood that can be easily replaced by the body. Plasma makes up more than half of whole blood and consists primarily of water and proteins. During plasma donation, a donor's blood is collected into an automated device that separates the plasma from the other whole blood components, including red and white blood cells and platelets. While the plasma is collected, the other blood components are returned to the donor. Each donation procedure uses sterile and disposable collection materials. The body quickly replaces the plasma removed during the donation process, which allows healthy individuals to donate as often as twice in a seven-day period, with at least one day between donations.

    About BioLife Plasma Services

    BioLife Plasma Services is an industry leader in the collection of high-quality plasma that is processed into life-saving plasma-based therapies. Founded in 2002, BioLife has been in operation for 18 years. We operate approximately 150 state-of-the-art plasma collection facilities across the United States and Europe. BioLife Plasma Services is part of Takeda Pharmaceutical Company Limited (NYSE:TAK), a global values-based, R&D-driven pharmaceutical company that produces and delivers plasma-derived therapies among other specialty medicines.

    About Takeda Pharmaceutical Company Limited

    Takeda Pharmaceutical Company Limited (NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, 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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  2. Collaboration will leverage cloud and data-driven insights to accelerate drug development, increase operational agility, reduce technology costs and develop the workforce of the future

    Takeda Pharmaceutical Company Limited ((TAK) ("Takeda"), Accenture (NYSE:ACN) and Amazon Web Services (AWS) have entered into a five-year strategic agreement to accelerate Takeda's digital transformation.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201013005154/en/

    Power of Three: Takeda Launches Cloud-Driven Business Transformation with Accenture and AWS (Photo: Business Wire)

    Power of Three: Takeda Launches Cloud-Driven Business Transformation with Accenture and AWS (Photo: Business Wire)

    Not only will patients benefit from Takeda's ability to respond with greater speed, agility, and insights across the value…

    Collaboration will leverage cloud and data-driven insights to accelerate drug development, increase operational agility, reduce technology costs and develop the workforce of the future

    Takeda Pharmaceutical Company Limited ((TAK) ("Takeda"), Accenture (NYSE:ACN) and Amazon Web Services (AWS) have entered into a five-year strategic agreement to accelerate Takeda's digital transformation.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201013005154/en/

    Power of Three: Takeda Launches Cloud-Driven Business Transformation with Accenture and AWS (Photo: Business Wire)

    Power of Three: Takeda Launches Cloud-Driven Business Transformation with Accenture and AWS (Photo: Business Wire)

    Not only will patients benefit from Takeda's ability to respond with greater speed, agility, and insights across the value chain, but customers, employees, and partners will also benefit. This long-term collaboration will fuel Takeda's cloud-driven business transformation by modernizing platforms, accelerating data services, establishing an internal engine for innovation, and equipping Takeda's employees with new skills and ways of working.

    "By combining the power of three organizations, Takeda is making a bold move to be at the intersection of human health, technology and business growth," said Christophe Weber, Takeda president and chief executive officer. "My vision is that, in less than ten years, every Takeda employee will be empowered by an artificial intelligence assistant to help make better decisions, enabling us to deliver transformative therapies and better experiences to patients, physicians and payers faster than previously possible. Together, Accenture and AWS will propel Takeda further than we could alone to make this vision a reality."

    Taking a cloud-first technology approach will create a more scalable, reliable and secure architecture and eliminate unnecessary integration activities. By moving 80% of applications to the cloud, Takeda will remove non-differentiating technology, reduce its internal data center footprint, and decrease capital expenditures.

    "By leveraging the most comprehensive set of cloud services in the industry, innovators like Takeda can cut costs, time to insight and discovery, and improve patient experiences," said Andy Jassy, chief executive officer of AWS. "The breadth and depth of AWS services enable Takeda to quickly and efficiently discover, develop, and manufacture therapeutics securely and compliantly. We're excited to continue our work with Takeda as they innovate to deliver accessible and promising new therapies to save lives."

    Accelerating the delivery of data services and capabilities will help Takeda increase connectivity and collaboration with the life sciences ecosystem and external partners. For example, the collaboration has already helped Takeda harness the cloud to launch, in less than five days, a secure data sharing and clinical trial acceleration platform for the COVID R&D Alliance. Without the cloud, launching the platform would have taken up to three months.

    In addition, the Plasma-Derived Therapies Business Unit, which develops critical, life-saving and life-sustaining therapies for patients with rare and complex diseases, is creating state-of-the-art, digitally-connected donation centers and modernizing the donor experience, optimizing the plasma collection process. Takeda's plans to increase its plasma collection and manufacturing capacity by at least 65% by 2024 are geared toward expanding access to essential medicines and accelerating new treatments for patients.

    "Takeda's bold move to become a cloud first company, 80% in the cloud, is a powerful example of how transformation benefits all – from accelerating therapies for patients, to empowering employees with new ways of working, creating new jobs, and upskilling people for the digital world, to the sustainability benefits of moving to the public cloud. We are proud to partner with Takeda and AWS to make this vision a reality at speed and scale," said Julie Sweet, chief executive officer, Accenture.

    Over the next three years, Takeda anticipates creating hundreds of new jobs in specialized roles in emerging data and digital fields, accessing new talent pools, and upskilling thousands of employees to propel its data and digital capabilities.

    About Takeda Pharmaceutical Company

    Takeda Pharmaceutical Company Limited ((TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, 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.

    About Accenture

    Accenture is a leading global professional services company, providing a broad range of services in strategy and consulting, interactive, technology and operations, with digital capabilities across all of these services. We combine unmatched experience and specialized capabilities across more than 40 industries — powered by the world's largest network of Advanced Technology and Intelligent Operations centers. With 506,000 people serving clients in more than 120 countries, Accenture brings continuous innovation to help clients improve their performance and create lasting value across their enterprises. Visit at www.accenture.com.

    Takeda 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.

    Copyright © 2020 Accenture. All rights reserved. Accenture, its logo, and High Performance Delivered are trademarks of Accenture.

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    • Interim analysis from VISIBLE OLE study showed long-term findings consistent with the known safety profile of vedolizumab with maintained rates of clinical remission and corticosteroid-free clinical remission
    • Entyvio® was the first maintenance biological therapy approved across Europe in both intravenous (IV) and subcutaneous (SC) formulations to treat moderately to severely active ulcerative colitis or Crohn's disease
    • Latest data presented at the United European Gastroenterology Week (UEG Week) Virtual 2020 congress

    Takeda Pharmaceutical Company Limited (NYSE:TAK) ("Takeda") today announced interim results from the VISIBLE open-label extension (OLE) study on the long-term safety and efficacy of maintenance treatment with the subcutaneous…

    • Interim analysis from VISIBLE OLE study showed long-term findings consistent with the known safety profile of vedolizumab with maintained rates of clinical remission and corticosteroid-free clinical remission
    • Entyvio® was the first maintenance biological therapy approved across Europe in both intravenous (IV) and subcutaneous (SC) formulations to treat moderately to severely active ulcerative colitis or Crohn's disease
    • Latest data presented at the United European Gastroenterology Week (UEG Week) Virtual 2020 congress

    Takeda Pharmaceutical Company Limited (NYSE:TAK) ("Takeda") today announced interim results from the VISIBLE open-label extension (OLE) study on the long-term safety and efficacy of maintenance treatment with the subcutaneous (SC) formulation of the gut-selective biologic Entyvio® (vedolizumab) in patients with moderately to severely active ulcerative colitis (UC). In evaluating the primary safety endpoint of the trial, interim data of the UC patient population showed that following two years of maintenance therapy with vedolizumab SC, long-term safety findings were consistent with the known safety profile of vedolizumab.1 Patients also continued to demonstrate clinical benefit from treatment, through maintenance of clinical remission* and corticosteroid-free clinical remission** rates, the clinical efficacy outcomes of the trial.1 These data were announced in an oral presentation at the UEG Week Virtual 2020 congress.

    VISIBLE OLE is an ongoing open-label, phase 3b, multinational, multicenter study to evaluate the long-term safety and tolerability of vedolizumab SC in adult patients with ulcerative colitis or Crohn's disease (CD), following enrolment and participation in the VISIBLE 1 (UC) or VISIBLE 2 (CD) studies.1,2 Participants who completed the maintenance period up to week 52 (randomized completers), or who achieved clinical response at week 14 after a third vedolizumab IV infusion at week 6 (non-randomized week 14 responders), received vedolizumab SC 108 mg every two weeks.1,2 Interim data from the VISIBLE OLE study in the UC patient population demonstrated that adverse events were consistent with the known safety profile of vedolizumab.1 During two years of maintenance treatment, adverse events occurred in 69% of patients with UC, with disease exacerbations (18%), nasopharyngitis (11%), upper respiratory tract infection (9%), and anemia (7%) reported most frequently.1 Injection site reactions were reported in 4.5% of patients and all were mild or moderate in severity.1 Serious adverse events occurred in 14% of patients, with no cases of progressive multifocal leukoencephalopathy and no deaths.1

    In randomized completers, rates of clinical remission and corticosteroid-free clinical remission were maintained up to week 108 (week 6: 71.0% [n=49/69] and week 108: 68.9% [n=42/61], respectively; week 52: 78.3% [n=18/23] to week 108: 70.0% [n=14/20], respectively).1 In non-randomized week 14 responders, the comparative rates were 62.6% [n=67/107] at week 14 and 33.3% [n=31/93] at week 110 for clinical remission, and 24.5% [n=12/49] at week 54 and 25.0% [n=11/44] at week 110 for corticosteroid-free clinical remission.1

    "These latest safety and effectiveness data for vedolizumab SC provide additional support/data that the benefits received from subcutaneous vedolizumab are sustained during long-term maintenance therapy," said Asit Parikh, MD PhD, Head of Takeda's Gastroenterology Therapeutic Area Unit. "Entyvio® SC was approved by the European Commission in May 2020, offering greater choice on mode of administration in line with the diverse medical needs and preferences of patients, plus the option of home-administration outside of the medical setting. Takeda's commitment to gastrointestinal innovation continues and we are working to develop a needle-free jet injector application that would broaden choice for patients even further."

    * Clinical remission is defined as a partial Mayo score of ≤2 with no individual subscore >1 point1

    ** Corticosteroid-free clinical remission is defined as patients using oral corticosteroids at baseline (week 0) who have discontinued oral corticosteroids and are in clinical remission1

    ###

    About the VISIBLE Clinical Trial Program

    The VISIBLE clinical trial program aims to assess the efficacy and safety of a subcutaneous (SC) formulation of vedolizumab as maintenance therapy in adult patients with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD).

    The VISIBLE program consists of three phase 3 studies involving over 1,000 UC and CD patients which includes two randomized, double-blind, placebo-controlled studies examining the proportion of patients achieving clinical remission at week 52, and an open-label extension study to determine the long-term safety and efficacy of vedolizumab SC.2,3,4

    About Ulcerative Colitis and Crohn's Disease

    Ulcerative colitis (UC) and Crohn's disease (CD) are two of the most common forms of inflammatory bowel disease (IBD).5 Both UC and CD are chronic, relapsing, remitting, inflammatory conditions of the gastrointestinal tract, with CD potentially progressing over time.6,7 UC only involves the large intestine as opposed to CD which can affect any part of the GI tract from mouth to anus.8,9 CD can also affect the entire thickness of the bowel wall while UC only involves the innermost lining of the large intestine.8,9 UC commonly presents with symptoms of abdominal discomfort, loose bowel movements, including blood or pus.8,10 CD commonly presents with symptoms of abdominal pain, diarrhea, and weight loss.6 The cause of UC or CD is not fully understood; however, recent research suggests hereditary, genetics, environmental factors, and/or an abnormal immune response to microbial antigens in genetically predisposed individuals can lead to UC or CD.8,11,12

    About Entyvio® (vedolizumab)

    Vedolizumab is a gut-selective biologic and is approved in both intravenous (IV) and subcutaneous (SC) formulations.13,14 The SC formulation is currently approved in Europe, Canada and Australia only. It is a humanized monoclonal antibody designed to specifically antagonize the alpha4beta7 integrin, inhibiting the binding of alpha4beta7 integrin to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1), but not vascular cell adhesion molecule 1 (VCAM-1).15 MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract.16 The alpha4beta7 integrin is expressed on a subset of circulating white blood cells.15 These cells have been shown to play a role in mediating the inflammatory process in ulcerative colitis (UC) and Crohn's disease (CD).15,17,18 By inhibiting alpha4beta7 integrin, vedolizumab may limit the ability of certain white blood cells to infiltrate gut tissues.15

    Vedolizumab is approved for the treatment of adult patients with moderately to severely active UC and CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα)-antagonist.13,14 Vedolizumab has been granted marketing authorization in over 70 countries, including the United States and European Union, with more than 510,000 patient years of exposure to date.19

    Therapeutic Indications for vedolizumab

    Ulcerative colitis

    Vedolizumab is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist.

    Crohn's disease

    Vedolizumab is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist.

    Important Safety Information for vedolizumab

    Contraindications

    Hypersensitivity to the active substance or to any of the excipients.

    Special warnings and special precautions for use

    Intravenous vedolizumab should be administered by a healthcare professional prepared to manage hypersensitivity reactions, including anaphylaxis, if they occur. Appropriate monitoring and medical support measures should be available for immediate use when administering intravenous vedolizumab. Observe patients during infusion and until the infusion is complete.

    Infusion-related reactions and Hypersensitivity Reactions

    In clinical studies, infusion-related reactions (IRR) and hypersensitivity reactions have been reported, with the majority being mild to moderate in severity. If a severe IRR, anaphylactic reaction, or other severe reaction occurs, administration of vedolizumab must be discontinued immediately and appropriate treatment initiated (e.g., epinephrine and antihistamines). If a mild to moderate IRR occurs, the infusion rate can be slowed or interrupted and appropriate treatment initiated (e.g., epinephrine and antihistamines). Once the mild or moderate IRR subsides, continue the infusion. Physicians should consider pre-treatment (e.g., with antihistamine, hydrocortisone and/or paracetamol) prior to the next infusion for patients with a history of mild to moderate IRR to vedolizumab, in order to minimize their risks.

    Infections

    Vedolizumab is a gut-selective integrin antagonist with no identified systemic immunosuppressive activity. Physicians should be aware of the potential increased risk of opportunistic infections or infections for which the gut is a defensive barrier. Vedolizumab treatment is not to be initiated in patients with active, severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections until the infections are controlled, and physicians should consider withholding treatment in patients who develop a severe infection while on chronic treatment with vedolizumab. Caution should be exercised when considering the use of vedolizumab in patients with a controlled chronic severe infection or a history of recurring severe infections. Patients should be monitored closely for infections before, during and after treatment. Before starting treatment with vedolizumab, screening for tuberculosis may be considered according to local practice. Some integrin antagonists and some systemic immunosuppressive agents have been associated with progressive multifocal leukoencephalopathy (PML), which is a rare and often fatal opportunistic infection caused by the John Cunningham (JC) virus. By binding to the α4β7 integrin expressed on gut-homing lymphocytes, vedolizumab exerts an immunosuppressive effect specific to the gut. No systemic immunosuppressive effect was noted in healthy subjects. Healthcare professionals should monitor patients on vedolizumab for any new onset or worsening of neurological signs and symptoms, and consider neurological referral if they occur. If PML is suspected, treatment with vedolizumab must be withheld; if confirmed, treatment must be permanently discontinued. Typical signs and symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body, clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. The progression of deficits usually leads to death or severe disability over weeks or months.

    Malignancies

    The risk of malignancy is increased in patients with ulcerative colitis and Crohn's disease. Immunomodulatory medicinal products may increase the risk of malignancy.

    Prior and concurrent use of biological products

    No vedolizumab clinical trial data are available for patients previously treated with natalizumab. No clinical trial data for concomitant use of vedolizumab with biologic immunosuppressants are available. Therefore, the use of vedolizumab in such patients is not recommended.

    Vaccinations

    Prior to initiating treatment with vedolizumab all patients should be brought up to date with all recommended immunizations. Patients receiving vedolizumab may receive non-live vaccines (e.g., subunit or inactivated vaccines) and may receive live vaccines only if the benefits outweigh the risks.

    Adverse reactions include: nasopharyngitis, headache, arthralgia, upper respiratory tract infection, bronchitis, influenza, sinusitis, cough, oropharyngeal pain, nausea, rash, pruritus, back pain, pain in extremities, pyrexia, fatigue, injection site reactions and anaphylaxis.

    Injection Site Reactions (subcutaneous vedolizumab)

    No clinically relevant differences in the overall safety profile and adverse events were observed in patients who received subcutaneous vedolizumab compared to the safety profile observed in clinical studies with intravenous vedolizumab with the exception of injection site reactions (with subcutaneous administration only). Injection-site reactions were mild or moderate in intensity, and none were reported as serious.

    Please consult with your local regulatory agency for approved labeling in your country.

    For EU audiences, please see the Summary of Product Characteristics (SmPC) for ENTYVIO®.

    For U.S. audiences, please see the full Prescribing Information, including Medication Guide for ENTYVIO® IV.

    Takeda in Gastroenterology

    We believe that GI and liver diseases are not just life disrupting conditions, but diseases that can impact a patient's quality of life.20,21 Beyond a fundamental need for effective treatment options, we understand that improving patients' lives also depends on their needs being recognized. With nearly 30 years of experience in gastroenterology, Takeda has made significant strides in addressing GI patient needs with treatments for inflammatory bowel disease (IBD), acid-related diseases, short bowel syndrome (SBS), and motility disorders. We are making significant strides toward closing the gap on new areas of unmet needs for patients who have celiac disease, eosinophilic esophagitis, alpha-1 antitrypsin-associated liver disease, Crohn's disease, and acute pancreatitis, among others. Together with researchers, patient groups and more, we are working to advance scientific research and clinical medicine in GI.

    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 bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, 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.

    ###

    References

    1 Vermeire S, Danese S, Krisztina, et al. Long-term treatment with vedolizumab SC in ulcerative colitis: interim results from VISIBLE OLE. Presented at UEG Week 2020. Oral presentation OP090.

    2 Vedolizumab Subcutaneous Long-Term Open-Label Extension Study. Available at: https://clinicaltrials.gov/ct2/show/NCT02620046 Last updated: March 13, 2020. Last accessed: October 2020.

    3 Efficacy and safety of vedolizumab subcutaneously (SC) as maintenance therapy in ulcerative colitis. Available at: https://clinicaltrials.gov/ct2/show/NCT02611830. Last updated: January 23, 2020. Last accessed: October 2020.

    4 Efficacy and safety of vedolizumab subcutaneous (SC) as maintenance therapy in Crohn's disease. Available at: https://clinicaltrials.gov/ct2/show/NCT02611817. Last updated: June 23, 2020. Last accessed: October 2020.

    5 Baumgart DC, Carding SR. Inflammatory bowel disease: cause and immunobiology. Lancet. 2007;369:1627-1640.

    6 Baumgart DC, Sandborn WJ. Crohn's disease. Lancet. 2012;380:1590-1605.

    7 Torres J, Billioud V, Sachar DB, et al. Ulcerative colitis as a progressive disease: the forgotten evidence. Inflamm Bowel Dis. 2012;18:1356-1363.

    8 Ordas I, Eckmann L, Talamini M, et al. Ulcerative colitis. Lancet. 2012;380:1606-1619.

    9 Feuerstein JD, Cheifetz AS. Crohn's disease: Epidemiology, diagnosis and management. Mayo Clin Proc. 2017;92:1088-1103.

    10 Sands BE. From symptom to diagnosis: clinical distinctions among various forms of intestinal inflammation. Gastroenterology. 2004;126:1518-1532.

    11 Henckaerts L, Pierik M, Joossens M, et al. Mutations in pattern recognition receptor genes modulate seroreactivity to microbial antigens in patients with inflammatory bowel disease. Gut. 2007;56:1536-1542.

    12 Kaser A, Zeissig S, Blumberg RS. Genes and environment: How will our concepts on the pathophysiology of IBD develop in the future? Dig Dis. 2010;28:395-405.

    13 Entyvio Prescribing Information. Available at: https://general.takedapharm.com/ENTYVIOPI. Last updated: March 2020. Last accessed: October 2020.

    14 Entyvio EPAR _ 20/02/2019 Entyvio - EMEA/H/C/002782_ European Medicines Agency - Entyvio _ Annex I Summary of product characteristics. Committee For Medicinal Products For Human Use. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/entyvio. Last updated: May 2020. Last accessed: October 2020.

    15 Soler D, Chapman T, Yang LL, et al. The binding specificity and selective antagonism of vedolizumab, an anti-α4β7 integrin therapeutic antibody in development for inflammatory bowel diseases. J Pharmacol Exp Ther. 2009;330:864-875.

    16 Briskin M, Winsor-Hines D, Shyjan A, et al. Human mucosal addressin cell adhesion molecule-1 is preferentially expressed in intestinal tract and associated lymphoid tissue. Am J Pathol. 1997;151:97‑110.

    17 Eksteen B, Liaskou E, Adams DH. Lymphocyte homing and its roles in the pathogenesis of IBD. Inflamm Bowel Dis. 2008;14:1298‑1312.

    18 Wyant T, Fedyk E, Abhyankar B. An overview of the mechanism of action of the monoclonal antibody vedolizumab. J Crohns Colitis. 2016;10:1437-1444.

    19 Takeda Data on File. 2019.

    20 Center for Drug Evaluation and Research (CDER) & the FDA. The Voice of the patient/functional gastrointestinal disorder. 2016. Available at: https://www.fda.gov/media/95140/download. Last accessed: October 2020.

    21 Jones R, Hunt C, Stevens R, et al. Management of common gastrointestinal disorders: quality criteria based on patients' views and practice guidelines. Br J Gen Pract. 2009;59:e199-208.

    Copyright 2020 Takeda Pharmaceutical Company Limited. All rights reserved. Takeda and the Takeda Logo are registered trademarks of Takeda Pharmaceutical Company Limited.

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  3. −        Potential first-in-class therapy designed to treat the underlying cause of liver disease associated with AATD

    −        Arrowhead is eligible to receive up to $1.04B including an upfront payment of $300M and potential development, regulatory and commercial milestones up to $740M

    −        Investigational medicine ARO-AAT to be co-developed and co-commercialized in the United States by Takeda and Arrowhead under a 50/50 profit-sharing structure

    −        Takeda receives exclusive license to commercialize ARO-AAT outside the U.S.

    −        Arrowhead will hold a conference call and webcast today, Oct. 8, at 8:30 a.m. ET

    Takeda Pharmaceutical Company Limited ((TAK) ("Takeda") and Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR) today announced…

    −        Potential first-in-class therapy designed to treat the underlying cause of liver disease associated with AATD

    −        Arrowhead is eligible to receive up to $1.04B including an upfront payment of $300M and potential development, regulatory and commercial milestones up to $740M

    −        Investigational medicine ARO-AAT to be co-developed and co-commercialized in the United States by Takeda and Arrowhead under a 50/50 profit-sharing structure

    −        Takeda receives exclusive license to commercialize ARO-AAT outside the U.S.

    −        Arrowhead will hold a conference call and webcast today, Oct. 8, at 8:30 a.m. ET

    Takeda Pharmaceutical Company Limited ((TAK) ("Takeda") and Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR) today announced a collaboration and licensing agreement to develop ARO-AAT, a Phase 2 investigational RNA interference (RNAi) therapy in development to treat alpha-1 antitrypsin-associated liver disease (AATLD). ARO-AAT is a potential first-in-class therapy designed to reduce the production of mutant alpha-1 antitrypsin protein, the cause of AATLD progression.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201008005340/en/

    Under the terms of the agreement, Takeda and Arrowhead will co-develop ARO-AAT which, if approved, will be co-commercialized in the United States under a 50/50 profit-sharing structure. Outside the U.S., Takeda will lead the global commercialization strategy and receive an exclusive license to commercialize ARO-AAT with Arrowhead eligible to receive tiered royalties of 20-25% on net sales. Arrowhead will receive an upfront payment of $300 million and is eligible to receive potential development, regulatory and commercial milestones up to $740 million. Closing of the transaction is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S.

    "AAT-associated liver disease is a devastating condition for which there are no approved therapies. With its RNAi-based mechanism of action, ARO-AAT has the potential to treat the underlying cause of AATLD, thereby helping patients avoid the need for liver transplantation and associated co-morbidities," said Asit Parikh, M.D., Ph.D., Head, Gastroenterology Therapeutic Area Unit at Takeda. "We are excited to collaborate with Arrowhead to bring forward this exciting late-stage liver asset for the Alpha-1 community as part of our growing GI portfolio."

    "Takeda's global presence and experience with payers and regulators in the rare disease and GI therapy space, combined with its long history serving the Alpha-1 community make it the ideal partner for ARO-AAT. It is well-positioned to work with the patient and medical community to help meet the severe unmet need of patients with Alpha-1 liver disease," said Christopher Anzalone, Ph.D., President and CEO at Arrowhead. "This agreement also supports our strategy of using partnering selectively to continue to invest in our Targeted RNAi Molecule (TRiMTM) platform and the growing pipeline of RNAi therapeutics targeting diverse tissue types, while focusing our commercial organization on opportunities in two key areas of cardiometabolic and pulmonary."

    About Alpha-1 Antitrypsin-Associated Liver Disease

    Alpha-1 Antitrypsin-Associated Deficiency (AATD) is a rare genetic disorder associated with liver disease in children and adults and pulmonary disease in adults. AATD is estimated to affect 1 per 3,000-5,000 people in the United States and 1 per 2,500 in Europe. The protein AAT is primarily synthesized and secreted by liver hepatocytes. Its function is to inhibit enzymes that can break down normal connective tissue. The most common disease variant, the Z mutant, has a single amino acid substitution that results in improper folding of the protein. The mutant protein cannot be effectively secreted and accumulates in globules inside the hepatocytes. This triggers continuous hepatocyte injury, leading to fibrosis, cirrhosis, and increased risk of hepatocellular carcinoma.

    Individuals with the homozygous PiZZ genotype have severe deficiency of functional AAT leading to pulmonary disease and liver disease. Lung disease is frequently treated with AAT augmentation therapy. However, augmentation therapy does nothing to treat liver disease, and there is no specific therapy for hepatic manifestations. There is a significant unmet need as liver transplant, with its attendant morbidity and mortality, is currently the only available cure.

    About ARO-AAT

    ARO-AAT is designed to knock down the hepatic production of the mutant alpha-1 antitrypsin (Z-AAT) protein, the cause of progressive liver disease in AATD patients. Reducing production of the inflammatory Z-AAT protein is expected to halt the progression of liver disease and potentially allow it to regenerate and repair.

    Takeda in Gastroenterology

    We believe that GI and liver diseases are not just life disrupting conditions, but diseases that can impact a patient's quality of life.1,2 Beyond a fundamental need for effective treatment options, we understand that improving patients' lives also depends on their needs being recognized. With nearly 30 years of experience in gastroenterology, Takeda has made significant strides in addressing GI patient needs with treatments for inflammatory bowel disease (IBD), acid-related diseases, short bowel syndrome (SBS), and motility disorders. We are making significant strides toward closing the gap on new areas of unmet needs for patients who have celiac disease, eosinophilic esophagitis, alpha-1 antitrypsin-associated liver disease, Crohn's disease, and acute pancreatitis, among others. Together with researchers, patient groups and more, we are working to advance scientific research and clinical medicine in GI.

    Arrowhead Conference Call and Webcast Information

    Investors may access a live audio webcast on the Company's website at http://ir.arrowheadpharma.com/events.cfm. For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 1790033.

    A replay of the webcast will be available on the company's website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 1790033.

    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 bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, 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.

    Takeda 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.

    About Arrowhead Pharmaceuticals

    Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. For more information, please visit www.arrowheadpharma.com, or follow us on Twitter @ArrowheadPharma. To be added to the Company's email list and receive news directly, please visit http://ir.arrowheadpharma.com/email-alerts.

    Arrowhead Safe Harbor Statement under the Private Securities Litigation Reform Act:

    This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including the safety and efficacy of our product candidates, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, our ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets and the enforcement of our intellectual property rights. Our most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q discuss some of the important risk factors that may affect our business, results of operations and financial condition. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.

    References:


    1 Center for Drug Evaluation and Research (CDER) & the FDA. The Voice of the Patient/Functional Gastrointestinal Disorder; 2016. https://www.fda.gov/media/95140/download

    2 Jones R, et al. Management of common gastrointestinal disorders: quality criteria based on patients' views and practice guidelines. Br J Gen Pract. 2009; 59(563):e199-208.

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  4. Companion diagnostics will be developed to identify patients with NSCLC that harbor ALK fusions and EGFR Exon20 insertion mutations to match patients with appropriate targeted therapies from Takeda

    Foundation Medicine, Inc. and Takeda Pharmaceuticals USA, Inc., a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited (NYSE:TAK), today announced a collaboration for the development of Foundation Medicine's tissue- and blood-based companion diagnostics for use with marketed and investigational treatments in Takeda's late-stage lung cancer portfolio. If approved, the appropriate companion diagnostics would be used to identify patients who may be eligible for mobocertinib, an investigational drug being evaluated for the treatment of patients…

    Companion diagnostics will be developed to identify patients with NSCLC that harbor ALK fusions and EGFR Exon20 insertion mutations to match patients with appropriate targeted therapies from Takeda

    Foundation Medicine, Inc. and Takeda Pharmaceuticals USA, Inc., a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited (NYSE:TAK), today announced a collaboration for the development of Foundation Medicine's tissue- and blood-based companion diagnostics for use with marketed and investigational treatments in Takeda's late-stage lung cancer portfolio. If approved, the appropriate companion diagnostics would be used to identify patients who may be eligible for mobocertinib, an investigational drug being evaluated for the treatment of patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ metastatic non-small cell lung cancer (mNSCLC), and ALUNBRIG® (brigatinib), Takeda's tyrosine kinase inhibitor (TKI) recently FDA-approved to treat patients with TKI-naïve anaplastic lymphoma kinase-positive (ALK+) mNSCLC.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200918005250/en/

    NSCLC is the most common form of lung cancer, accounting for approximately 85 percent of the estimated 1.8 million new patients diagnosed each year worldwide;1 ,2 and forty percent of patients with NSCLC are diagnosed with metastatic disease.3 EGFR Exon20 insertion mutations occur in approximately 1-2 percent of patients with mNSCLC and these patients have no FDA-approved treatment options designed to target these Exon20 alterations.4, 5 ALK+ mNSCLC is a complex and aggressive form of lung cancer found in approximately 3-5 percent of patients with mNSCLC.6,7,8

    "Our collaboration with Foundation Medicine will address an urgent need for broad access to genomic tests, ultimately expanding treatment options and potentially improving outcomes for people with ALK+ and EGFR Exon20 insertion+ mNSCLC," said Christopher Arendt, Head, Oncology Therapeutic Area Unit, Takeda. "Robust, accurate and timely testing is crucial to enable oncologists to make informed treatment decisions so that advanced cancer patients receive the optimal therapy for their disease."

    Foundation Medicine's proven portfolio of FDA-approved comprehensive genomic profiling tests offer physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions. As companion diagnostics, FoundationOne®CDx and FoundationOne®Liquid CDx allow oncologists to identify patients who may be appropriate for FDA-approved targeted therapies. Through this collaboration, FoundationOne CDx and FoundationOne Liquid CDx will be developed for use with Takeda's therapies.

    "We're proud to partner with Takeda on this important journey to allow more lung cancer patients to have access to genomic testing to inform personalized treatment decisions," said Cindy Perettie, Chief Executive Officer at Foundation Medicine. "Takeda shares our patient-centric approach to research and development and mission to advance personalized cancer care. This collaboration leveraging our portfolio of FDA-approved genomic tests will accelerate our shared vision and make precision medicine a reality for more patients."

    About FoundationOne Liquid CDx

    FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test for prescription use only that uses targeted high throughput hybridization-based capture technology to analyze 324 genes utilizing circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of advanced cancer patients. The test is FDA-approved to report short variants in 311 genes, including rearrangements and copy number losses in BRCA1 and BRCA2, and is a companion diagnostic to identify patients who may benefit from treatment with specific targeted therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if available. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.

    About FoundationOne CDx

    FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit http://www.F1CDxLabel.com.

    About Mobocertinib (TAK-788)

    Mobocertinib is a potent, small-molecule TKI specifically designed to selectively target epidermal growth factor receptor (EGFR) and human EGFR2 (HER2) Exon 20 insertion mutations. In 2019, the U.S. FDA granted mobocertinib Orphan Drug Designation for the treatment of lung cancer with HER2 mutations or EGFR mutations including Exon20 insertion+ metastatic non-small cell lung cancer (mNSCLC). In April 2020, mobocertinib received Breakthrough Therapy Designation from the FDA for patients with EGFR Exon20 insertion+ mNSCLC whose disease has progressed on or after platinum-based chemotherapy. The mobocertinib development program began in the NSCLC population and is expected to expand to additional underserved populations in other tumor types. Mobocertinib is an investigational drug for which efficacy and safety have not been established.

    About ALUNBRIG® (brigatinib)

    ALUNBRIG is a potent and selective next-generation tyrosine kinase inhibitor (TKI) that was designed to target anaplastic lymphoma kinase (ALK) molecular alterations.

    ALUNBRIG is approved in the U.S. and European Union (EU) as a first-line treatment for patients with ALK-positive (ALK+) metastatic non-small cell lung cancer (mNSCLC) previously not treated with an ALK inhibitor. ALUNBRIG is also approved in more than 40 countries, including the U.S., Canada and the EU, for the treatment of people living with ALK+ mNSCLC who have taken the medicine crizotinib, but their NSCLC has worsened or they cannot tolerate taking crizotinib.

    About Foundation Medicine

    Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient's cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine's molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

    Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.

    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 bringing Better Health and a Brighter Future to patients by translating science into highly innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, 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.

    ALUNBRIG IMPORTANT SAFETY INFORMATION

    WARNINGS AND PRECAUTIONS

    Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, and fatal pulmonary adverse reactions consistent with interstitial lung disease (ILD)/pneumonitis have occurred with ALUNBRIG. In the ALUNBRIG arm of trial ALTA 1L (180 mg once daily), ILD/pneumonitis occurred in 5.1% of patients receiving ALUNBRIG. ILD/pneumonitis occurred within 8 days of initiation of ALUNBRIG in 2.9% of patients, with Grade 3 to 4 reactions occurring in 2.2% of patients. In Trial ALTA, ILD/pneumonitis occurred in 3.7% of patients in the 90 mg group (90 mg once daily) and 9.1% of patients in the 90→180 mg group (180 mg once daily with 7-day lead-in at 90 mg once daily). Adverse reactions consistent with possible ILD/pneumonitis occurred early within 9 days of initiation of ALUNBRIG (median onset was 2 days) in 6.4% of patients, with Grade 3 to 4 reactions occurring in 2.7%. Monitor for new or worsening respiratory symptoms (e.g., dyspnea, cough, etc.), particularly during the first week of initiating ALUNBRIG. Withhold ALUNBRIG in any patient with new or worsening respiratory symptoms, and promptly evaluate for ILD/pneumonitis or other causes of respiratory symptoms (e.g., pulmonary embolism, tumor progression, and infectious pneumonia). For Grade 1 or 2 ILD/pneumonitis, either resume ALUNBRIG with dose reduction after recovery to baseline or permanently discontinue ALUNBRIG. Permanently discontinue ALUNBRIG for Grade 3 or 4 ILD/pneumonitis or recurrence of Grade 1 or 2 ILD/pneumonitis.

    Hypertension: In the ALUNBRIG arm of trial ALTA 1L (180 mg once daily), hypertension was reported in 32% of patients receiving ALUNBRIG; Grade 3 hypertension occurred in 13% of patients. In ALTA, hypertension was reported in 11% of patients in the 90 mg group who received ALUNBRIG and 21% of patients in the 90→180 mg group. Grade 3 hypertension occurred in 5.9% of patients overall. Control blood pressure prior to treatment with ALUNBRIG. Monitor blood pressure after 2 weeks and at least monthly thereafter during treatment with ALUNBRIG. Withhold ALUNBRIG for Grade 3 hypertension despite optimal antihypertensive therapy. Upon resolution or improvement to Grade 1, resume ALUNBRIG at the same dose. Consider permanent discontinuation of treatment with ALUNBRIG for Grade 4 hypertension or recurrence of Grade 3 hypertension. Use caution when administering ALUNBRIG in combination with antihypertensive agents that cause bradycardia.

    Bradycardia: In the ALUNBRIG arm of trial ALTA 1L (180 mg once daily), heart rates less than 50 beats per minute (bpm) occurred in 8.1% of patients receiving ALUNBRIG. Grade 3 bradycardia occurred in 1 patient (0.7%). In ALTA, heart rates less than 50 beats per minute (bpm) occurred in 5.7% of patients in the 90 mg group and 7.6% of patients in the 90→180 mg group. Grade 2 bradycardia occurred in 1 (0.9%) patient in the 90 mg group. Monitor heart rate and blood pressure during treatment with ALUNBRIG. Monitor patients more frequently if concomitant use of drug known to cause bradycardia cannot be avoided. For symptomatic bradycardia, withhold ALUNBRIG and review concomitant medications for those known to cause bradycardia. If a concomitant medication known to cause bradycardia is identified and discontinued or dose adjusted, resume ALUNBRIG at the same dose following resolution of symptomatic bradycardia; otherwise, reduce the dose of ALUNBRIG following resolution of symptomatic bradycardia. Discontinue ALUNBRIG for life-threatening bradycardia if no contributing concomitant medication is identified.

    Visual Disturbance: In the ALUNBRIG arm of trial ALTA 1L (180 mg once daily), Grade 1 or 2 adverse reactions leading to visual disturbance including blurred vision, photophobia, photopsia, and reduced visual acuity were reported in 7.4% of patients receiving ALUNBRIG. In ALTA, adverse reactions leading to visual disturbance including blurred vision, diplopia, and reduced visual acuity, were reported in 7.3% of patients treated with ALUNBRIG in the 90 mg group and 10% of patients in the 90→180 mg group. Grade 3 macular edema and cataract occurred in one patient each in the 90→180 mg group. Advise patients to report any visual symptoms. Withhold ALUNBRIG and obtain an ophthalmologic evaluation in patients with new or worsening visual symptoms of Grade 2 or greater severity. Upon recovery of Grade 2 or Grade 3 visual disturbances to Grade 1 severity or baseline, resume ALUNBRIG at a reduced dose. Permanently discontinue treatment with ALUNBRIG for Grade 4 visual disturbances.

    Creatine Phosphokinase (CPK) Elevation: In the ALUNBRIG arm of trial ALTA 1L (180 mg once daily), creatine phosphokinase (CPK) elevation occurred in 81% of patients who received ALUNBRIG. The incidence of Grade 3 or 4 CPK elevation was 24%. Dose reduction for CPK elevation occurred in 15% of patients. In ALTA, CPK elevation occurred in 27% of patients receiving ALUNBRIG in the 90 mg group and 48% of patients in the 90 mg→180 mg group. The incidence of Grade 3‑4 CPK elevation was 2.8% in the 90 mg group and 12% in the 90→180 mg group. Dose reduction for CPK elevation occurred in 1.8% of patients in the 90 mg group and 4.5% in the 90→180 mg group. Advise patients to report any unexplained muscle pain, tenderness, or weakness. Monitor CPK levels during ALUNBRIG treatment. Withhold ALUNBRIG for Grade 3 or 4 CPK elevation with Grade 2 or higher muscle pain or weakness. Upon resolution or recovery to Grade 1 CPK elevation or baseline, resume ALUNBRIG at the same dose or at a reduced dose.

    Pancreatic Enzyme Elevation: In the ALUNBRIG arm of trial ALTA 1L (180 mg once daily), amylase elevation occurred in 52% of patients and Grade 3 or 4 amylase elevation occurred in 6.8% of patients. Lipase elevations occurred in 59% of patients and Grade 3 or 4 lipase elevation occurred in 17% of patients. In ALTA, amylase elevation occurred in 27% of patients in the 90 mg group and 39% of patients in the 90→180 mg group. Lipase elevations occurred in 21% of patients in the 90 mg group and 45% of patients in the 90→180 mg group. Grade 3 or 4 amylase elevation occurred in 3.7% of patients in the 90 mg group and 2.7% of patients in the 90→180 mg group. Grade 3 or 4 lipase elevation occurred in 4.6% of patients in the 90 mg group and 5.5% of patients in the 90→180 mg group. Monitor lipase and amylase during treatment with ALUNBRIG. Withhold ALUNBRIG for Grade 3 or 4 pancreatic enzyme elevation. Upon resolution or recovery to Grade 1 or baseline, resume ALUNBRIG at the same dose or at a reduced dose.

    Hyperglycemia: In the ALUNBRIG arm of trial ALTA 1L (180 mg once daily), 56% of patients who received ALUNBRIG experienced new or worsening hyperglycemia. Grade 3 hyperglycemia, based on laboratory assessment of serum fasting glucose levels, occurred in 7.5% of patients. In ALTA, 43% of patients who received ALUNBRIG experienced new or worsening hyperglycemia. Grade 3 hyperglycemia, based on laboratory assessment of serum fasting glucose levels, occurred in 3.7% of patients. Two of 20 (10%) patients with diabetes or glucose intolerance at baseline required initiation of insulin while receiving ALUNBRIG. Assess fasting serum glucose prior to initiation of ALUNBRIG and monitor periodically thereafter. Initiate or optimize anti-hyperglycemic medications as needed. If adequate hyperglycemic control cannot be achieved with optimal medical management, withhold ALUNBRIG until adequate hyperglycemic control is achieved and consider reducing the dose of ALUNBRIG or permanently discontinuing ALUNBRIG.

    Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, ALUNBRIG can cause fetal harm when administered to pregnant women. There are no clinical data on the use of ALUNBRIG in pregnant women. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with ALUNBRIG and for at least 4 months following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for at least 3 months after the last dose of ALUNBRIG.

    ADVERSE REACTIONS

    In ALTA 1L, serious adverse reactions occurred in 33% of patients receiving ALUNBRIG. The most common serious adverse reactions other than disease progression were pneumonia (4.4%), ILD/pneumonitis (3.7%), pyrexia (2.9%), dyspnea (2.2%), pulmonary embolism (2.2%), and asthenia (2.2%). Fatal adverse reactions other than disease progression occurred in 2.9% of patients and included pneumonia (1.5%), cerebrovascular accident (0.7%), and multiple organ dysfunction syndrome (0.7%).

    In ALTA, serious adverse reactions occurred in 38% of patients in the 90 mg group and 40% of patients in the 90→180 mg group. The most common serious adverse reactions were pneumonia (5.5% overall, 3.7% in the 90 mg group, and 7.3% in the 90→180 mg group) and ILD/pneumonitis (4.6% overall, 1.8% in the 90 mg group and 7.3% in the 90→180 mg group). Fatal adverse reactions occurred in 3.7% of patients and consisted of pneumonia (2 patients), sudden death, dyspnea, respiratory failure, pulmonary embolism, bacterial meningitis and urosepsis (1 patient each).

    The most common adverse reactions (≥25%) with ALUNBRIG were diarrhea (49%), fatigue (39%), nausea (39%), rash (38%), cough (37%), myalgia (34%), headache (31%), hypertension (31%), vomiting (27%), and dyspnea (26%).

    DRUG INTERACTIONS

    CYP3A Inhibitors: Avoid coadministration of ALUNBRIG with strong or moderate CYP3A inhibitors. Avoid grapefruit or grapefruit juice as it may also increase plasma concentrations of brigatinib. If coadministration of a strong or moderate CYP3A inhibitor cannot be avoided, reduce the dose of ALUNBRIG.

    CYP3A Inducers: Avoid coadministration of ALUNBRIG with strong or moderate CYP3A inducers. If coadministration of moderate CYP3A inducers cannot be avoided, increase the dose of ALUNBRIG.

    CYP3A Substrates: Coadministration of ALUNBRIG with sensitive CYP3A substrates, including hormonal contraceptives, can result in decreased concentrations and loss of efficacy of sensitive CYP3A substrates.

    USE IN SPECIFIC POPULATIONS

    Pregnancy: ALUNBRIG can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus.

    Lactation: There are no data regarding the secretion of brigatinib in human milk or its effects on the breastfed infant or milk production. Because of the potential adverse reactions in breastfed infants, advise lactating women not to breastfeed during treatment with ALUNBRIG.

    Females and Males of Reproductive Potential:

    Pregnancy Testing: Verify pregnancy status in females of reproductive potential prior to initiating ALUNBRIG.

    Contraception: Advise females of reproductive potential to use effective non-hormonal contraception during treatment with ALUNBRIG and for at least 4 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with ALUNBRIG and for at least 3 months after the final dose.

    Infertility: ALUNBRIG may cause reduced fertility in males.

    Pediatric Use: The safety and effectiveness of ALUNBRIG in pediatric patients have not been established.

    Geriatric Use: Of the 359 patients enrolled in the ALTA 1L ALUNBRIG arm and in ALTA, 26.7% were 65 and older and 7.5% were 75 and older. No clinically relevant differences in safety or efficacy were observed between patients ≥65 years and younger patients.

    Hepatic or Renal Impairment: No dose adjustment is recommended for patients with mild or moderate hepatic impairment or mild or moderate renal impairment. Reduce the dose of ALUNBRIG for patients with severe hepatic impairment or severe renal impairment.

    Please see the full U.S. Prescribing Information for ALUNBRIG at www.ALUNBRIG.com.

    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.

    Source: Foundation Medicine

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