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

17.25
+0.2  (+1%)
Previous Close 17.05
Open 17.08
52 Week Low 15.303
52 Week High 20
Market Cap $54,385,382,826
Shares 3,152,775,816
Float 3,152,775,816
Enterprise Value $90,500,249,079
Volume 1,928,250
Av. Daily Volume 3,462,372
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Upcoming Catalysts

Drug Stage Catalyst Date
TAK-721
Eosinophilic esophagitis
PDUFA priority review
PDUFA priority review
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
CoVIg-19
COVID-19
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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CABOMETYX (cabozantinib) + atezolizumab (TECENTRIQ) - (COSMIC-312)
Hepatocellular Carcinoma
Phase 3
Phase 3
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Cabozantinib - COSMIC-311
Thyroid Carcinoma
sNDA Filing
sNDA Filing
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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-935/OV935
Dravet Syndrome / Lennox-Gastaut Syndrome
Phase 3
Phase 3
Phase 3 trials to commence 2Q 2021.
TAK-831 / NBI-1065844
Negative symptoms of schizophrenia
Phase 2
Phase 2
Phase 2 trial did not meet primary endpoint - March 2, 2021.
ALUNBRIG versus alectinib ALTA 3
ALK+ Advanced NSCLC
Phase 3
Phase 3
Phase 3 trial is enrolling.
TAK-620 (maribavir)
Cytomegalovirus (CMV)
Phase 3
Phase 3
Phase 3 trial met primary endpoint - December 4, 2020.
Mobocertinib (TAK-788)
Non-Small Cell Lung Cancer
Phase 1/2
Phase 1/2
Phase 1/2 data presented at IASLC 2020 World Conference on Lung Cancer January 29, 2021.
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.
Ponatinib
Chronic Myeloid Leukemia
Approved
Approved
FDA approval announced December 18, 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.
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. Takeda Pharmaceutical Company Limited ((TAK) ("Takeda") today announced that it will host a conference call on April 6, 2021 to provide updates on select New Molecular Entities (NMEs) in its Wave 1 pipeline portfolio. With several NME regulatory filings expected by year-end FY2021, the company will outline plans for organic and sustainable revenue growth over the next several years.

    Date
    April 6, 2021

    Time
    8:00 a.m. – 10:30 a.m. ET / 9:00 p.m. – 11:30 p.m. JT

    Agenda
    The agenda for Takeda's call is as follows:

    TIME (ET)

    TIME (JT)

    Session/Speaker

    8:00 a.m. – 8:05 a.m.

    9:00 p.m. – 9:05 p.m.

    Introduction
    Christophe Weber, president and CEO

    8:05 a.m. – 8:10 a.m.

    9:05 p.m. – 9:10 p.m.

    Delivering an Innovative Pipeline…

    Takeda Pharmaceutical Company Limited ((TAK) ("Takeda") today announced that it will host a conference call on April 6, 2021 to provide updates on select New Molecular Entities (NMEs) in its Wave 1 pipeline portfolio. With several NME regulatory filings expected by year-end FY2021, the company will outline plans for organic and sustainable revenue growth over the next several years.

    Date

    April 6, 2021

    Time

    8:00 a.m. – 10:30 a.m. ET / 9:00 p.m. – 11:30 p.m. JT

    Agenda

    The agenda for Takeda's call is as follows:

    TIME (ET)

    TIME (JT)

    Session/Speaker

    8:00 a.m. – 8:05 a.m.

    9:00 p.m. – 9:05 p.m.

    Introduction

    Christophe Weber, president and CEO

    8:05 a.m. – 8:10 a.m.

    9:05 p.m. – 9:10 p.m.

    Delivering an Innovative Pipeline to Our Patients: Spotlight on Select Wave 1 Programs

    Andy Plump, president of Research and Development

    8:10 a.m. – 8:35 a.m.

    9:10 p.m. – 9:35 p.m.

    Maribavir (TAK-620): Potential Game Changer in the Treatment for Post-Transplant Cytomegalovirus (CMV) Infection

    Obi Umeh, global program lead, Rare Genetic and Hematology Therapeutic Area Unit

    Claus Jepsen, head of Global Product and Launch Strategy, Rare Genetic and Hematology Therapeutic Area Unit 

    8:35 a.m. – 8:40a.m.

    9:35 p.m. – 9:40p.m.

    Break

    8:40 a.m. – 9:00 a.m.

    9:40 p.m. – 10:00 p.m.

    Soticlestat (TAK-935): Novel MoA for Treatment of Dravet Syndrome and Lennox-Gastaut Syndrome

    Sarah Sheikh, head of Neuroscience Therapeutic Area Unit 

    Erika Gill, head of Global Product and Launch Strategy, Neuroscience Therapeutic Area 

    9:00 a.m. – 9:35 a.m.

    10:00 p.m. – 10:35 p.m.

    Orexin Franchise Strategy Update: First Potential Medicine to Treat the Underlying Disease in Patients with Narcolepsy Type 1

    Elena Koundourakis, head of Orexin Franchise Development, Neuroscience Therapeutic Area 

    Erika Gill, head of Global Product and Launch Strategy, Neuroscience Therapeutic Area 

    9:35 a.m. – 9:40 a.m.

    10:35 p.m. – 10:40 p.m.

    Delivering an Innovative Pipeline to Our Patients: Spotlight on Select Wave 1 Programs

    Ramona Sequeira, president of U.S. Business Unit & Global Portfolio Commercialization 

    9:40 a.m. – 10:30 a.m.

    10:40 p.m. – 11:30 p.m.

    Panel Q&A Session

    To access the live webcast, including presentation slides, visit our web site at www.takeda.com/investors/ir-events. An archived copy of the presentation slides will be available following the conclusion of the event.

    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, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and 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/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.

    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.

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  2. Takeda Pharmaceutical Company Limited ((TAK) ("Takeda") today announced the completion of its previously-announced sale of a portfolio of select products to Orifarm Group ("Orifarm") for a total value of up to $670 million USD. The portfolio includes approximately 130 over-the-counter (OTC) and prescription pharmaceutical products sold in Europe, and two manufacturing sites located in Denmark and Poland. This divestment agreement was first announced in April 2020.

    The divested portfolio includes OTC products and food supplements, plus select products within the Cardiovascular, Anti-inflammatory, Respiratory, and Endocrinology therapeutic areas, primarily sold in Denmark, Norway, Belgium, Poland, Finland, Sweden, the Baltics and Austria. The…

    Takeda Pharmaceutical Company Limited ((TAK) ("Takeda") today announced the completion of its previously-announced sale of a portfolio of select products to Orifarm Group ("Orifarm") for a total value of up to $670 million USD. The portfolio includes approximately 130 over-the-counter (OTC) and prescription pharmaceutical products sold in Europe, and two manufacturing sites located in Denmark and Poland. This divestment agreement was first announced in April 2020.

    The divested portfolio includes OTC products and food supplements, plus select products within the Cardiovascular, Anti-inflammatory, Respiratory, and Endocrinology therapeutic areas, primarily sold in Denmark, Norway, Belgium, Poland, Finland, Sweden, the Baltics and Austria. The portfolio generated FY2020 net sales of approximately $240 million USD, driven by sales of cough/cold and vitamin OTC brands, along with prescription products such as Warfarub and Levaxin, and other strong regional brands. The products, while addressing key patient needs in these countries, are outside of the business areas Takeda has chosen as core to its global long-term growth.

    As previously announced, Takeda and Orifarm have also entered into manufacturing and supply agreements under which Takeda will continue to manufacture select products on behalf of Orifarm. In addition, approximately 600 employees from the manufacturing sites, sales and marketing professionals and others supporting the divested portfolio and manufacturing sites have transitioned to Orifarm.

    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 exceeded its $10 billion non-core asset divestiture target and has announced 12 deals since January 2019 to date for a total aggregate value of up to approximately $12.9 billion.

    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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  3. Takeda Pharmaceutical Company Limited (TYO:4502) (NYSE:TAK) ("Takeda") today announced the completion of its previously-announced sale of Takeda Consumer Healthcare Company Limited ("TCHC") to Oscar A-Co KK, a company controlled by funds managed by The Blackstone Group Inc. and its affiliates (collectively "Blackstone") for a total value of JPY 242.0 billion1. This divestment agreement was first announced in August 2020.

    Following the transfer of shares, TCHC will be excluded from the scope of consolidation of Takeda2, and operates as Alinamin Pharmaceutical Co., Ltd ("Alinamin Pharmaceuticals").

    The divested portfolio included a variety of over-the-counter ("OTC") medicines and health products that generated total revenues of over JPY 60.0…

    Takeda Pharmaceutical Company Limited (TYO:4502) (NYSE:TAK) ("Takeda") today announced the completion of its previously-announced sale of Takeda Consumer Healthcare Company Limited ("TCHC") to Oscar A-Co KK, a company controlled by funds managed by The Blackstone Group Inc. and its affiliates (collectively "Blackstone") for a total value of JPY 242.0 billion1. This divestment agreement was first announced in August 2020.

    Following the transfer of shares, TCHC will be excluded from the scope of consolidation of Takeda2, and operates as Alinamin Pharmaceutical Co., Ltd ("Alinamin Pharmaceuticals").

    The divested portfolio included a variety of over-the-counter ("OTC") medicines and health products that generated total revenues of over JPY 60.0 billion in fiscal year 2019. TCHC's strong regional brands included Alinamin, its top selling product and Japan's first vitamin B1 preparation, and Benza, a cold remedy. Takeda is confident that under Blackstone, Alinamin Pharmaceuticals will be well-positioned to continue growing and developing its product offerings in the years to come to address the evolving needs of consumers.

    Takeda 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 FY2021 – FY2023.

    Takeda has sustained momentum in its divestiture strategy and has exceeded its $10 billion non-core asset divestiture target. Takeda has announced 12 deals since January 2019, for a total aggregate value of up to approximately $12.9 billion.

    The sales price is currently anticipated to be approximately JPY 230.0 billion, subject to certain adjustments, including net debt and working capital of TCHC and Takeda Healthcare Products Company Limited as of March 31, 2021. With the completion of the transfer of shares, a pre-tax gain of approximately JPY 140.0 billion on the sale of shares of a subsidiary will be recognized, and Takeda anticipates Reported Net Profit attributable to owners of the Company to increase by approximately the same amount in the fiscal year ending March 31, 2021 (FY2020). Since the gain on the sale of shares of the subsidiary relates to the divestiture of a non-core business, there will be no impact on Core Operating Profit or Core Net Profit.

    1 Enterprise value. Actual sales price will be determined after adjustment for items including net debt and working capital of TCHC and Takeda Healthcare Products Company Limited ("THP").

    2 As a result of the share transfer, a wholly owned subsidiary of TCHC, THP, will also be excluded from the scope of consolidation of Takeda.

    About Takeda Pharmaceutical Company Limited

    Takeda Pharmaceutical Company Limited (TYO:4502) (NYSE: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, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and 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/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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  4. European Medicines Agency to Conduct First-Ever Parallel Assessment of a Medicinal Product, Takeda's Dengue Vaccine Candidate (TAK-003), for use in the EU; Countries Outside of the EU through the EU-M4all (Previously Article 58) Procedure

    Takeda Intends to Submit Regulatory Filings in Argentina, Brazil, Colombia, Indonesia, Malaysia, Mexico, Singapore, Sri Lanka and Thailand During 2021

    TAK-003 is Being Studied for the Prevention of Dengue Due to any Dengue Virus Serotype in Individuals Ages Four to 60

    Takeda Pharmaceutical Company Limited ((TAK) ("Takeda") today announced that the European Medicines Agency (EMA) has accepted the Company's filing packages for its dengue vaccine candidate (TAK-003) which is being investigated for the…

    European Medicines Agency to Conduct First-Ever Parallel Assessment of a Medicinal Product, Takeda's Dengue Vaccine Candidate (TAK-003), for use in the EU; Countries Outside of the EU through the EU-M4all (Previously Article 58) Procedure

    Takeda Intends to Submit Regulatory Filings in Argentina, Brazil, Colombia, Indonesia, Malaysia, Mexico, Singapore, Sri Lanka and Thailand During 2021

    TAK-003 is Being Studied for the Prevention of Dengue Due to any Dengue Virus Serotype in Individuals Ages Four to 60

    Takeda Pharmaceutical Company Limited ((TAK) ("Takeda") today announced that the European Medicines Agency (EMA) has accepted the Company's filing packages for its dengue vaccine candidate (TAK-003) which is being investigated for the prevention of dengue due to any dengue virus serotype in individuals ages four to 60. Takeda intends to submit regulatory filings in Argentina, Brazil, Colombia, Indonesia, Malaysia, Mexico, Singapore, Sri Lanka and Thailand during 2021.

    "Submission of regulatory filings for our dengue vaccine candidate, TAK-003, marks an important development for people who are living in or traveling to communities burdened by the threat of dengue," said Derek Wallace, VP, Dengue Global Program Leader at Takeda. "Dengue outbreaks, which result in half a million hospitalizations globally each year, can overwhelm communities and governments because of the broad impact on the health care system. With limited options to prevent the disease, there is a pressing need for widely available dengue vaccines. Takeda is committed to working with regulatory authorities and recommending bodies to support evaluation of our submissions and achieve access for TAK-003."

    Takeda is participating in the EMA's first-ever parallel assessment of a medicinal product for use in the European Union (EU), and through the EU-M4all (previously Article 58) procedure for countries outside of the EU. Along with the scientific opinion issued by the Committee for Medicinal Products for Human Use (CHMP), national regulators in countries participating in the EU-M4all procedure will conduct their own assessments to determine if national marketing authorizations for TAK-003 are granted. Takeda is also seeking approval of TAK-003 in dengue-endemic countries that are not participating in the EU-M4all procedure.

    Regulatory submissions for TAK-003 include long-term safety and efficacy data through 36 months from the ongoing pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial. Takeda intends to present and publish details of the 36-month data at a scientific meeting and in a peer-reviewed journal this year.

    Takeda also intends to submit regulatory filings in the United States, followed by additional countries in Asia and Latin America.

    EU-M4all1

    EU-M4all (or EU-Medicines for all) is a procedure designed to facilitate patient access to essential medicines or vaccines intended to prevent or treat diseases of major public health interest. Through the EU-M4all procedure (previously known as the Article 58 procedure), the EMA, in cooperation with the World Health Organization (WHO), can provide scientific opinion on medicines and vaccines for public health priority diseases that are intended for markets outside of the EU.

    About TAK-003

    Takeda's tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus, which provides the genetic "backbone" for all four vaccine viruses.2 Clinical Phase 2 data in children and adolescents showed that TAK-003 induced immune responses against all four dengue serotypes, in both seropositive and seronegative participants, which persisted through 48 months after vaccination, and the vaccine was found to be generally safe and well tolerated.3 The pivotal Phase 3 TIDES trial met its primary endpoint of overall vaccine efficacy (VE) against virologically confirmed dengue (VCD) at 12 months follow-up and all secondary endpoints at 18 months follow-up for which there were a sufficient number of dengue cases, including VE against hospitalized dengue and VE in baseline seropositive and baseline seronegative individuals.4,5 Efficacy varied by serotype. The results demonstrated TAK-003 was generally well tolerated, and there have been no important safety risks observed to date.

    About the Phase 3 TIDES (DEN-301) Trial

    The double-blind, randomized, placebo-controlled Phase 3 TIDES trial is 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.4 The TIDES trial is Takeda's largest interventional clinical trial to date and enrolled over 20,000 healthy children and adolescents ages four to 16 years living in dengue-endemic areas. Study participants were randomly assigned to receive either TAK-003 0.5 mL or placebo by subcutaneous injection on Day 1 and Day 90.4 The study is comprised of five parts. Part 1 and the primary endpoint analysis evaluated vaccine efficacy (VE) and safety through 15 months after the first dose (12 months after the second dose).4 Part 2 continued for an additional six months to complete the assessment of the secondary endpoints of VE by serotype, baseline serostatus and disease severity, including VE against hospitalized dengue.4 Part 3 is evaluating VE and long-term safety by following participants for an additional two and a half to three years.6 Part 4 will evaluate safety for 13 months following booster vaccination and Part 5 will evaluate long-term safety for one year after completion of Part 4.6

    The trial is taking place at sites in dengue-endemic areas in Latin America (Brazil, Colombia, Panama, the Dominican Republic and Nicaragua) and Asia (Philippines, Thailand and Sri Lanka) where there are unmet needs in dengue prevention and where severe dengue is a leading cause of serious illness and death among children.4 Baseline blood samples were collected from all individuals participating in the trial to allow for evaluation of safety and efficacy based on serostatus. Takeda and an independent Data Monitoring Committee of experts are actively monitoring safety on an ongoing basis.

    About Dengue

    Dengue is the fastest spreading mosquito-borne viral disease and was one of the WHO's top 10 threats to global health in 2019.7,8 Dengue is mainly spread by Aedes aegypti mosquitoes and, to a lesser extent, Aedes albopictus mosquitoes. It is caused by any of four dengue virus serotypes, each of which can cause dengue fever or severe dengue. The prevalence of individual serotypes varies across different geographies, countries, regions, seasons and over time.9 Recovery from infection by one serotype provides lifelong immunity against only that serotype, and later exposure to any of the remaining serotypes is associated with an increased risk of severe disease.

    Dengue is pandemic prone, and outbreaks are observed in tropical and sub-tropical areas and have recently caused outbreaks in parts of the continental United States and Europe.10,11 Approximately half of the world now lives under the threat of dengue, which is estimated to cause 390 million infections and around 20,000 deaths globally each year.10,12 The dengue virus can infect people of all ages and is a leading cause of serious illness among children in some countries in Latin America and Asia.10

    Takeda's Commitment to Vaccines

    Vaccines prevent 2 to 3 million deaths each year and have transformed global public health.13 For the past 70 years, Takeda has supplied vaccines to protect the health of people in Japan. Today, Takeda's global vaccine business is applying innovation to tackle some of the world's most challenging infectious diseases, such as dengue, COVID-19, Zika and norovirus. Takeda's team brings an outstanding track record and a wealth of knowledge in vaccine development, manufacturing and global access to advance a pipeline of vaccines to address some of the world's most pressing public health needs. For more information, visit www.TakedaVaccines.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, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and 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.

    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.

    ###


    1The European Medicines Agency. Medicines for use outside the EU — EU-M4all. July 2020. Retrieved March 2021.

    2 Huang CY-H, et al. Genetic and phenotypic characterization of manufacturing seeds for tetravalent dengue vaccine (DENVax). PLoS Negl Trop Dis. 2013;7:e2243.

    3Tricou, V, Sáez-Llorens X, et al. Safety and immunogenicity of a tetravalent dengue vaccine in children aged 2-17 years: a randomised, placebo-controlled, phase 2 trial. Lancet. 2020. doi:10.1016/S0140-6736(20)30556-0.

    4 Biswal S, et al. Efficacy of a tetravalent dengue vaccine in healthy children and adolescents. N Engl J Med. 2019; 2019;381:2009-2019.

    5 Biswal S, et al. Efficacy of a tetravalent dengue vaccine in healthy children aged 4-16 years: a randomized, placebo controlled, phase 3 trial. Lancet. 2020. 2020;395:1423-1433.

    6 ClinicalTrials.Gov. Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children (TIDES). Retrieved March 2021.

    7 World Health Organization. Factsheet. Dengue and Severe Dengue. April 2019. Retrieved February 2021.

    8 World Health Organization. Ten threats to global health in 2019. 2019. Retrieved February 2021.

    9 Guzman MG, et al. Dengue: a continuing global threat. Nature Reviews Microbiology. 2010;8:S7-S16.

    10 Knowlton K, et al. Mosquito-Borne Dengue Fever Threat Spreading in the Americas. The Natural Resources Defense Council (NRDC). 2009. Retrieved February 2021.

    11 Chan E, et al. Using web search query data to monitor dengue epidemics: a new model for neglected tropical disease surveillance. PLoS Negl Trop Dis. 2011;5:e1206.

    12 Centers for Disease Control and Prevention. About Dengue: What You Need to Know. May 2019. Retrieved February 2021.

    13 UNICEF. Vaccination and Immunization Statistics. 2019. Retrieved February 2021.

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    • EVOTEC LEVERAGES ITS PROPRIETARY SMALL MOLECULE RNA TARGETING PLATFORM AGAINST MULTIPLE RNA TARGETS ACROSS TAKEDA'S KEY INDICATIONS
    • EVOTEC RECEIVES RESEARCH FUNDING AND IS ELIGIBLE FOR SUCCESS-BASED MILESTONES AND TIERED ROYALTIES

    HAMBURG, GERMANY / ACCESSWIRE / March 22, 2021 / Evotec SE ((Frankfurt Stock Exchange: EVT, MDAX/TecDAX, OTC:EVOTF) today announced that the Company has entered into a multi-RNA target alliance with Takeda Pharmaceutical Company Limited ("Takeda") with the goal to discover and develop RNA targeting small molecule therapeutics for highly attractive targets that are difficult to address via more conventional approaches.

    Evotec and Takeda will jointly identify and develop small molecules targeting a range of RNA targets…

    • EVOTEC LEVERAGES ITS PROPRIETARY SMALL MOLECULE RNA TARGETING PLATFORM AGAINST MULTIPLE RNA TARGETS ACROSS TAKEDA'S KEY INDICATIONS
    • EVOTEC RECEIVES RESEARCH FUNDING AND IS ELIGIBLE FOR SUCCESS-BASED MILESTONES AND TIERED ROYALTIES

    HAMBURG, GERMANY / ACCESSWIRE / March 22, 2021 / Evotec SE ((Frankfurt Stock Exchange: EVT, MDAX/TecDAX, OTC:EVOTF) today announced that the Company has entered into a multi-RNA target alliance with Takeda Pharmaceutical Company Limited ("Takeda") with the goal to discover and develop RNA targeting small molecule therapeutics for highly attractive targets that are difficult to address via more conventional approaches.

    Evotec and Takeda will jointly identify and develop small molecules targeting a range of RNA targets aligned with Takeda's research and development areas. The collaboration will leverage Evotec's extensive RNA targeting platform to optimally identify promising RNA sequences to target with small molecule ligands that can be developed into potentially first-in-class therapeutics.

    Under the terms of the agreement, Evotec will receive significant research funding and will be eligible to receive discovery, pre-clinical, clinical, commercial and sales milestone payments of up to US$ 160 m per programme. Additionally, Evotec is entitled to tiered royalties on net sales of any products resulting from the collaboration.

    Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: "Many highly validated targets have proven to be intractable via conventional protein targeting approaches. For this reason, Evotec has been pioneering RNA targeting strategies and approaches for quite some time. We are very excited about the opportunity to collaborate with Takeda in this field as both companies share the vision to jointly develop small molecule therapeutics against high value RNA targets that will deliver long awaited therapeutics."

    "Takeda recognizes targeting RNA with small molecules as a promising new modality that has tremendous potential for much needed medicines for patients through modulating historically undruggable targets", said Dr Larry Hamann, Head, Drug Discovery Sciences, Takeda. "We are excited to be working with Evotec and their impressive capabilities."

    About Evotec's RNA platform
    The structure-based recognition of RNA tertiary structures by RNA-targeted small molecules ("rSM") provides an alternative to sequence-based approaches, such as antisense oligonucleotides ("ASOs"). rSM approaches enable novel therapeutic potential by allowing to target highly conserved parts of RNA, creating pathways in cases where the encoded protein cannot be targeted conventionally, and unlocking the largely unexplored field of non-coding RNAs, which can also be disease drivers.

    Evotec's proprietary RNA targeting platform is specifically designed to

    1. identify RNA tertiary structural elements where rSM are able to bind with sufficient selectivity and affinity,
    2. discover and develop suitable rSM binders that potentially deliver orally available drugs, and
    3. identify and deliver proof-of-target engagement for disease-relevant RNA structures, allowing biologically active rSM binders.

    Evotec's cutting-edge RNA small molecule platform builds on the well-established drug discovery routes within Evotec and combines them with novel, highly innovative technologies such as third generation sequencing, sequencing-based structure elucidation of RNA molecules, which constitute a first-class expertise in this area.

    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 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 www.takeda.com.

    ABOUT EVOTEC SE
    Evotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists. We operate worldwide and our more than 3,500 employees provide the highest quality stand-alone and integrated drug discovery and development solutions. We cover all activities from target-to-clinic to meet the industry's need for innovation and efficiency in drug discovery and development (EVT Execute). The Company has established a unique position by assembling top-class scientific experts and integrating state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas including neuronal diseases, diabetes and complications of diabetes, pain and inflammation, oncology, infectious diseases, respiratory diseases, fibrosis, rare diseases and women's health. On this basis, Evotec has built a broad and deep pipeline of more than 100 co-owned product opportunities at clinical, pre-clinical and discovery stages (EVT Innovate). Evotec has established multiple long-term alliances with partners including Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CHDI, Novartis, Novo Nordisk, Pfizer, Sanofi, Takeda, UCB and others. For additional information please go to www.evotec.com and follow us on Twitter @Evotec.

    FORWARD-LOOKING STATEMENTS
    Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of Evotec as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.

    Media Contact Evotec SE:
    Gabriele Hansen, SVP Head of Global Corporate Communications & Marketing, Phone: +49.(0)40.56081-255,

    IR Contact Evotec SE:
    Volker Braun, SVP Head of Global Investor Relations & ESG, Phone: +49.(0)40.56081-775,

    SOURCE: Evotec AG



    View source version on accesswire.com:
    https://www.accesswire.com/636729/Evotec-and-Takeda-Enter-Strategic-RNA-Targeting-Drug-Discovery-and-Development-Alliance

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