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

16.5
-0.43  -3%
Previous Close 16.93
Open 16.82
52 Week Low 15.303
52 Week High 19.965
Market Cap $52,020,800,964
Shares 3,152,775,816
Float 3,152,775,816
Enterprise Value $86,927,924,294
Volume 3,076,039
Av. Daily Volume 2,007,728
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Upcoming Catalysts

Drug Stage Catalyst Date
TAK-721
Eosinophilic esophagitis
PDUFA priority review
PDUFA priority review
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TAK-906
Gastroparesis
Phase 2b
Phase 2b
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Pevonedistat (TAK-924)
Higher-risk myelodysplastic syndromes (HR-MDS)
Phase 3
Phase 3
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Mobocertinib (TAK-788)
Non-small cell lung cancer (NSCLC)
PDUFA priority review
PDUFA priority review
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CABOMETYX (Cabozantinib) - COSMIC-311
Thyroid Carcinoma
sNDA Filing
sNDA Filing
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TAK-755
Immune Thrombotic Thrombocytopenic Purpura (iTTP)
Phase 2
Phase 2
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TAK-609
Hunter Syndrome
NDA Filing
NDA Filing
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TAK-994
Narcolepsy
Phase 2
Phase 2
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CABOMETYX (cabozantinib) + TECENTRIQ (atezolizumab) - (COSMIC-312)
Hepatocellular Carcinoma
Phase 3
Phase 3
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CABOMETYX (Cabozantinib) and OPDIVO (nivolumab)and YERYOY (Ipilimumab) - (COSMIC-313)
Renal Cell Carcinoma
Phase 3
Phase 3
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TAK-755
Congenital Thrombotic Thrombocytopenic Purpura
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Telaglenastat (CB-839) + COMETRIQ (Cabozantinib) - (CANTATA)
Renal cell carcinoma
Phase 2
Phase 2
Phase 2 top-line data did not meet primary endpoint - January 4, 2021.
ICLUSIG (ponatinib)
Chronic Myeloid Leukemia
Approved
Approved
FDA approval announced December 18, 2020.
ADCETRIS (brentuximab vedotin)
Frontline CD30-positive mature T-cell lymphomas - cancer
Approved
Approved
FDA Approval announced November 16, 2018.
ADCETRIS (brentuximab vedotin)
Post-transplant Hodgkin lymphoma (HL) cancer
Approved
Approved
Approved August 17, 2015.
ADCETRIS (brentuximab vedotin)
Hodgkin lymphoma and Anaplastic large cell lymphoma
Approved
Approved
Approval announced August 19, 2011.
ADCETRIS (brentuximab vedotin)
Frontline Hodgkin lymphoma
Approved
Approved
sBLA approval announced March 20, 2018. PDUFA date under priority review was May 1, 2018.
Soticlestat (TAK-935/OV935)
Dravet Syndrome / Lennox-Gastaut Syndrome
Phase 3
Phase 3
Phase 3 trials to commence mid-2021.
CABOMETYX (Cabozantinib)
Medullary thyroid cancer
Approved
Approved
Approved November 29, 2012.
CABOMETYX (Cabozantinib)
Advanced hepatocellular cancer (HCC)
Approved
Approved
FDA Approval announced January 14, 2019.
TAK-041 / NBI-1065846
Anhedonia in depression
Phase 2
Phase 2
Phase 2 trial planned for 2021.
TAK-653 / NBI-1065845
Major Depressive Disorder (MDD)
Phase 2
Phase 2
Phase 2 trial planned for 2021.
TAK-831 / Luvadaxistat (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.
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.
Mobocertinib EXCLAIM-2
NSCLC with EGFR exon 20 insertion mutations
Phase 3
Phase 3
Phase 3 trial is enrolling.

Latest News

    • Delivered Year-over-Year Growth in Reported Revenue of +18.4% and Underlying Revenue of +3.8%, Driven by 14 Global Brands
    • Grew Reported Operating Profit of 248.6 Billion Yen ($2.2B) and Solid Underlying Core Operating Profit Margin of 30.5% While Increasing R&D Investments
    • Paid 242.9 Billion Yen Toward $2.2 Billion of Debt in Q1 and Company Expects to Pre-pay a Total of Approximately 450 Billion Yen (~$4.1B) of Debt in FY2021
    • Anticipated Inflection Year for the Pipeline with Five to Six Regulatory Submissions and Seven New Molecular Entities in Pivotal Studies by Fiscal Year-End
    • Confirms Full-year FY2021 Management Guidance and Forecast

    Takeda Pharmaceutical Company Limited (TYO:4502, NYSE:TAK) ("Takeda") today announced financial…

    • Delivered Year-over-Year Growth in Reported Revenue of +18.4% and Underlying Revenue of +3.8%, Driven by 14 Global Brands
    • Grew Reported Operating Profit of 248.6 Billion Yen ($2.2B) and Solid Underlying Core Operating Profit Margin of 30.5% While Increasing R&D Investments
    • Paid 242.9 Billion Yen Toward $2.2 Billion of Debt in Q1 and Company Expects to Pre-pay a Total of Approximately 450 Billion Yen (~$4.1B) of Debt in FY2021
    • Anticipated Inflection Year for the Pipeline with Five to Six Regulatory Submissions and Seven New Molecular Entities in Pivotal Studies by Fiscal Year-End
    • Confirms Full-year FY2021 Management Guidance and Forecast

    Takeda Pharmaceutical Company Limited (TYO:4502, NYSE:TAK) ("Takeda") today announced financial results for the first quarter of fiscal year 2021 (period ended June 30, 2021). Based on the solid first-quarter results, the Company also confirmed its fiscal year 2021 management guidance and forecast. Fiscal year 2021 remains a year of inflection with Takeda positioned for topline acceleration and continued pipeline progress, including critical regulatory submissions, potential approvals and additional new molecular entities (NMEs) advancing in pivotal studies.

    Costa Saroukos, Chief Financial Officer, commented:

    "With the Shire integration behind us and continued transformation over the last two years, we've pivoted towards accelerating topline growth and investing in R&D to fuel our highly innovative pipeline. Takeda's first-quarter results demonstrate the continued strength of our 14 global brands and, with the business momentum from this strong start to our fiscal year, we remain on track towards our full-year management guidance."

    "FY2021 is an inflection year for our pipeline as we ramp up strategic R&D investments and the pipeline starts to deliver. We anticipate having five to six Wave 1 pipeline regulatory submissions by the end of this fiscal year, with the potential for five approvals by end of H1 FY2022. The resilience of Takeda's business model is a testament to our unwavering commitment to serving patients, our people and the planet. We are focused on discovering and delivering life-transforming treatments to people around the world to create and maximize long-term value for society."

    FINANCIAL AND BUSINESS HIGHLIGHTS

    Results for Q1 FY2021 Ended June 30, 2021

    (billion yen, except percentages and per share amounts)

    REPORTED

    CORE

    (Non-IFRS)(a)

    UNDERLYING(b)

    (Non-IFRS)(a)

    Q1 FY2021

    vs. PRIOR YEAR

    Q1 FY2021

    vs. PRIOR YEAR

    Revenue

    949.6

    +18.4%

    816.6

    +1.8%

    +3.8%

    Operating Profit

    248.6

    +48.6%

    248.9(c)

    -11.4%

    -2.1%

    Margin

    26.2%

    +5.3pp

    30.5%

    -4.5pp

    30.5%

    Net Profit

    200.4

    +142.8%

    176.6

    -7.4%

     

    EPS (JPY)

    128 yen

    +141.9%

    113 yen

    -7.7%

    +3.9%

    Operating Cash Flow

    166.9

    +14.4%

     

     

     

    Free Cash Flow (Non-IFRS)(a)(d)

    129.9

    -11.2%

     

     

     

    (a) Further information on certain of Takeda's Non-IFRS measures is posted on Takeda's investor relations website at https://www.takeda.com/investors/financial-results/.

    (b) Underlying growth compares two periods (quarters or years) of financial results under a common basis and is used by management to assess the business. These financial results are calculated on a constant currency basis and excluding the impact of divestitures and other amounts that are unusual, non-recurring items or unrelated to our ongoing operations.

    (c) Core Operating Profit represents net profit adjusted to exclude income tax expenses, the share of profit or loss of investments accounted for using the equity method, finance expenses and income, other operating expenses and income, amortization and impairment losses on acquired intangible assets and other items unrelated to Takeda's core operations, such as non-recurring items, purchase accounting effects and transaction related costs.

    (d) Free Cash Flow represents cash flows from operating activities, excluding acquisition of plant, property and equipment, intangible assets and investments, and any other cash that is not available to Takeda's immediate or general business use, and including proceeds from sales of property, plant, sales and redemption of investments and businesses, net of cash and cash equivalents divested.

    https://www.takeda.com/investors/financial-results/

    Reported Revenue increased +18.4% to 949.6 billion yen ($8.6B); Underlying Core Revenue increased +3.8% vs. FY2020 Q1, driven by the 14 global brands

    • Takeda's 14 global brands, with an aggregate reported revenue of 335.6 billion yen ($3.0B), posted year-over-year underlying revenue growth of +6.8% despite quarterly phasing headwinds for TAKHZYRO and IG. Takeda's 5 key business areas with 708.0 billion yen ($6.4B) in reported revenue represented 87% of core revenues1.
      • GI with 210.5 billion yen ($1.9B) in reported revenue, with underlying revenue growth of +8% spearheaded by gut-selective ENTYVIO.
      • Rare Diseases with 155.5 billion yen ($1.4 B) in reported revenue declining -3% on an underlying basis, with HAE growth impacted by phasing, but remains in line with the current plan.
      • Plasma Derived Therapy (PDT) Immunology with 107.2 billion yen ($1.0B) in reported revenue declining -2% on an underlying basis, impacted by quarterly phasing of Immunoglobulin products, with full-year outlook unchanged.
      • Oncology with 121.4 billion yen ($1.1B) in reported revenue, with underlying revenue growth +9% driven by indication expansion across the portfolio.
      • Neuroscience with 113.4 billion yen ($1.0B) in reported revenue, with underlying revenue growth +3% driven by strong rebound of Vyvanse following impact of COVID-19 in the prior year.

    ------------------------

    1 Percentage of sales are based on Core revenue; adjusted to remove JPY 133.0B from sale of Japan diabetes portfolio recorded in revenue

    Reported Operating Profit increased 48.6% Underlying Core Operating Profit Margin was 30.5% for Q1

    • Reported operating profit increased 48.6% to 248.6 billion yen ($2.2B) compared to FY2020 Q1, driven by a gain on the sale of the diabetes portfolio in Japan, lower purchase price accounting expenses and lower integration costs. These items more than offset a decrease in other operating income due to a one-time gain recorded in FY2020 Q1.
    • Underlying core operating profit for the current period declined -2.1% reflecting an increase in R&D investment and is expected to recover to "mid-single digit" growth for the full year.
    • Continued progress in debt pre-payment with approximately 242.9 billion yen toward $2.2 billion paid in FY2021 Q1.

    Achieved several critical pipeline milestones to date in FY2021

    • Moderna's COVID-19 Vaccine, approved in Japan for adults in May and expanded age indication to adolescents 12+ years old in July, with distribution underway.
    • Mobocertinib (TAK-788) filing under review in US, China, and other countries.
    • Maribavir's (TAK-620) filing and acceptance in the US and EU, with FDA granting priority review.
    • Orexin (TAK-994) granted Breakthrough Therapy designation by the FDA for Narcolepsy Type 1.
    • TAK-999 granted Breakthrough Therapy designation by the FDA for AATD2 Liver Disease
    • Collaboration with Frazier Healthcare Partners to launch HilleVax, Inc., a biopharmaceutical company to develop and commercialize TAK-214, Takeda's norovirus vaccine candidate.

    ------------------------

    2 AATD = Alpha-1 antitrypsin deficiency

    Important recognition in Q1

    • Two of Takeda's facilities in Japan and Ireland were recognized by the International Society for Pharmaceutical Engineering (ISPE) with the 2021 Facility Of the Year Awards for the use of digital and innovative technologies to enhance manufacturing capabilities.

    FY2021 Guidance

    On track towards full-year FY2021 guidance (Unchanged from May 2021)

    (billion yen)

    FY2021

    CURRENT

    FORECAST

    Underlying

    Management Guidance

    Revenue

    3,370.0

    Mid-single-digit growth

    R&D Expenses

    -522.0

     

    Reported Operating Profit

    488.0

     

    Core Operating Profit

    930.0

    Mid-single-digit growth

    Reported EPS (Yen)

    160

     

    Core EPS (Yen)

    394

    Mid-single-digit growth

    Free Cash Flow

    600-700

     

    Annual Dividend per Share (Yen)

    180

     

     

    Key assumptions in FY2021 forecast

    Company guidance reflects management's expectations for continued business momentum across Takeda's five key business areas, underlying revenue growth of its 14 global brands, and accelerated realization of cost synergies, while continuing to invest in R&D.

    FY2021 guidance reflects the following key assumptions, including (1) Takeda expects at least one 505(b)2 competitor for subcutaneous VELCADE to launch in the U.S. around mid FY2021; (2) Takeda does not expect to restart sales of Natpara in the U.S. market in FY2021; and (3) FY2021 guidance does not include the impact of any potential further divestitures beyond what has already been disclosed by Takeda.

    To date, Takeda has not experienced a material effect on its financial results as a result of the global spread of the novel coronavirus infectious disease (COVID-19). Based on currently available information, Takeda believes that its financial results for FY2021 will not be materially affected by COVID-19 and, accordingly, Takeda's FY2021 forecast reflects this belief. However, the situation surrounding COVID-19 remains highly fluid, and future COVID-19-related developments in FY2021, including new or additional COVID-19 outbreaks and additional or extended lockdowns, shelter-in-place orders or other government action in major markets, could result in further or more serious disruptions to Takeda's business, such as slowdowns in demand for Takeda's products, supply chain related issues or significant delays in its clinical trial programs. These events, if they occur, could result in an additional impact on Takeda's business, results of operations or financial condition, as well as result in significant deviations from Takeda's FY2021 forecast.

    For more details on Takeda's Q1 FY2021 results and other financial information, please visit: https://www.takeda.com/investors/financial-results/

    More information on Takeda's Environmental, Social and Governance (ESG) approach and values-based corporate governance can be found in the 2021 Annual Integrated Report for FY2020, which ended March 31, 2021. This report can be accessed on Takeda's website at: https://air.takeda.com.

    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 and regions. 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.

    The product names appearing in this document are trademarks or registered trademarks owned by Takeda, or their respective owners.

    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.

    Financial information

    Takeda's financial statements are prepared in accordance with International Financial Reporting Standards ("IFRS"). Convenience translations of JPY figures into USD are included for reference and have been calculated at a rate of JPY/USD of 111.05.

    Certain Non-IFRS Financial Measures

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

    Further information on certain of Takeda's Non-IFRS measures is posted on Takeda's investor relations website at https://www.takeda.com/investors/financial-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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  1. Takeda Will Focus its Efforts on Dengue, Zika and Pandemic Vaccines

    Takeda Pharmaceutical Company Limited ((TAK) (Takeda) and Frazier Healthcare Partners (Frazier) today announced a collaboration to launch HilleVax, Inc. (HilleVax), a biopharmaceutical company to develop and commercialize Takeda's norovirus vaccine candidate. Takeda has granted a license to HilleVax for the exclusive development and commercialization rights to its norovirus vaccine candidate, HIL-214 (formerly TAK-214), worldwide outside of Japan, in exchange for upfront consideration, as well as future cash milestones and royalties on net sales. Takeda will retain commercialization rights in Japan and HilleVax will integrate certain Japan development activities into its global…

    Takeda Will Focus its Efforts on Dengue, Zika and Pandemic Vaccines

    Takeda Pharmaceutical Company Limited ((TAK) (Takeda) and Frazier Healthcare Partners (Frazier) today announced a collaboration to launch HilleVax, Inc. (HilleVax), a biopharmaceutical company to develop and commercialize Takeda's norovirus vaccine candidate. Takeda has granted a license to HilleVax for the exclusive development and commercialization rights to its norovirus vaccine candidate, HIL-214 (formerly TAK-214), worldwide outside of Japan, in exchange for upfront consideration, as well as future cash milestones and royalties on net sales. Takeda will retain commercialization rights in Japan and HilleVax will integrate certain Japan development activities into its global development. Takeda remains committed to vaccines, and this collaboration allows Takeda to focus its global resources on dengue, COVID-19, pandemic influenza and Zika, in addition to the vaccines it currently distributes in Japan.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210729005286/en/

    HIL-214, which is a virus-like particle (VLP) based vaccine candidate, completed a randomized, placebo-controlled Phase 2b field efficacy study in 4,712 adult subjects in which HIL-214 was well-tolerated and demonstrated clinical proof of concept in preventing moderate-to-severe cases of acute gastroenteritis from norovirus infection.1 To date, the candidate has been studied in nine human clinical trials with safety data from over 4,500 subjects and immunogenicity data from over 2,000 subjects.

    "Takeda and Frazier have a history of successfully partnering together, and we are confident in HilleVax's capabilities to progress HIL-214, the most advanced norovirus vaccine candidate in development with the potential to address the huge global burden of norovirus-associated acute gastroenteritis," said Rajeev Venkayya, M.D., President of the Global Vaccine Business Unit, Takeda. "This will allow Takeda to focus its efforts and resources on our dengue vaccine, which we have begun filing for licensure around the world, our pandemic programs, and our partnership with the US Government to develop a Zika vaccine."

    Norovirus is a common intestinal infection marked by diarrhea, vomiting, abdominal cramps, nausea and sometimes fever that may lead to clinically significant dehydration.2 Norovirus is recognized as the leading cause of acute gastroenteritis across the age spectrum.3 It is estimated that norovirus causes nearly 700 million cases of illness and more than 200,000 deaths worldwide per year with significant additional economic and social burden.3 No vaccines are currently approved for norovirus infection, and HIL-214 continues to be the most advanced norovirus vaccine candidate in human clinical trials.

    "Following our successful partnership to form Phathom Pharmaceuticals, we are extremely pleased to partner again with Takeda to form HilleVax," said Tachi Yamada, M.D., co-founder of HilleVax and Venture Partner with Frazier. "Norovirus causes significant morbidity and mortality as well as tremendous economic and social costs worldwide. We believe that HIL-214 represents an important opportunity to address this immense unmet need."

    Takeda's Commitment to Vaccines

    Vaccines prevent 2 to 3 million deaths each year and have transformed global public health. For more than 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, pandemic influenza and Zika. Takeda's team brings an outstanding track record and a wealth of knowledge in vaccine development and manufacturing 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 and regions. For more information, visit https://www.takeda.com.

    About Frazier Healthcare Partners

    Founded in 1991, Frazier Healthcare Partners is a leading provider of growth and venture capital to healthcare companies. With nearly $4.8 billion total capital raised, Frazier has invested in over 200 companies, with investment types ranging from company creation and venture capital to buyouts of profitable lower-middle market companies. The firm's Growth Buyout team invests in healthcare and pharmaceutical services, medical products and related sectors. The Life Sciences team invests in therapeutics and related areas that are addressing unmet medical needs through innovation. Frazier has offices in Seattle, WA and Menlo Park, CA, and invests broadly across the US, Canada, and Europe. For more information about Frazier Healthcare Partners, visit the company's website at http://www.frazierhealthcare.com.

    About HilleVax

    HilleVax is a biopharmaceutical company focused on the development and commercialization of novel vaccine candidates. Its initial program, HIL-214, is a virus-like particle (VLP) based vaccine candidate in development for the prevention of moderate-to-severe acute gastroenteritis caused by norovirus infection. For more information about HilleVax, visit the company's website at http://www.HilleVax.com.

    Takeda Pharmaceutical Company Limited 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.

    References

    1 Sherwood J, et al. Vaccine 2020; 38(41):6442-6449

    2 https://www.cdc.gov/norovirus/index.html [accessed 2021 April 27].

    3 Hall AJ, et al. Expert Rev Vaccines 2016;15(8):949-951

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  2. – If Approved, Investigational TAK-994 May Provide a Future Treatment Option Targeting the Orexin Deficiency Underlying NT1

    Takeda Pharmaceutical Company Limited ((TAK) ("Takeda") today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to TAK-994,1 its Phase 2 investigational oral orexin agonist, which is designed to selectively target orexin 2 receptors. TAK-994 is currently being studied for the treatment of excessive daytime sleepiness (EDS) in patients with narcolepsy type 1 (NT1),2 a chronic neurological disorder that alters the sleep-wake cycle.3 EDS is a hallmark symptom of NT1 and is characterized by a person's inability to stay awake and alert throughout the day, and falling…

    – If Approved, Investigational TAK-994 May Provide a Future Treatment Option Targeting the Orexin Deficiency Underlying NT1

    Takeda Pharmaceutical Company Limited ((TAK) ("Takeda") today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to TAK-994,1 its Phase 2 investigational oral orexin agonist, which is designed to selectively target orexin 2 receptors. TAK-994 is currently being studied for the treatment of excessive daytime sleepiness (EDS) in patients with narcolepsy type 1 (NT1),2 a chronic neurological disorder that alters the sleep-wake cycle.3 EDS is a hallmark symptom of NT1 and is characterized by a person's inability to stay awake and alert throughout the day, and falling asleep unintentionally or at inappropriate times on a daily basis.3,4

    The FDA's Breakthrough Therapy Designation process is designed to expedite the development and review of a drug that is intended to treat a serious condition, for which preliminary clinical evidence exists indicating it may demonstrate a substantial improvement over available therapies on at least one clinically significant endpoint.5

    The TAK-994 BTD was based, in part, on early phase and preliminary clinical data that indicates Takeda's investigational oral orexin agonist may demonstrate substantially improved objective and subjective measurements of daytime wakefulness in NT1 patients.1 Currently, TAK-994 is being studied in an ongoing Phase 2 (TAK-994-1501) study.2 Data from the completed Phase 2 study will be presented at a future scientific conference after the study's conclusion.

    "Individuals with narcolepsy type 1 suffer from excessive daytime sleepiness, which might mean routinely falling asleep at work or in school. If approved, investigational TAK-994 has the potential to transform the way we currently treat NT1 by addressing the underlying orexin deficiency central to the disease," said Sarah Sheikh, Head, Neuroscience Therapeutic Area Unit at Takeda. "Orexin plays a critical role in regulating a person's sleep wake cycle, and supports the body's natural wake promoting pathways in the brain."

    Investigational TAK-994, which was discovered at Takeda's laboratories in Shonan, Japan, part of the open innovation center at the Shonan Health Innovation Park, is the lead candidate in Takeda's pioneering multi-asset orexin-focused franchise. This designation marks a key milestone in Takeda's accelerated development efforts to bring this important potential therapy to patients with NT1.

    Takeda's Commitment to Neuroscience

    Takeda Neuroscience is driven by the unmet need of patients with neurologic and psychiatric diseases. Our mission is to bring innovative and potentially disease-modifying medicines to these individuals. Our dedication extends beyond our marketed products and research efforts. We are committed to raising awareness for these conditions, building strategic partnerships with both industry and advocacy, educating patients and physicians, and broadening access to therapies.

    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 Genetics 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.

    References

    1. Data on File. Takeda Pharmaceuticals. 2021.
    2. A Study of TAK-994 in Participants With Narcolepsy With or Without Cataplexy (Narcolepsy Type 1 [NT1] or Narcolepsy Type 2 [NT2]). ClinicalTrials.gov. Published April 1, 2021. https://clinicaltrials.gov/ct2/show/NCT04096560
    3. Ruoff C, Rye D. The ICSD-3 and DSM-5 guidelines for diagnosing narcolepsy: clinical relevance and practicality. Curr Med Res Opin. 2016;32(10):1611-1622. doi:10.1080/03007995.2016.1208643
    4. Brown J, Makker H. An approach to excessive daytime sleepiness in adults. BMJ. 2020;(368):m1047.
    5. Breakthrough Therapy. FDA. Published online November 3, 2018. Accessed July 23, 2021. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy

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  3. Data Include Phase 3 Results Showing that the Primary Endpoint of Spontaneous, Treated Annualized Bleeding Rates During Prophylaxis with Recombinant von Willebrand Factor in Adults with von Willebrand Disease, was Met

    12 Abstracts Presented Across Takeda's Hematology Portfolio and Pipeline Support Takeda's Commitment to Improving Patient Care Today as well as Transforming Future Care

    Takeda Pharmaceutical Company Limited ((TAK) ("Takeda") today announced the results of a phase 3 trial investigating the efficacy and safety of recombinant von Willebrand factor (rVWF) prophylaxis,1 one of the 12 abstracts being presented at the International Society on Thrombosis and Haemostasis (ISTH) Virtual Congress 2021. Several of these abstracts explored…

    Data Include Phase 3 Results Showing that the Primary Endpoint of Spontaneous, Treated Annualized Bleeding Rates During Prophylaxis with Recombinant von Willebrand Factor in Adults with von Willebrand Disease, was Met

    12 Abstracts Presented Across Takeda's Hematology Portfolio and Pipeline Support Takeda's Commitment to Improving Patient Care Today as well as Transforming Future Care

    Takeda Pharmaceutical Company Limited ((TAK) ("Takeda") today announced the results of a phase 3 trial investigating the efficacy and safety of recombinant von Willebrand factor (rVWF) prophylaxis,1 one of the 12 abstracts being presented at the International Society on Thrombosis and Haemostasis (ISTH) Virtual Congress 2021. Several of these abstracts explored the use of prophylaxis as part of Takeda's commitment to improving outcomes for patients with rare bleeding disorders.

    The prospective, phase 3, open-label, international multicenter study included 23 patients with severe von Willebrand disease (VWD). The study period was 12 months and included two arms; the prior on-demand (OD) group included patients previously taking OD VWF and the switch group included patients previously taking prophylactic plasma-derived von Willebrand factor (pdVWF) treatment [LPB0128]. Results showed that prophylaxis with rVWF effectively reduced spontaneous, treated annualized bleeding rates (sABRs) in patients previously treated OD, and the same level of hemostatic control was maintained in patients who switched from prophylaxis with pdVWF. The sABR was reduced by 91.5% on study (while receiving prophylactic rVWF) compared with historical sABR in prior OD patients, and sABR was maintained on-study in switch patients (sABR on-study: historical ratio (95% CI): 0.09 (0.02, 0.35) in prior OD arm; 0.55 (0.09, 3.52) in switch arm). No new risks were identified, with no serious adverse events related to rVWF reported.1 The pharmacokinetics (PK) of VWF:ristocetin cofactor (VWF:RCo) and FVIII pharmacodynamics (PD) [PB0917] were also studied and presented at the congress.2

    "Stopping a bleed in VWD does not prevent subsequent bleeds, and the complications and unpredictable nature of these bleeds for many OD treated patients can impact their daily life," commented Dr. Flora Peyvandi, Director of the Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda Ospedale Maggiore, Policlinico, University of Milan, Italy. "These exciting phase 3 results are important in improving understanding about the potential benefit of prophylaxis with rVWF and what this may offer patients with VWD in reducing spontaneous bleeds in the future."

    A literature review being presented at ISTH 2021 also studied the rates of bleeding-related complications, quality of life and healthcare resource utilization in VWD [PB0924].3 Data gathered from a further retrospective cohort study investigating the characteristics and management of patients with VWD in UK general practice discussed the occurrence of bleeding events in patients with a mild disease status [PB0927].4

    Additional investigational data across Takeda's hematology portfolio assessed the efficacy and safety of PK-guided prophylaxis in patients with hemophilia A. Results from the real-world German AHEAD study, which aims to examine long-term effectiveness and safety of antihemophilic factor (recombinant), rAHF (ADVATE),5 help to provide an understanding of the bleeding rates in patients with hemophilia A receiving PK-guided prophylaxis versus standard prophylaxis [PB0509].6 PK-guided prophylaxis was further studied in another real-world analysis using data from the CHESS II database to assess the impact on clinical and health resource utilization outcomes [PB0554].7 Data from a post hoc analysis of the PROPEL phase 3 study on the effects of PK-guided prophylaxis targeting specific FVIII trough levels with rurioctocog alfa pegol (ADYNOVATE) were also presented at the congress [PB0542].8

    "At Takeda we are committed to helping make a difference to the lives of patients with rare hematological disorders, both today through our broad portfolio of treatments, and in the future by developing innovative solutions to address unmet needs," commented Wolfhard Erdlenbruch, MD, Head, Global Medical Affairs Hematology. "The data presented at ISTH 2021 highlights the potential for rVWF to address unmet needs in VWD, as well as helping us to understand the clinical and resource utilization impact when individualizing treatment through PK-guided prophylaxis in hemophilia."

    Also featured at the congress was the phase 3 study design exploring TAK-755, an investigational recombinant ADAMTS13 replacement therapy being studied for use as prophylactic and OD treatment for patients with severe congenital thrombotic thrombocytopenic purpura (cTTP) [PB0837],9 and an abstract which reviewed the clinical burden of TTP [PB0843].10 Improving awareness and understanding around this rare and life-threatening blood disorder associated with ADAMTS13 deficiency,9 together with the development of TAK-755, forms part of Takeda's commitment to invest in research that has the potential to transform the future care of even more patients affected by rare hematological disorders.

    ###

    About the Phase 3 Recombinant von Willebrand Factor Study

    In the prior OD group, subjects initiated rVWF prophylactic treatment with twice-weekly infusions of 50±10 IU/kg per infusion. In the switch group, subjects initiated rVWF prophylactic treatment based on matching (±10%) the weekly dose of their prior pdVWF prophylaxis regimen.

    23 enrolled patients received rVWF prophylaxis (prior OD arm: n=13; switch arm: n=10) and 18/23 (78.3%) patients had type 3 VWD. Over the 12-month study period, 11/13 (84.6%) prior OD patients and 7/10 (70.0%) switch patients had a treated, sABR of zero, whereas, historically, 13/13 prior OD and 1/10 switch patients had an sABR >2. Benefit-risk profile was maintained, with no newly identified risks. One adverse event, a headache of moderate severity, was considered possibly related to rVWF by the investigator and led to discontinuation of rVWF and study withdrawal.

    About von Willebrand Disease (VWD)

    VWD is the most common inherited bleeding disorder, affecting up to one percent of the U.S. population.11 VWD is caused by a deficiency or dysfunction of VWF, one of several types of proteins in the blood that are needed to facilitate proper blood clotting.11 Due to this defect or deficiency in VWF, blood is not able to clot effectively in people with VWD, resulting in prolonged bleeding.11 There is a broad spectrum of disease severity, however, severe bleeding can occur in anyone living with VWD.12

    About Hemophilia

    Hemophilia is a chronic disease that causes longer-than-normal bleeding due to absent or deficient clotting factor in the blood.13 Hemophilia A is more common than hemophilia B; in 2018, hemophilia A affected about 173,711 people, whereas hemophilia B affected about 34,289 people worldwide.14

    People with hemophilia, working closely with their healthcare professionals, can live healthy lives with proper care and adequate treatment.15 Treatment regimens typically include on-demand and/or regular prophylactic infusions of factor replacement therapy to control or prevent the risk of bleeding.16

    About Takeda Hematology

    Following its recent acquisition of Shire, Takeda is a leader in hemophilia with the longest heritage and market-leading portfolio, backed by established safety and efficacy profiles with decades of real-world experience. We have 70+ years driving innovation for patients17 and a broad portfolio of 11 products across multiple bleeding disorders.18 Our experience as a leader in hematology means we are well prepared to meet today's needs as we pursue future developments in the care of blood disorders. Together with the hematology community, we are raising expectations for the future, including earlier diagnosis, earlier and full protection against bleeds, and more personalized patient care.

    About VEYVONDI/VONVENDI

    In Europe, VEYVONDI is indicated in adults (age 18 and older) with von Willebrand disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or not indicated for the treatment of hemorrhage and treatment/prevention of surgical bleeding. VEYVONDI should not be used in the treatment of hemophilia A.

    For full EU Summary of Product Characteristics, including approved indication(s) and important safety information, please visit here.

    In the US the product has been approved under the trade name VONVENDI® [von Willebrand factor (Recombinant)] and is indicated for use in adults (age 18 and older) diagnosed with VWD for on-demand treatment and control of bleeding episodes or perioperative management of bleeding.

    VEYVONDI SAFETY INFORMATION FOR EUROPE

    Please consult the VEYVONDI Summary Product Characteristics (SmPC) here before prescribing.

    Contraindications

    Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SmPC.

    Known allergic reaction to mouse or hamster proteins.

    Warnings and Precautions

    In actively bleeding patients it is recommended to co-administer a FVIII product with VEYVONDI as a first line treatment and depending on the FVIII activity levels (see 4.2 of the SmPC).

    Hypersensitivity reactions (including anaphylaxis) have occurred. Patients and/or their caregivers should be informed of the early signs of hypersensitivity reactions, which may include but are not limited to tachycardia, tightness of the chest, wheezing and/or acute respiratory distress, hypotension, generalised urticaria, pruritus, rhinoconjunctivitis, angioedema, lethargy, nausea, vomiting, paresthesia, restlessness, and may progress to anaphylactic shock.

    VEYVONDI contains trace amounts of mouse immunoglobulin G (MuIgG) and hamster proteins (less than or equal to 2 ng/IU VEYVONDI). VEYVONDI contains trace amounts of recombinant coagulation factor VIII.

    There is a risk of occurrence of thrombotic events, particularly in patients with known clinical or laboratory risk factors for thrombosis including low ADAMTS13 levels.

    In patients requiring frequent doses of VEYVONDI in combination with recombinant factor VIII, plasma levels for FVIII:C activity should be monitored to avoid sustained excessive FVIII:C plasma levels, which may increase the risk of thrombotic events. Any FVIII that would be administered along with VEYVONDI should be a pure FVIII product.

    Patients with VWD, especially Type 3, may develop neutralising antibodies (inhibitors) to von Willebrand factor. If the expected plasma levels of (VWF:RCo) are not attained, or if bleeding is not controlled with an appropriate dose, an appropriate assay should be performed to determine if a von Willebrand factor inhibitor is present.

    This medicinal product contains 5.2 mg sodium in each 650 IU vial or 10.4 mg sodium in each 1300 IU vial. This is equivalent to 2.2% of the WHO recommended maximum daily intake of 2 g sodium for an adult, assuming a body weight of 70 kg and a dose of 80 IU/kg body weight. This is to be taken into consideration by patients on a controlled sodium diet.

    Adverse Reactions

    During treatment with VEYVONDI, the following adverse reactions may occur: hypersensitivity or allergic reactions, thromboembolic events, inhibitor formation against VWF.

    The following adverse reactions, grouped by MedDRA SOC and frequency, were reported in clinical trials, post-authorisation safety studies, or post-marketing reporting: dizziness, vertigo, dysgeusia, tremor, tachycardia, deep venous thrombosis, hypertension, hot flush, vomiting, nausea, pruritus generalized, chest discomfort, infusion site paraesthesia, electrocardiogram T wave inversion, heart rate increased (common ≥ 1/100 to < 1/10), infusion-related reaction, anaphylactic reaction (frequency not known).

    Description of selected adverse reactions

    In clinical trials, one case of clinically asymptomatic deep vein thrombosis (DVT) was reported for a subject in the surgery study who had total hip replacement.

    In addition, one post-marketing case of DVT has been reported spontaneously for an elderly patient.

    For more information, please refer to the VEYVONDI Summary of Product Characteristics here.

    For US specific safety information, please refer to the VONVENDI US Prescribing Information here.

    E.U. Indication and Important Safety Information

    About ADVATE (human coagulation factor VIII (rDNA), octocog alfa)

    Please consult the ADVATE Summary of Product Characteristics (SmPC) before prescribing, particularly in relation to dosing and treatment monitoring (here).

    Contraindications

    Hypersensitivity to the active substance or to any of the excipients listed in the SmPC or to mouse or hamster proteins.

    Special warnings and precautions for use

    The product contains traces of mouse and hamster proteins. If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the product immediately and contact their physician.

    Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.

    The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per mL of plasma using the modified assay.

    In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests. If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor presence should be performed.

    This medicinal product contains 10mg sodium per vial, equivalent to 0.5% of the World Health Organisation recommended maximum daily intake of 2g sodium for an adult.

    Adverse Reactions

    Very common (≥1/10)

    Factor VIII inhibition in previously untreated patients (PUPs)

    Common (≥1/100 to <1/10)

    Headache, Pyrexia

    Uncommon (≥1/1000 to <1/100)

    Influenza, Laryngitis, Factor VIII inhibition in previously treated patients (PTPs), Lymphangitis, Dizziness, Dysgeusia, Memory impairment, Migraine, Syncope, Tremor, Eye inflammation, Palpitations, Haematoma, Hot flush, Pallor, Dyspnoea, Abdominal pain upper, Diarrhoea, Nausea, Vomiting, Hyperhidrosis, Pruritus, Rash, Urticaria, Chest discomfort, Chest pain, Chills, Feeling abnormal, Peripheral oedema, Vessel puncture site haematoma, Coagulation factor VIII level decreased, Haematocrit decreased, Laboratory test abnormal, Monocyte Count increased, Post procedural complication, Post procedural haemorrhage, Procedural site reaction

    Not known

    Anaphylactic reaction, Hypersensitivity, Fatigue, Injection site reaction, Malaise

     

    For the ADVATE US Prescribing Information, please refer here.

    About ADYNOVATE/ADYNOVI®▼ (Pegylated human coagulation factor VIII (rDNA), rurioctocog alfa pegol)

    Detailed Safety Information

    Please consult the ADYNOVI Summary of Product Characteristics (SmPC) before prescribing, particularly in relation to dosing and treatment monitoring (here)

    Contraindications

    Hypersensitivity to the active substance, to the parent molecule octocog alfa or to any of the excipients listed in the SmPC. Known allergic reaction to mouse or hamster protein

    Special warnings and precautions for use

    The medicinal product contains traces of mouse and hamster proteins. If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.

    The formation of neutralising antibodies (inhibitors) against factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per mL of plasma using the modified assay.

    In general, all patients treated with coagulation factor VIII should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests. If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor presence should be performed.

    This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodiumfree'.

    Adverse Reactions

    Very common (≥1/10)

    Headache

    Common (≥1/100 to <1/10)

    Dizziness, Diarrhoea, Nausea, Rash

    Uncommon (≥1/1000 to <1/100)

    Factor VIII inhibition in previously-treated patients (PTPs), Hypersensitivity, Ocular hyperaemia, Flushing, Drug eruption, Eosinophil count increased, Infusion related reaction

    For the ADYNOVATE US Prescribing Information, please refer here.

    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.

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    1 ISTH 2021. Abstract [LPB0128]. Phase 3 Trial Results: Prophylaxis With Recombinant Von Willebrand Factor in Patients With Severe von Willebrand Disease.

    2 ISTH 2021. Abstract [PB0917]. Pharmacokinetics/Pharmacodynamics (PK/PD) of Recombinant von Willebrand Factor (vonicog alfa) in Adult Patients with von Willebrand Disease (VWD) During Prophylactic Treatment.

    3 ISTH 2021. Abstract [PB0924]. Burden of Illness in Patients with von Willebrand Disease: A Systematic Review.

    4 ISTH 2021. Abstract [PB0927]. Characteristics and Treatment of Patients with von Willebrand Disease (VWD) in General Practice Settings in the United Kingdom.

    5 German Clinical Trials Register. DRKS-ID: DRKS00000556. Available at: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00000556. Last accessed: June 2021.

    6 ISTH 2021. Abstract [PB0509]. Does Pharmacokinetic-guided Prophylaxis with Antihemophilic Factor (Recombinant) Improve Bleeding Rates over Standard Prophylaxis? Real-world Data from the AHEAD German Study.

    7 ISTH 2021. Abstract [PB0554]. The Impact of PK-guided Prophylaxis on Clinical Outcomes and Resource Utilization in Hemophilia A Patients: Real-world Evidence From the CHESS II Study.

    8 ISTH 2021. Abstract [PB0542]. Looking Beyond Fixed-Dose Rurioctocog Alfa Pegol Prophylaxis: Post hoc Analysis of PK-guided Regimens From the PROPEL Phase 3 Study.

    9 ISTH 2021. Abstract [PB0837]. Design of a phase 3, randomized, controlled study of prophylactic and on-demand treatment with recombinant ADAMTS13 for patients with severe congenital thrombotic thrombocytopenic purpura.

    10 ISTH 2021. Abstract [PB0483]. The Clinical Burden of Congenital and Immune-mediated Thrombotic Thrombocytopenic Purpura: A Retrospective Cohort Analysis.

    11 National Hemophilia Foundation. Von Willebrand Disease. Available at:https://www.hemophilia.org/bleeding-disorders-a-z/types/von-willebrand-disease. Last accessed June 2021.

    12 Connell NT, et al. ASH ISTH NHF WFH 2021 Guidelines on the Management of von Willebrand Disease. Blood Adv (2021) 5 (1): 301–325.

    13 World Federation of Hemophilia. Introduction to Hemophilia: What is Hemophilia? Available at: https://bit.ly/356zUDQ. Last accessed June 2021.

    14 20 Anniversary Report on the Annual Global Survey 2018. World Federation of Hemophilia. Available at: https://bit.ly/3hGDUzU. Last accessed June 2021.

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    Copyright 2021 Takeda Pharmaceutical Company Limited. All rights reserved. Takeda and the Takeda logo are registered trademarks of Takeda Pharmaceutical Company limited.

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  4. Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Ministry of Health, Labour and Welfare of Japan (MHLW) and Takeda Pharmaceutical Company Limited (NYSE:TAK) have agreed to purchase and distribute an additional 50 million doses of Moderna's COVID-19 vaccine and its updated variant booster vaccine candidate, if authorized, to begin delivery in 2022.

    This new supply agreement is in addition to the prior agreement for 50 million doses in 2021 resulting in a total of 100 million doses for Japan. Moderna is responsible for the manufacture and supply of Moderna's vaccine candidate, and Takeda, with the support of the MHLW and Moderna, is responsible for all import…

    Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Ministry of Health, Labour and Welfare of Japan (MHLW) and Takeda Pharmaceutical Company Limited (NYSE:TAK) have agreed to purchase and distribute an additional 50 million doses of Moderna's COVID-19 vaccine and its updated variant booster vaccine candidate, if authorized, to begin delivery in 2022.

    This new supply agreement is in addition to the prior agreement for 50 million doses in 2021 resulting in a total of 100 million doses for Japan. Moderna is responsible for the manufacture and supply of Moderna's vaccine candidate, and Takeda, with the support of the MHLW and Moderna, is responsible for all import, local regulatory, development and distribution activities in Japan for these additional 50 million doses beginning in 2022.

    "We thank the MHLW and Takeda for their support and for partnering with us to bring our mRNA COVID-19 vaccine to Japan," said Stéphane Bancel, Moderna's Chief Executive Officer. "We remain committed to making our vaccine available around the world as we seek to address the pandemic."

    About Moderna

    In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

    Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 15 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

    Forward Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the Company's development of a vaccine to protect against the SARS-CoV-2 virus (mRNA-1273, also referred to as the Moderna COVID-19 Vaccine), as well as booster vaccine candidates; the Company's agreement to supply the vaccine to the government of Japan; the arrangements between the Company, Takeda and Japanese regulatory authorities for the importation of the vaccine; and the anticipated number of doses and timing for delivery of vaccine supply. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

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