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    Takeda to Manufacture and Provide 150 Million Doses of Novavax’ COVID-19 Vaccine Candidate to the Government of Japan

    September 7, 2021

    OSAKA, Japan, September 7, 2021 – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the Government of Japan’s Ministry of Health, Labour and Welfare (MHLW) will purchase 150 million doses of Novavax’ vaccine candidate (TAK-019 in Japan) manufactured in Japan by Takeda subject to licensing and approval. The details of the terms and conditions of the agreement are confidential.

    As part of a previously announced agreement with Novavax, Takeda is establishing the capability to manufacture TAK-019 (known outside Japan as NVX-CoV2373) at its facilities in Japan and aims to begin distribution in early calendar year 2022. Novavax is licensing and transferring manufacturing technologies to enable Takeda to manufacture the vaccine antigen and is supplying the Matrix-M TM adjuvant to Takeda for fill/finish together with the antigen. Takeda is responsible for the Japanese clinical trial and regulatory submission to the Pharmaceuticals and Medical Devices Agency (PMDA) and will distribute TAK-019 in Japan should it be approved by the MHLW.

    Takeda’s efforts to transfer technology, establish production facilities and distribute Novavax’ vaccine candidate in Japan are supported by the MHLW under its supplementary budget for emergency maintenance associated with the vaccine production system.

    The impact of this agreement on Takeda’s forecast for the fiscal year ending March 31, 2022 (FY2021) will depend on the exact timing of distribution. Takeda will update its FY2021 forecast at the appropriate timing, as necessary, also taking other factors into consideration.

    About Takeda’s COVID-19 Efforts
    Takeda is taking a comprehensive approach to treat and prevent COVID-19 today, and future pandemics through multiple activities and partnerships including, but not limited to: 

    • Vaccines: Takeda has partnered with the Government of Japan, Novavax and Moderna, to help accelerate the availability of COVID-19 vaccines. Through the collaboration with Novavax, Takeda will build on its well-established global manufacturing and supply capabilities and be responsible for developing and commercializing Novavax’ vaccine candidate. The company is also importing and distributing Moderna’s COVID-19 vaccine as part of a three-way partnership with Moderna and the Government of Japan’s Ministry of Health Labour and Welfare. Takeda also entered into an agreement with IDT Biologika GmbH (IDT) to utilize capacity for three months at IDT previously reserved for Takeda’s dengue vaccine candidate, to manufacture the single-shot COVID-19 vaccine developed by Janssen, the Pharmaceutical Companies of Johnson & Johnson. The three-month period is now complete. Takeda supports our partners and alliances in a shared goal to rapidly discover, develop and deliver effective treatments and vaccines for COVID-19 and ensure preparedness for future pandemics.
    • Hyperimmune globulin: Takeda co-founded the CoVIg-19 Plasma Alliance and joined forces with other leading plasma companies to evaluate a hyperimmune globulin medicine in a global clinical trial. While the data did not meet its endpoints, the program has contributed to the scientific understanding of antibody-based treatment to address the virus and highlighted the broader therapeutic value and importance of plasma to treat rare diseases.
    • Additional therapeutics: The company has assessed existing Takeda products for activity against the COVID-19 virus and co-founded the COVID R&D Alliance. In addition, Takeda has joined the Innovative Medicines Initiative (IMI) CARE consortium, the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership and the COVID RED project.

    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, Zika and norovirus. 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 (TSE: 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 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 and regions. For more information, visit http://www.asiamerlion.cn.


    Media Contacts:
    Japanese Media
    Ryoko Matsumoto
    ryoko.matsumoto@takeda.com
    +81 (0) 3-3278-3414

    Media Outside Japan
    Catherine Wilson
    catherine.wilson@takeda.com
    +1 440-488-6242

    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: http://www.asiamerlion.cn/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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