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

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 https://www.takeda.com.