TAKEDA-PHARMACEUTICAL

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK ) (“Takeda”) today announced the opening of its new manufacturing plant in Singen, Germany, for its dengue vaccine candidate, TAK-003. The Singen vaccine plant will be utilized for formulation, fill, finish and secondary packaging of the dengue vaccine candidate starting with the packaging line. Takeda invested more than 130 million Euro and will employ up to 200 employees in the vaccine plant.

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According to the World Health Organization (WHO), dengue is the fastest spreading mosquito-borne viral disease, which is estimated to cause approximately 390 million infections and 20,000 deaths globally each year.²

“This project is one of our most significant investments within our global manufacturing network. We are proud to open this new, state of the art sterile manufacturing plant, which combines a high degree of automation with the most advanced digital and data-driven technologies,” said Thomas Wozniewski, Global Manufacturing and Supply Officer. “Our Singen site has been selected for this investment as our employees have vast experience in lyophilization technology, which is key for the manufacturing process of Takeda’s dengue vaccine candidate.”

“This new production facility expands Takeda’s global footprint in vaccine manufacturing beyond Hikari, Japan and reinforces our capability to manufacture at scale and meet the global demand that we anticipate for this vaccine,” said Rajeev Venkayya, MD, President of the Global Vaccine Business Unit at Takeda.

Initial construction activities started at the end of 2016 and the plant is now ready to begin production for packaging, with the goal to launch end-to-end production closer to licensure.

Takeda’s dengue vaccine candidate is currently being investigated in the pivotal Phase 3, multi-centered, global, double blind, randomized, placebo-controlled trial to evaluate the efficacy, safety and immunogenicity of a tetravalent dengue vaccine administered subcutaneously in healthy children aged four to 16 years old. Takeda announced the trial met the primary efficacy endpoint in January 2019. The first interpretable results of the Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial showed that the investigational live-attenuated tetravalent dengue vaccine was efficacious in preventing dengue fever caused by any of the four serotypes of the virus. The TIDES trial is ongoing and additional results will be published later this year, along with results from other Phase 3 studies. Takeda’s dengue vaccine candidate is not currently licensed anywhere in the world.

About Takeda’s Dengue Vaccine Candidate (TAK-003)
Takeda's tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all four vaccine viruses.³ Clinical Phase 1 and 2 data in children and adolescents showed that TAK-003 induced immune responses against all four dengue serotypes, in both seropositive and seronegative participants, and the vaccine was found to be generally safe and well tolerated.^4,5,6,7

About Takeda’s Commitment to Vaccines
Vaccines prevent 2 to 3 million deaths each year and have transformed global public health.⁸ For the past 70 years, Takeda has supplied vaccines to protect the health of people in Japan. Today, Takeda’s global vaccine business is applying innovation to tackle some of the world’s most challenging infectious diseases, such as dengue, Zika and norovirus. Our team brings an outstanding track record and a wealth of knowledge in vaccine development, manufacturing and global access to advance a pipeline of vaccines to address some of the world’s most pressing public health needs. For more information, visit www.TakedaVaccines.com .

About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK ) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Gastroenterology (GI), Rare Diseases and Neuroscience. 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 .

References

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¹ ClinicalTrials.gov. Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children (TIDES) . 2017. Retrieved September 2019.
² World Health Organization. Dengue and Severe Dengue . 2019. Retrieved September 2019.
³ Huang, C. Y.-H., et al. Genetic and Phenotypic Characterization of Manufacturing Seeds for Tetravalent Dengue Vaccine (DENVax) . PLoS Neglected Tropical Diseases. 2013. Retrieved September 2019.
⁴ Sáez-Llorens, X., Tricou, V., et al. Safety and immunogenicity of one versus two doses of Takeda's tetravalent dengue vaccine: Interim results of a long-term phase 2, randomized, placebo-controlled pediatric trial in Asia and Latin America. The Lancet Infectious Diseases. 2017. Retrieved September 2019.
⁵ Osorio, J.E., et al. Safety and immunogenicity of a recombinant live attenuated tetravalent dengue vaccine (DENVax) in flavivirus-naive healthy adults in Colombia: a randomised, placebo-controlled, phase 1 study . The Lancet Infectious Diseases. 2014. Retrieved September 2019.
⁶ Wallace, D. Persistence of neutralizing antibodies one year after two doses of a candidate recombinant tetravalent dengue vaccine in subjects aged from 1.5 to 45 years. Presented at 6th Annual Meeting, American Society of Tropical Medicine and Hygiene. 2015.
⁷ Saez-Llorens, X., et al. Phase II, double-blind, controlled trial to assess the safety and immunogenicity of different schedules of Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) in healthy subjects aged between 2 and <18 years and living in dengue endemic countries in Asia and Latin America. Presented at 5th Pan-American Dengue Research Network Meeting. 2016.
⁸ World Health Organization. Immunization . 2019. Retrieved September 2019.

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