Potential Impact of Takeda’s Dengue Vaccine Candidate Reinforced by
Long-Term Safety and Efficacy Results

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IO- Jakarta, May 28, 2021 – Takeda Pharmaceutical Company Limited (Takeda) announced that its dengue vaccine candidate (TAK-003) demonstrated continued protection against dengue illness and hospitalization, regardless of an individual’s previous dengue exposure, with no important safety risks identified through three years after vaccination in the ongoing pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial. TIDES enrolled more than 20,000 healthy children and adolescents ages four to 16 years in dengue-endemic countries in Latin America and Asia.

“Dengue epidemics occur suddenly, and hospitals can become overwhelmed with severe disease cases and people seeking testing,” said LakKumar Fernandoi, M.D., Center for Clinical Management of Dengue and Dengue Haemorrhagic Fever, Negombo General Hospital, Sri Lanka and a primary investigator of the TIDES trial. “Results from the long-term analysis of Takeda’s dengue vaccine candidate suggest that it could help with outbreak prevention, reduce rates of hospitalization and protect people from dengue regardless of their previous exposure. Importantly, no important safety risks were identified.”

Safety and efficacy results from the 36-month follow-up exploratory analysis of TIDES were presented on May 22, 2021, at the 17th Conference of the International Society of Travel Medicine (CISTM). Through three years (36 months after the second dose), TAK-003 demonstrated overall vaccine efficacy (VE) of 62.0% against virologically-confirmed dengue (VCD). TAK-003 also demonstrated 83.6% VE against hospitalized dengue. 

Observations of varied VE by serotype remained consistent with previously reported results. No evidence of disease enhancement was observed. TAK-003 was generally well tolerated, and there were no important safety risks observed. The results reinforce the potential of TAK-003 to help protect those who are living in or traveling to dengue-endemic countries.

“Our dengue vaccine candidate continued to provide protection against dengue throughout three years, and was especially robust in preventing hospitalization,” said Derek Wallace, VP, Dengue Global Program Leader at Takeda. “These results reinforce my confidence that TAK-003 can help address the significant global burden of dengue.”

As previously reported, the TIDES trial met its primary endpoint of overall VE against VCD at 12-months follow-up and all secondary endpoints for which there were a sufficient number of dengue cases (measured at 18-months follow-up). The TIDES trial has been amended to include the evaluation of a booster dose to address the waning of overall VE observed over time (from 12 through 36 months after the second dose), largely driven by outpatient dengue. Takeda intends to publish results of the 36-month exploratory analysis in a peer-reviewed journal this year.

TIDES safety and efficacy data through 36-months follow-up was included in regulatory submissions to the European Union and dengue-endemic countries and will be part of additional filings planned for 2021, including in the United States. 

 

Takeda will seek an indication for TAK-003 for the prevention of dengue disease in individuals four to 60 years of age, regardless of previous virus exposure, based on data in both adults and children. There remains a need for dengue vaccines that can be used in both dengue-naïve and dengue-exposed adults and children.

About Dengue

Dengue is the fastest spreading mosquito-borne viral disease and was one of the WHO’s top 10 threats to global health in 2019.6,7 Dengue is mainly spread by Aedes aegypti mosquitoes and, to a lesser extent, Aedes albopictus mosquitoes. It is caused by any of four dengue virus serotypes, each of which can cause dengue fever or severe dengue. The prevalence of individual serotypes varies across different geographies, countries, regions, seasons and over time.8 Recovery from infection by one serotype provides lifelong immunity against only that serotype, and later exposure to any of the remaining serotypes is associated with an increased risk of severe disease.

Dengue is pandemic prone, and outbreaks are observed in tropical and sub-tropical areas and have recently caused outbreaks in parts of the continental United States and Europe.9,10 Approximately half of the world now lives under the threat of dengue, which is estimated to cause 390 million infections and around 20,000 deaths globally each year.10,11 The dengue virus can infect people of all ages and is a leading cause of serious illness among children in some countries in Latin America and Asia.10

Takeda’s Commitment to Vaccines

Vaccines prevent 2 to 3 million deaths each year and have transformed global public health.12 For the past 70 years, Takeda has supplied vaccines to protect the health of people in Japan. Today, Takeda’s global vaccine business is applying innovation to tackle some of the world’s most challenging infectious diseases, such as dengue, COVID-19, Zika and norovirus. Takeda’s team brings an outstanding track record and a wealth of knowledge in vaccine development, manufacturing and global access to advance a pipeline of vaccines to address some of the world’s most pressing public health needs.

About Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) is a global, values-based, R&D-drivenbiopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transformingtreatments, guided by our commitment to patients, ourpeople and the planet. Takeda focuses its R&D effortson four therapeutic areas: Oncology, Rare Genetic andHematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing ondeveloping highly innovative medicines that contribute tomaking a difference in people’s lives by advancing thefrontier of new treatment options and leveraging ourenhanced collaborative R&D engine and capabilities tocreate a robust, modality-diverse pipeline. Our employees are committed to improving quality of life forpatients and to working with our partners in health carein approximately 80 countries. For more information, visit https://www.takeda.com.