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Takeda Dengue Vaccine Candidate Meets Primary Endpoint in Phase 3 Pivotal Efficacy Trial

Thursday, Jan 31, 2019

Takeda Pharmaceutical Company Limited today announced that the pivotal Phase 3 trial of its candidate vaccine against dengue had met its primary efficacy endpoint. This first analysis of the Tetravalent Immunization Against Dengue Efficacy Study (TIDES) Tetravalent Efficacy Studyshowed that the company's live attenuated tetravalent experimental dengue vaccine (TAK-003) was effective in preventing dengue fever caused by any of the four serotypes of the virus. While extensive data is being reviewed, it was found that TAK-003 was well tolerated without raising any major safety concerns to date. TIDES The trial continues and further results are expected later in the year, and the results of other Phase 3 studies

"We are strongly encouraged by the performance of our dengue vaccine candidate in this study. This milestone brings us closer to the day when we can help the world tackle the enormous burden of dengue fever, "said Rajeev Venkayya, MD, president of Takeda's Global Vaccine Business Unit. "We are looking forward to publishing the data as soon as possible in a peer-reviewed journal. At the same time, we are making progress in clinical development, commercial manufacturing and stakeholder consultations to support a potential global launch of the vaccine in the future. "

The TIDES trial, Takeda's largest interventional clinical trial to date, has enrolled more than 20,000 healthy children and adolescents aged four to 16 who live in areas where dengue fever is endemic. The purpose of this study was to evaluate the efficacy, safety, and immunogenicity of two doses of TAK-003, both in dengue subjects and in people who had never been infected with this disease.

At present, TAK-003 is not licensed anywhere in the world. In addition to dengue, Takeda is developing vaccines for other high priority infectious diseases, including Zika virus disease, norovirus and polio diseases.

About the Phase 3 TENS Trial (DEN-301)
The Phase 3, double-blind, randomized, placebo-controlled TIDES trial aims to evaluate the safety and efficacy of two doses of TAK-003 in the prevention of laboratory-confirmed symptomatic dengue fever - regardless of severity - and due to one of the four serotypes of the dengue fever virus in children and adolescents. Participants were randomly selected to receive either TAK-003, 0.5 ml or placebo, by subcutaneous injection, on Day 1 and Day 90. 1 The study consists of three parts. Part 1, the current analysis, evaluated vaccine efficacy (EV) and safety for 15 months after the first dose. Part 2 continues for an additional six months to complete the evaluation of the secondary endpoints of EV, serotype, serology at baseline, and severity. Part 3 assesses EV and long-term safety by following participants for another three years.Data from Part 1 and Part 2 will form the basis of the application for registration.

The trial is being conducted in sites in dengue endemic areas, in Latin America (Brazil, Colombia, Panama, Dominican Republic and Nicaragua) and Asia (Philippines, Thailand and Sri Lanka), which show unmet need. dengue prevention and where severe forms of dengue fever are a leading cause of serious illness and death among children. Baseline blood samples were collected from all participants in the trial to assess safety and efficacy based on serologic status. Takeda and a Data Monitoring Committee composed of independent experts actively monitor safety on an ongoing basis.

About TAK-003
Takeda's tetravalent dengue vaccine (TAK-003) is based on a live attenuated serotype 2 dengue virus, which serves as a fundamental genetic element for all four vaccine viruses . 2 Phase 1 and Phase 2 data from children and adolescents showed that TAK-003 induced immune responses against all four serotypes of dengue, both in HIV-positive and seronegative participants, and it appeared that the vaccine is generally safe and well tolerated.

About Dengue
Dengue is the fastest growing mosquito-borne viral disease and the World Health Organization has declared it to be one of the top 10 global health threats in 2019. Dengue fever is transmitted by the Aedes aegypti and Aedes albopictus mosquitoes , and is caused by one of four dengue virus serotypes, each of which may cause dengue fever or severe dengue fever. The prevalence of individual serotypes varies by geographic area, country, region, season and over time.Healing following a serotype infection provides lifetime immunity only against the serotype, and subsequent exposure to one of the other serotypes is associated with an increased risk of serious disease.

Dengue epidemics are occurring in the tropics and subtropics, and epidemics have recently occurred in parts of the continental United States and Europe. About half of the world's population today lives under the threat of dengue fever, which is estimated to cause 400 million infections and 20,000 deaths each year worldwide.The dengue virus can infect people of all ages, and is a leading cause of serious illness in children in some Latin American and Asian countries.

Takeda's Commitment to Vaccines
Vaccines prevent more than two million deaths each year and have transformed global public health. 16For 70 years, Takeda has been providing vaccines to protect the health of the people of Japan. Today, Takeda's global vaccine business is innovative in addressing some of the world's most challenging infectious diseases, such as dengue fever, Zika virus disease, diseases caused by noroviruses and polio. Our team leverages its outstanding expertise and extensive knowledge in the development and manufacture of vaccines, and provides global access to boost vaccines under development to address a few vaccines. the most urgent public health needs in the world. To find out more, .

About Takeda Pharmaceutical Company Ltd.
Takeda Pharmaceutical Company Limited is a global, R & D, value-based, global biopharmaceutical leader, based in Japan, whose mission is to provide better health and a better future for patients by translating science into medicine very innovative. Takeda focuses its R & D efforts on four therapeutic areas: oncology, gastroenterology (GI), neuroscience and rare diseases. We also carry out targeted R & D investments in vaccines and plasma-derived therapies. We are specialized in developing highly innovative medicines that help make a difference in people's lives; for that, We are pushing the boundaries of new processing options and leveraging our collaborative R & D capabilities and engine optimized to create a robust and diverse pipeline. Takeda employees are committed to improving the quality of life for patients and collaborating with health care partners in approximately 80 countries and regions.

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