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Takeda Test Dengue Vaccine Hub Phase 3 Efficacy Test meets primary endpoint – Business Wire China



– The study found that the candidate vaccine was well tolerated and that no significant safety issues were identified in the analysis so far –

Cambridge, MA and Osaka, Japan – (BUSINESS WIRE) – Takeda Pharmaceutical Co., Ltd.[TSE:4502 / NYSE:TAK]("Wuta") today announced that its key phase 3 trial of a candidate for dengue vaccination has reached its primary endpoint of efficacy. A first analysis of tetanus dengue (TIDES) activity showed that active attenuated tetravalent dengue vaccine (TAK-003) was effective in preventing dengue fever caused by one of four dengue virus serotypes. Although the review of the entire dataset is still ongoing, TAK-003 is well tolerated and no major safety concerns have been observed yet. The TIDES test runs and other results are expected in connection with the results of the other three phases in the second half of this year.from

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This press release contains multimedia content. A full press release is available at: https://www.businesswire.com/news/home/20190129005286/en/

MUDr. Rajeev Venkayya, chairman of the Takeda Global Vaccine Business Unit, said: "We are encouraged by the execution of our dengue vaccine candidate in this study, helping us to help the world make the next step in the dengue burden." Yes, the information will be published as soon as possible in professional journals At the same time, we promote clinical development, commercial production and stakeholder consultation to support the possibility that the vaccine will be sold globally in the future. "

The TIDES study is the largest intervention clinical trial ever conducted by Takeda, with over 20,000 healthy children and adolescents living in areas prone to dengue aged 4 to 16 years. This study was designed to evaluate the efficacy, safety and immunogenicity of two doses of TAK-003 in exposed and unexposed dengue individuals.from

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TAK-003 has not yet been approved in any part of the world. In addition to dengue, Takeda develops vaccines that respond to other high-priority infectious diseases, including Zika, Norovirus and Polio.

O3PeriodTIDES (DEN-301)Test

The double-blind, randomized, placebo-controlled TIDES trial from Phase 3 evaluated the safety and efficacy of two doses of TAK-003 in the prevention of laboratory-confirmed symptomatic dengue due to any severity in children and adolescents and in all four serotypes of Dengue Sexfrom

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. Participants were randomized to subcutaneous injection of 0.5 ml of TAK-003 or placebo on days 1 and 90.from

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. The study is divided into three parts. The current analysis is part 1, which evaluates vaccine efficacy (VE) and safety 15 months after the first injection. Part 2 continued for 6 months in order to achieve a secondary endpoint assessment of VE endpoints based on serotype, baseline serum and severity. Part 3 has been monitored for 3 years in order to assess VE and long-term safetyfrom

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. The information set out in Parts 1 and 2 is the basis for the submission of the review.

Attempts were made in areas with daily illness including Latin America (Brazil, Colombia, Panama, Dominican Republic and Nicaragua) and Asia (Philippines, Thailand and Sri Lanka) where dengue prevention and serious dengue fever was not a major cause of serious illness and death in childrenfrom

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. Initial blood samples were taken from all study participants in order to assess safety and efficacy based on serum status. Takeda and the independent expert monitoring committee actively and continuously monitor security.

OTAK-003

The four-fold Takeda vaccine for dengue fever (TAK-003) is based on the active attenuated dengue serotype virus type 2, which provides the skeleton gene of all four vaccine viruses.from

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. Phase 1 and Phase 2 data from children and adolescents showed that TAK-003 induced an immune response against all four dengue serotypes in seropositive and seronegative subjects, and the vaccine was generally safe and well tolerated.from

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About the dengue fever

Daytime fever is the fastest growing viral disease caused by mosquitoes and one of the top ten global health threats identified by the World Health Organization in 2019.from

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. Dengue feverfrom

Aedes aegyptiANDfrom

Chimney of white lineDissemination caused by any of the four dengue virus serotypes, each of which can cause dengue fever or severe dengue feverfrom

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. The prevalence of each serotype varies by region, country, region, and time.from

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. Lifetime resistance to this serotype can be achieved by serotyping and recovery. Exposure to any of the other three serotypes may lead to an increased risk of severe dengue fever.from

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The outbreak of dengue fever occurs in tropical and subtropical areas and has recently exploded in the United States and parts of Europe.from

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. About half of the world's people live under the threat of dengue and it is estimated that 400 million people will be infected worldwide and 20,000 people die each year.from

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. Dengue virus can infect people of all ages and is the main cause of serious illness in children in Latin America and parts of Asia.from

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Takeda is a commitment to vaccines

This vaccine prevents more than 2 million deaths each year and has changed global public healthfrom

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. Over the past 70 years, Takeda has been providing Japanese health care vaccines. Today, Takeda, in the area of ​​global vaccines, is applying innovations that address some of the world's most challenging infectious diseases such as dengue, Zika, norovirus and polio. Our team provides excellent experience and extensive knowledge on the development, production and global availability of vaccines to manage the subsequent vaccine product line that meets some of the most urgent public health requirements in the world. For more information, visit www.TakedaVaccines.com.

About Takeda Pharmaceutical Co., Ltd.

Takeda Pharmaceutical Co., Ltd. (TSE: 4502) (NYSE: TAK) is a Japanese, transnational, biopharmaceutical leader based on R & D values ​​to transform science into highly innovative drugs, good health and a clearer future. Takeda's research efforts focus on four major therapeutic areas: oncology, gastroenterology (GI), neuroscience and rare diseases. We also invest in targeted research and development in the field of plasma drugs and vaccines. We are focusing on the development of highly innovative medicines that help improve patients' lives, strive to strengthen top-of-the-line treatment options, and use our improved research tools and research capabilities to develop strong and diverse aftercare models. Line. Our employees are committed to improving the quality of life of our patients and working with our healthcare partners in around 80 countries.

For more information, visit https://www.takeda.com.

Links

1. Efficacy, Safety, and Immunogenicity of Takeda's tetravalent dengue vaccine (TDV) in healthy children (TIDES) 2017. Obtained in August 2018. (TDV) in Healthy Children Tetra-Fever Effectiveness, Safety and Immunogenicity (TIDES) )

2. Huang, CY-H., Et al., Genetic and Phenotypic Characterization of Production Seeds for the Tetravalent Dengue Vaccine (DENVax), PLoS Neglected Tropical Diseases, 2013. Obtained August 2018. (Huang, CY-H et al. Genetic and Phenotypic Vaccine Characteristics (DENVax) for PLoS Seed Plants Neglected Tropical Disease 2013. Searched in August 2018)

3. Sáez-Llorens, X., Tricou, V. et al. Safety and immunogenicity of one to two doses of tetravalent dengue Takeda: Continuous results of long-term, randomized, placebo-controlled Phase 2 pediatric studies in Asia A Latin America. from

Lancet infectious diseases2017. Taken in August 2018. (Sáez-Llorens, X., Tricou, V. et al., Safety and immunogenicity of Takeda with 4-Day Day 1 Dose versus 2: long-term randomized placebo in children in Asia and Latin America Interim results of the controlled study , a lancet infectious disease supplement, 2017. Searched in August 2018)

4. Osorio, J. E. et al. The safety and immunogenicity of a recombinant live attenuated tetravalent dengue vaccine (DENVax) in healthy adult collagen-deficiency patients in Colombia: a randomized, placebo-controlled Phase 1 study. from

Lancet infectious diseases2014. Obtained in August 2018. (Osorio, JE et al.) Safety and immunogenicity of recombinant active attenuated tetravalent dengue vaccine (DENVax) in healthy adults not infected in Colombia Province: Randomized placebo-controlled Phase 1 study Appendix Lancet Infectious Disease , 2014. Searched in August 2018)

5. Wallace, D. The persistence of neutralizing antibodies one year after two doses of candidate recombinant tetravalent dengue vaccines in individuals aged 1.5 to 45, presented at the 6th Annual Meeting of the American Society for Tropical Medicine and Hygiene, 2015. (Wallace D. Neutralizing antibodies may persist for 1 year after administration of 1.5 doses of a recombinant tetravalent dengue vaccine candidate aged 1.5 to 45 years reported at the 6th Annual Meeting of the American Society for Tropical Medicine and Hygiene.

6. Saez-Llorens, X. et al., Phase II, a double-blind, controlled trial to assess the safety and immunogenicity of various Takeda Schedules for tetravalent Dengue Vaccine (TDV) in healthy subjects aged 2 to 18 years and (Saez- Llorens, X. et al., Phase II double-blind controlled trial to evaluate different candidates for dengue vaccine (TDV) in Takeda Treatment is safe and immunogenic in healthy individuals aged 2 to 18 years living in dengue fever countries in Asia and Latin America, reported in the 5th Pan American Journal of Dengue Research Network.

7. World Health Organization Fact sheet on vector diseases 2014. Retrieved August 2018. (World Health Organization, List of Facts About Insect Disease, 2014. Seeking in August 2018)

8. World Health Organization: Ten threats to global health in 2019. 2019. Obtained in January 2019. (World Health Organization, Ten World's Worst Threats to Global Health in 2019. 2019. Seeking in January 2019)

9. World Health Organization: Dengue and Heavy Dengue, 2016. Retrieved August 2018. (World Health Organization, Dengue Fever and Heavy Fever Dengue, 2016. Seeking in August 2018)

10. Centers for Disease Control and Prevention Clinical Guidelines Dengue Virus 2014. Retrieved August 2018. (Center for Disease Control and Prevention, Dengue Viral Virological Guidelines for 2014. Searched in August 2018)

11. Bravo, L., et al., Epidemiology of Dengue Disease in the Philippines (2000-2011): Systematic Literature. from

PLoS neglected tropical diseases(Bravo, L. et al., Epidemiology of Dengue Fever in the Philippines (2000-2011): Literature Review, PLoS Neglected Tropical Diseases, 2014. Searched in August 2018)

12. Guzman, M.G. et al. Dengue: Continuing Global Threat. from

Nature Reviews Microbiology2010. Acquired in August 2018. (Guzman, M.G. et al., Dengue Fever: Persistent Global Threat, Nature Review Microbiology, 2010. Searched in August 2018)

13. Knowlton, K., et al., Threat of Mosquito-Borne Dengue Fever in Northwestern America, NRDC, 2009. Obtained August 2018. (Knowlton, K. et al. NRDC, 2009. Searched in August 2018)

14. Chan E., et al. Using Day Search Query Data to Monitor Dengue Outbreak: A New Model to Stop Tropical Disease Monitoring. from

PLoS neglected tropical diseases2011. Caught in August 2018. (Chan E. et al., Application of Internet Search Queries for Dengue Epidemic Indicators: a New Model for Observing Neglected Tropical Diseases, PLoS Neglected Tropical Diseases August)

15. Murray N. E. et al., Dengue Epidemiology: past, present and future prospects. from

Clinical epidemiology(Murray, N.E. et al., Dengue Epidemiology: Past, Current and Future Prospects, Clinical Epidemiology, 2013. Seeked in August 2018)

16. UNICEF: Facts and figures on immunization in 2013. Obtained in August 2018. (UNICEF, facts and figures on vaccination, 2013. Seeking in August 2018)

The original version is available at businesswire.com: https://www.businesswire.com/news/home/20190129005286/en/

Disclaimer: The original version of this announcement is an officially licensed version. The translation is only for your convenience. Please read the original text, the original version is legally valid only.

Contact informations:

Japanese media

Kazumi Kobayashi
Kazumi.kobayashi@takeda.com
+81 3 3 278 2095

Media outside Japan

Amy Atwood
Amy.atwood@takeda.com
+ 1-617-444-2147

Candida Takeda dengue fever, a quantitative Phase 3 study, reached the primary endpoint (Photo: David Parnes Photography)

Candida Takeda dengue fever, a quantitative Phase 3 study, reached the primary endpoint (Photo: David Parnes Photography)


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