Takeda Presents 18-Month Data from Pivotal Phase 3 Trial of Dengue Vaccine Candidate at the American Society of Tropical Medicine and Hygiene (ASTMH) 68th Annual Meeting

Takeda Pharmaceutical Company Limited (TSE:4502 / NYSE:TAK) (“Takeda”) today announced that updated results from the ongoing pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial of its dengue vaccine candidate (TAK-003) were presented at the American Society of Tropical Medicine and Hygiene (ASTMH) 68^th Annual Meeting. The data presented include an update on overall vaccine efficacy (VE) and a formal assessment of secondary efficacy endpoints by serotype, baseline serostatus and disease severity (18 months after the second dose, which was administered three months after the first dose). The TIDES trial met all secondary endpoints for which there were a sufficient number of cases. Overall vaccine efficacy and safety results from the second part of the study were generally consistent with the data reported in the primary endpoint analysis (overall VE was 73.3% [95% confidence interval (CI): 66.5% to 78.8%; p<0.001] in the 18-month analysis, and VE was 80.2% (95% CI: 73.3% to 85.3%) in the primary endpoint analysis [12 months after the second dose]). The primary endpoint analysis of overall VE was recently published in the New England Journal of Medicine,¹ demonstrating protection against virologically-confirmed dengue (VCD) in children ages four to 16 years, regardless of previous exposure to dengue.

Assessment of secondary endpoints showed that VE against hospitalized dengue was 90.4% (95% CI: 82.6% to 94.7%; p<0.001) and VE against dengue hemorrhagic fever was 85.9% (95% CI: 31.9% to 97.1%); efficacy against severe VCD could not be determined due to an insufficient number of cases (VE: 2.3% [95% CI: -977.5% to 91.1%). Overall efficacy was similar in baseline seropositive and seronegative individuals (VE: 76.1% [95% CI: 68.5% to 81.9%] vs. VE: 66.2% [95% CI: 49.1% to 77.5%], respectively). Efficacy results varied by individual serotype: VE was 69.8% for dengue serotype 1 (95% CI: 54.8% to 79.9%), 95.1% for dengue serotype 2 (95% CI: 89.9% to 97.6%), and 48.9% for dengue serotype 3 (95% CI: 27.2% to 64.1%). There were an insufficient number of dengue serotype 4 cases to adequately assess efficacy at this time (VE: 51.0% [95% CI: -69.4% to 85.8%]). Efficacy endpoints will continue to be assessed over the course of the trial.