Investor Presentaiton
| Strong Pipeline Progression Since FY22 Q2
Takeda
Fm
MM
ASSET
VACCINES
QDENGA
TAK-003
ONCOLOGY
ICLUSIG
ponatinib
RARE GENETICS
& HEMATOLOGY
TAK-755
LIVTENCITY
maribavir
MILESTONE
Approved in EU and Indonesia, and positive
CHMP opinion for dengue-endemic countries
that participated in EMA EU-M4all procedure
1L Ph+ ALL positive phase 3 PhALLCON trial
Phase 3 trial interim analysis in cTTP:
Favorable efficacy and safety profile versus
standard of care
1L CMV infection in HSCT² phase 3 AURORA
trial confirmed favorable safety and showed
evidence of durable anti-viral efficacy
NEXT STEPS
Launch in Indonesia, Europe
Seek additional approvals: US and endemic countries
Data from this trial will be discussed with regulatory
agencies and shared with the scientific community
U.S. filing expected in FY22
CTTP: 2 case reports published in NEJM¹
Engaging regulatory agencies about filing strategy
12wk./16wk./20wk. data favorable for LIVTENCITY
•
•
Favorable safety profile with lower incidence of neutropenia
Did not achieve non-inferiority at 8 wk. 1' endpoint
Phase 3 start expected in FY22
GASTRO-
ENTEROLOGY
fazirsiran
TAK-999
AATD-LD positive phase 2b SEQUOIA trial
✓
NEURO-
SCIENCE
TAK-861
Met prespecified criteria to advance to
Phase 2
1.
2.
8
N Engl J Med 2022; 387:2356-2361, N Engl J Med 2022; 387:2391-2392
HSCT: hematopoietic stem cell transplantation; Press release: www.takeda.com/newsroom/newsreleases
For full glossary of abbreviations please refer to appendix.
Phase 2b on-track to start in January 2023View entire presentation