Takeda(US:TAK)2021-04-20 18:42Pipeline Highlights - Takeda anticipates up to 6 New Molecular Entity (NME) regulatory submissions by the end of FY21, with the potential for 4 approvals[8] - Takeda expects 7 NMEs in pivotal studies across 10 indications by the end of FY21[8] - Takeda intends to increase R&D investment to 500-550 billion JPY in FY2021[8] - Takeda has 11 Wave 1 NMEs, with 5 programs having Breakthrough Therapy Designation (BTD), 3 with Fast Track Designation (FTD), and 1 with Sakigake designation[17] Maribavir (TAK-620) - Maribavir demonstrated superior viremia clearance compared to conventional therapies, with a treatment difference of 328% at Week 8 in the Phase 3 Resistant/Refractory CMV Infection Study[58] - Maribavir maintained superior viremia clearance and symptom control through Week 16, with a treatment difference of 95%[61] - Approximately 25% of transplant patients experience Cytomegalovirus (CMV) infections[74] Soticlestat (TAK-935) - In the ELEKTRA study, the combined Dravet Syndrome (DS) & Lennox-Gastaut Syndrome (LGS) populations achieved a statistically significant placebo-adjusted seizure reduction of -305% over the 12-week maintenance period[129] - The Dravet Syndrome cohort in the ELEKTRA study showed a statistically significant placebo-adjusted median seizure reduction of 46%[135] - Approximately 10,000 patients are diagnosed with Dravet Syndrome in the US and approximately 30,000-50,000 patients are diagnosed with Lennox-Gastaut Syndrome in the US[150] Orexin Franchise (TAK-994) - Takeda is on track for potential first approval of an Oral Orexin Agonist in Narcolepsy Type 1 (NT1) in FY2024[161] - In sleep deprived healthy volunteers, TAK-994 demonstrated statistically significant improvements in the objective (MWT) and subjective (KSS) measures of wakefulness[203] - Approximately 30-50% of adult NT1 patients are estimated to be diagnosed in developed countries[224]