FY2022 Q3 Financial and R&D Update
Other Initiatives in Each Region
JPN
Europe/
ASCA
Anticancer agent EZHARMIAⓇ launched in Dec. 2022
➤ Indication: Relapsed or refractory adult T-cell leukemia-lymphoma (ATLL)
➤ MOA: Dual EZH1 and EZH2* inhibitor
➤ Administration: Usually, dosage for adult is 200 mg of valemetostat orally
administered once daily on an empty stomach. The dose should be reduced
as appropriate according to the patient's condition
*Histone methyltransferase involved in hematological cancer progression
0
·抗限性場剂 EZHI/2關書
「エザルミア錠50mg
バレメトスタットトシル
->
50mg
抗燃性寫潮 EZHI/2黑
Daiichi-Sankyo
10錠
10%
バレメトスタットトシル酸塩錠
「エザルミア錠100mg
100mg
EZHARMIAⓇ Tablet 50mg, 100mg
Agreement with Kite Pharma, Inc.: MA Transfer of Human Cell Therapy Product YESCARTAⓇ
R
➤ Objective: Expansion of access to YESCARTA ® therapy
➤ Transfer to: Gilead Sciences, K.K. (an affiliate of Kite Pharma, Inc.)
Timing: In CY 2023
➤Financials: DS to receive a royalty on product sales and a sales milestone payment
CLEAR Outcomes trial of lipid-lowering treatment NILEMDOⓇ met the primary study endpoint. The trial has
been designed to evaluate if bempedoic acid reduces CV events in high- and very high-risk patients who
tolerate no or very low doses of statin (Jan. 2023)
CLEAR Outcomes study
➤ event-driven, randomized, multicenter, double-blind, placebo-controlled Ph3 study led by Esperion Therapeutics, Inc.
The primary endpoint was relative risk reduction in major adverse cardiovascular events (MACE-4*)
➤ Comprehensive data will be presented at a key medical congress
*
Composite of the time to first cardiovascular death, nonfatal myocardial infarction, non-fatal stroke, or coronary revascularization
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