Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Taiho Pharmaceutical Co., Ltd. announce that commercialization rights in the U.S. and Canada for anti-cancer drug candidates guadecitabine and ASTX727 will be transferred to Taiho Oncology, Inc. and Taiho Pharma Canada, Inc., respectively, from Astex Pharmaceuticals, an Otsuka subsidiary. Otsuka and Taiho are both part of the Otsuka group of companies.
Taiho Pharmaceutical presently markets its antineoplatic agent LONSURF® (trifluridine and tipiracil) in the U.S. and Canada, respectively, through subsidiaries Taiho Oncology and Taiho Pharma Canada. Astex will remain responsible for development of its two promising, late-stage-development candidates, guadecitabine and ASTX727.
Otsuka Pharmaceutical and Taiho Pharmaceutical aim to maximize their business impact and value by bringing together assets from across the Otsuka group of companies, including their respective strengths and experiences in the oncologic, psychiatric, neurologic, cardiovascular and renal fields.
Astex’s development-stage drug candidates for which North American commercialization rights will be transferred include:
|Guadecitabine||Acute myeloid leukemia（AML）||Phase 3|
|Myelodysplastic syndrome（MDS）||Phase 3|
|Ovarian cancer||Phase 2|
|A next-generation, low-molecular-weight DNA methylation inhibitor that is designed to allow the active metabolite decitabine to work longer in the body and thereby efficiently reach tissues such as the bone marrow. Therapeutic effects on patients with MDS and AML are hypothesized to occur through restoration of the function of inactivated tumor suppressor genes in cancer cells, thereby suppressing cancer formation and growth.|
|ASTX727||Myelodysplastic syndrome（MDS）||Phase 3|
|The first-ever, fixed-dose-combination, oral DNA methylation inhibitor that combines the metabolic enzyme inhibitor cedazuridine with decitabine, the active ingredient of the DNA methylation inhibitor Dacogen. Preliminary results of phase 3 trials in patients with MDS indicated that the plasma drug concentration-time curve (AUC) and pharmacodynamics, safety, and tolerability were equivalent to those of Dacogen injections.|