PRINCETON, N.J., June 7, 2019 – Taiho Oncology, Inc. announces that it has assumed commercialization responsibility from Otsuka Pharmaceuticals Co., Ltd., (Otsuka) for the novel fixed-dose combination of cedazuridine and decitabine (ASTX727) and guadecitabine (SGI-110) in the U.S. and Canada, subject to regulatory approvals. Taiho Pharma Canada, Inc., will commercialize these compounds in Canada.
The two candidates are in late-stage clinical development by Astex Pharmaceuticals, a wholly owned subsidiary of Otsuka. Taiho Oncology is also part of the Otsuka group of companies.
“This commercialization agreement is highly significant for Taiho Oncology as it allows us to build on the long-term strategy of expanding our presence in North America,” said Taiho Oncology, Inc. Chief Executive Officer Timothy Whitten. “These investigational therapies have the potential to provide physicians and patients with much-needed treatment options for a range of hematologic malignancies. We look forward to working with Astex as we bring these compounds to market.”
On June 6, 2019, Astex Pharmaceuticals and Otsuka announced top-line results from the Phase III ASCERTAIN study evaluating ASTX727 vs. decitabine IV in adults with intermediate and high-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML). The trial met its primary endpoint of decitabine area-under-the-curve (AUC) equivalence of total 5-day dosing between orally administered ASTX727 and IV decitabine. The full data will be presented at an upcoming scientific meeting.
Astex has current studies with guadecitabine (SGI-110) in relapsed and refractory acute myeloid leukemia (R/R AML) and relapsed and refractory myelodysplastic syndromes (R/R MDS) and CMML.
About Taiho Oncology, Inc. (U.S.)
Taiho Oncology, Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd. and an indirect subsidiary of Otsuka Holdings Co., Ltd., has established a world-class clinical development organization that works urgently to develop innovative cancer treatments and has built a commercial business in the U.S.
Taiho has an oral oncology pipeline consisting of both novel antimetabolic agents and selectively targeted agents. Advanced technology, dedicated researchers, and state of the art facilities are helping us to define the way the world treats cancer. It’s our work; it’s our passion; it’s our legacy.
For more information about Taiho Oncology, please visit: https://www.taihooncology.com.
For more information about Taiho Pharmaceutical Co., Ltd., please visit: https://www.taiho.co.jp/en/.
About Astex Pharmaceuticals, and Otsuka Pharmaceutical
Astex is a leader in innovative drug discovery and development, committed to the fight against cancer and diseases of the central nervous system. Astex is developing a proprietary pipeline of novel therapies and has multiple partnered products in development under collaborations with leading pharmaceutical companies. Astex became a wholly owned subsidiary of Otsuka in 2013.
Otsuka Pharmaceutical Co., Ltd., based in Tokyo, Japan, is a global healthcare company with the corporate philosophy: “Otsuka – people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.
For more information about Astex Pharmaceuticals, visit: http://www.astx.com.
For more information about Otsuka Pharmaceutical, visit: http://www.otsuka.com/en/.
Contacts for U.S. Media
On behalf of Taiho Oncology:
Chief Corporate Officer
Astex Pharmaceuticals, Inc.