- Otsuka has acquired rights from Eisai Inc. to develop and sell in the US, Canada and Japan the DNA methylation inhibitor Dacogen®. In addition, Otsuka has acquired licensing rights worldwide, excluding Mexico. The drug is an intravenous formulation of decitabine (generic name) used in the treatment of myelodysplastic syndrome (MDS), in which ineffective or abnormal production of the myeloid class of blood cells occurs, and in the treatment of acute myeloid leukemia (AML).
- Otsuka also acquired from Eisai Inc. patent rights to E7727, which together with decitabine forms an oral combination compound in pre-clinical development, ASTX727.
- Otsuka will continue their existing decitabine-related business through Astex Pharmaceuticals, a U.S. subsidiary, concurrent with advancing clinical development of ASTX727 with the aim to provide an alternative, early-stage option in the treatment of MDS.
(Tokyo, Japan, March 31, 2014) – Otsuka Pharmaceutical Co., Ltd. (Otsuka) has announced an agreement with Eisai Inc. (Eisai), a U.S. subsidiary of Eisai Co., Ltd. to acquire rights to the hematological cancer treatment Dacogen® and to an enzyme inhibitor, E7727.
Rights Acquired From Eisai
1. Exclusive rights to the development and sale of DNA methylation inhibitor Dacogen®, an intravenous formulation of decitabine (generic name), in the U.S., Canada, and Japan in addition to the licensing rights worldwide excluding Mexico. Eisai will retain the rights in Mexico. Janssen Pharmaceutical Companies will retain its worldwide development and commercialization rights (excluding the U.S., Canada, Mexico and Japan).
2. Patent rights to metabolic enzyme inhibitor E7727, currently in pre-clinical development by Otsuka's U.S. subsidiary Astex Pharmaceuticals, Inc. E7727 is in development together with decitabine to form the combination product ASTX727 (an oral hypomethylating agent), which if approved would become the first oral formulation of decitabine.
Otsuka Pharmaceutical’s In-Line Products and Development Projects For Hematological Malignancies
Purpose and Significance of the Agreement
Otsuka's activities in the area of hematological malignancies began in March 2008 with the promotion of IV Busulfex®, a conditioning agent used prior to hematopoietic stem cell transplantation in patients with chronic myeloid leukemia. Since 2010, Otsuka has co-promoted Sprycel® in a joint venture with Bristol-Myers Squibb for treatment of patients in Japan, the U.S. and Europe with chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia.
Otsuka also has in phase II clinical trials a prodrug subcutaneous injection of decitabine, SGI-110. With Dacogen®, and potentially in the future with SGI-110 and ASTX727, Otsuka aims to further improve the quality of treatments available to patients with hematological malignancies.
Dacogen® was developed by SuperGen, Inc., (now Astex Pharmaceuticals, Inc.) as a therapeutic agent for myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) possessing cell differentiation-inducing activity through the inhibition of DNA methylation. U.S.-based MGI Pharma., (acquired by Eisai Inc. in 2008) acquired worldwide rights to develop and market Dacogen® from SuperGen, Inc. and sublicensed worldwide rights (except for the U.S., Canada and Mexico) to Janssen Pharmaceutical Companies. Dacogen® was approved for sale in the U.S. and is currently indicated for treatment for myelodysplactic syndromes (MDS) including previously treated and untreated de novo and secondary MDS of all FAB (French-American-British) hematological subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and for intermediate-1, imtermediate-2, and high-risk International Prognostic Scoring System groups.
Janssen is responsible for R&D and commercialization of Dacogen® in the EU (where it is approved for acute myeloid leukemia (AML)) and in other specified countries (where it is approved for AML and/or MDS).
Astex is a biotech company with a clinical research center in California in the U.S. and a drug discovery institute in Cambridge in the U.K. Astex was established in July 2011 upon the merger of the developer of Dacogen®, SuperGen, Inc., (U.S., founded 1991) and Astex Therapeutics Limited (U.K., founded 1999). Astex has evolved X-ray crystal structure analysis technology and established fragment-based drug discovery techniques that do not rely on conventional high-throughput screening (HTS), facilitating the creation of multiple compounds for the treatment of cancer and central nervous system disorders that are currently advancing through clinical development by leading pharmaceutical companies. Astex has been recognized internationally as a pioneer in fragment-based drug discovery. Astex became a subsidiary of Otsuka Pharmaceutical Co., Ltd., in October 2013.
Information in this news release was current as of the original release date.