Otsuka has acquired rights from Eisai to develop and sell the DNA methylation inhibitor Dacogen® in the U.S., Canada, and Japan. Additionally, the company acquired licensing rights worldwide, excluding Mexico.
The drug is an intravenous formulation of decitabine 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), according to Otsuka.
The company also acquired from Eisai patent rights to an enzyme inhibitor 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, which it acquired in September 2013 for $866 million, concurrent with advancing clinical development of ASTX727 with the aim to provide an alternative, early-stage option in the treatment of MDS.
Dacogen was developed by SuperGen, now Astex Pharmaceuticals. MGI Pharma, acquired by Eisai in 2008, acquired worldwide rights to develop and market Dacogen from SuperGen and sublicensed worldwide rights (except for the U.S., Canada, Japan, and Mexico) to Janssen Pharmaceutical.
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). Janssen is responsible for R&D and commercialization of Dacogen in the EU where it is approved for AML.