01 Apr 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Dainippon Sumitomo Pharma (DSP) has signed a research, development and commercial license agreement for the territory of Japan with Edison Pharmaceuticals for EPI-743 and EPI-589, therapeutic agents under development by Edison for mitochondrial disease.
Under the terms of the agreement, DSP obtains exclusive research, development and commercial rights in Japan for EPI-743 and EPI-589. Edison will receive $35 million in an upfront payment and $15 million as an R&D support fee for the development of EPI-589. In addition, Edison will receive $10-35 million in milestone payments per indication associated with successful development. After launch, Edison will receive royalties based on sales amounts and up to $460 million in milestone payments in
accordance with sales goals. There is no change to DSP's earnings forecast for the fiscal year ending March 31, 2013.
EPI-743's mode of action is to synchronize energy generation in the mitochondria with the counterbalancing of redox stress. Edison is currently conducting a Phase 2B clinical trial of EPI-743 in the US and Europe
for Leigh syndrome- a mitochondrial disease which currently has no treatments. EPI-743 is expected to be a world first treatment for mitochondrial diseases beginning with Leigh syndrome.
EPI-589 is a next-generation redox cofactor modeled after EPI-743. Edison is conducting pre-clinical studies on EPI-589 and intends to advance its development for neuropsychiatric indications that share as a common etiology disorders of redox biochemistry.
DSP promotes the development of EPI-743 aiming to provide clinically meaningful treatment as soon as possible for patients in Japan with Leigh syndrome, a rare and lethal disease, with no effective treatments. In addition, by promoting the development of EPI-743 and EPI-589 for mitochondrial diseases and neuropsychiatric disorders, DSP hopes to contribute to the treatment of patients suffering from these diseases.