MOUNTAIN VIEW, Calif., March 28, 2013 /PRNewswire/ -- Edison Pharmaceuticals today announced that it has entered into a research/development and commercialization agreement with Dainippon Sumitomo Pharma Co., Ltd. (DSP) for the development of EPI-743 and EPI-589 in Japan. Under the terms of the agreement, DSP will gain development and commercialization rights in Japan in exchange for Edison receiving $35 million in upfront and $15 million in R&D support. In addition, Edison will be eligible to receive $10-35 million in development milestones per indication and up to $460M in commercial milestone payments as well as royalties on commercial sales.
The initial scope of the transaction includes both pediatric orphan inherited mitochondrial and adult central nervous system diseases. Under the terms of the agreement, DSP will undertake activities required for development, approval, and commercialization of EPI-743 in Japan. The work will initially focus on orphan pediatric mitochondrial disease. Edison will retain 100% ownership and direct all research, clinical, and commercial development of EPI-743 and EPI-589 outside of Japan.
In addition, the parties will collaborate on the research and development of EPI-589 with a focus on adult central nervous system disease. This collaboration is based upon the emerging body of data implicating redox and mitochondrial dysfunction as a root cause of neurologic disorders.
Edison's translational platform is based on redox biochemistry. It bridges key learnings derived from genetically confirmed pediatric rare mitochondrial disease to adult central nervous system disorders where redox and mitochondrial dysfunction are likely to also play a critical role.
The Edison redox platform consists of proprietary laboratory and clinical tools that enable the discovery, optimization, and clinical validation of redox-directed drugs. Specifically, through employing both laboratory and clinically derived redox signatures of disease and drug action, Edison is able to develop drugs at a fraction of the time and cost of current drug development processes, thereby reducing risk and cost and increasing the likelihood of success.
Edison will use proceeds derived from the partnership to advance the late stage development and commercialization of EPI-743 for Leigh syndrome and Friedreich's ataxia, as well as to advance EPI-743 in other exploratory phase 2 trials for rare pediatric diseases with shared mitochondrial mechanisms.
"Our partnership with Dainippon Sumitomo Pharma will allow Edison to accelerate the development and approval of the first drug for inherited respiratory chain diseases of the mitochondria," stated Guy Miller, MD, PhD, Chairman and CEO of Edison. "Our shared vision of the role of redox control and the mitochondria in human disease will help us extend our learnings derived from rare pediatric diseases to poorly treated acute and chronic adult CNS diseases."
EPI-743 & EPI-589
EPI-743 is an orally bioavailable small molecule being developed by Edison Pharmaceuticals for the treatment of inherited mitochondrial diseases. EPI-743 is a member of the para-benzoquinone class of drugs. It serves as a cofactor for the novel drug target– NADPH quinone oxidase 1 (NQO1). Through a redox-based mechanism, EPI-743 augments endogenous glutathione biosynthesis– essential for the control of oxidative stress. EPI-589 is a next-generation, reversible redox cofactor being developed for a variety of adult diseases.
The positive clinical results of a phase 2A trial of EPI-743 in children with Leigh syndrome were recently reported in Molecular Genetics and Metabolism (EPI-743 reverses the progression of the pediatric mitochondrial disease—Genetically defined Leigh Syndrome 107 (2012) 383-388). Separate manuscripts detailing EPI-743 treatment effect on CNS and systemic glutathione biomarker levels are also reported in Molecular Genetics and Metabolism (Brain uptake of Tc99m-HMPAO correlates with clinical response to the novel redox modulating agent EPI-743 in patients with mitochondrial disease 107 (2012) 690-699; Glutathione: A redox signature in monitoring EPI-743 therapy in children with mitochondrial encephalomyopathies (2013), in press).
Edison Pharmaceuticals is a specialty pharmaceutical company dedicated to developing treatments for children and adults with orphan mitochondrial diseases. EPI-743 is in phase 2 clinical development for the treatment of inherited respiratory chain disorders. Double-blind placebo-controlled trials are ongoing for the following indications: Leigh syndrome, Friedreich's ataxia, Cobalamin C defect, and Undiagnosed Disorders of Oxidation-Reduction.
Dainippon Sumitomo Pharma Co., Ltd.
Dainippon Sumitomo Pharma Co., Ltd. (DSP) is a multi-billion dollar, top-ten listed pharmaceutical company in Japan with a diverse portfolio of pharmaceutical products. DSP aims to produce innovative pharmaceutical products in the psychiatry and neurology, which is designated as a key therapeutic area, as well as oncology. DSP has more than 7,000 employees worldwide. Additional information about DSP is available through its corporate website at www.ds-pharma.com.
SOURCE Edison Pharmaceuticals, Inc.