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Mar. 29, 2013Print(PDF/31KB)Licensing

Dainippon Sumitomo Pharma signs a License Agreement with Edison Pharmaceuticals for therapeutic agents for mitochondria disease

Osaka, Japan, March 29 2013 - Dainippon Sumitomo Pharma Co., Ltd (DSP) (Headquarters: Osaka, Japan; President: Masayo Tada) announces today that it has signed at night, March 28, a research, development and commercial license agreement for the territory of Japan with Edison Pharmaceuticals, Inc (Edison) (Headquarters: Mountain View, California, U.S.) 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 US $35 million in an upfront payment and US $15 million as an R&D support fee for the development of EPI-589. In addition, Edison will receive US $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 US $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 U.S. 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.

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About Mitochondrial diseases
Mitochondria are organelles with functions such as producing energy for cells. Mitochondrial diseases are collectively referred to as diseases caused by mitochondrial dysfunction. Although a variety of symptoms appear, functions that require a lot of energy such as nerves, muscles, the heart, etc. are seen most often and various diseases are classified by their symptoms. Mitochondrial diseases are designated as intractable in government research projects.
About Leigh syndrome
Leigh syndrome is a type of mitochondrial disease that develops in early childhood with symptoms such as psychomotor retardation, muscle weakness, cramps and loss of muscle tone. It is thought that it may be caused by gene mutations and is considered one of the most serious mitochondrial diseases.
About Edison Pharmaceuticals
Edison Pharmaceuticals (Chairman and CEO: Guy Miller, MD, PhD) is a biotechnology company based on the discovery and development of low-molecular therapeutic drugs for the treatment of mitochondrial disease. Founded in 2006, it is headquartered in Mountain View, California, USA.