Edison Pharmaceuticals Enters Alliance with Dainippon Sumitomo Pharma

Edison Pharmaceuticals announced that it has entered into a strategic alliance valued at up to $4.295 billion with Dainippon Sumitomo Pharma (DSP) for the development of drugs targeting cellular energy metabolism. Building on an Edison and DSP collaboration agreement announced in March, 2013, the primary clinical focus is the adult central nervous system.

Under the terms of the expanded agreement, DSP will gain select development and commercialization rights in Japan and North America to jointly discovered drugs in exchange for $10M upfront and $40M payment in R&D support. In addition, DSP will fully fund the development of 10 new jointly discovered drugs through investigational-new-drug (IND) filing and broaden its rights to EPI-589 (a central nervous system treatment currently in phase 1B), to include North America. In exchange, Edison will be eligible to receive in total between $30M and $105M per indication associated with successful development of EPI-589 in North America; between $10M and $30M per indication in development milestones associated with successful development of jointly discovered compounds in Japan and North America; up to $3.86 billion in commercial milestone payments for jointly discovered compounds and EPI-589 in total; and double-digit royalties on commercial sales. DSP will also invest $50M in Edison through a preferred stock purchase agreement. At the discretion of Edison, DSP shall invest an additional $50M in the period between the first and fifth anniversaries of the initial equity closing. Edison will retain full ownership of its drug EPI-743 (an orally bioavailable small molecule for the treatment of inherited mitochondrial diseases), and it will continue to direct all research, clinical development, and commercial development outside of Japan.

The R&D program is directed at the characterization of the redox control energy system crucial to the generation and regulation of cellular energy metabolism. The cellular redox “network” is an untapped reservoir of new drug targets, especially for high energy-consuming organs such as the brain, said the companies. DSP and Edison will work together under a novel collaborative framework to discover, characterize, and translate drugs into clinical development.

“Compelling data suggest that the mitochondria and redox regulation play a central role in a variety of disease mechanisms,” said Hiroshi Noguchi, PhD, chief scientific officer and member of the board of directors of DSP, in the press release. “As Edison is a leader in redox drug development, we see the highly integrated alliance structure as a way to bring our companies closer together in order to leverage our mutual strengths, make new and important discoveries, and bring valuable new drugs to the marketplace for critical diseases with unmet medical need.”

The term redox refers to a set of chemical reactions involving the tandem accepting and donating of electrons. Redox biochemical and enzyme-catalyzed reactions underlie the vast majority of the chemistry responsible for the generation of energy within the cellular powerhouse, the mitochondrion. In addition, redox reactions play a crucial role in the regulation of energy metabolism. Edison’s initial clinical focus is on a set of pediatric diseases for which there are unambiguous genetic alterations in mitochondrial proteins responsible for energy generation and regulation. These rare (i.e., orphan) diseases are collectively referred to as inherited respiratory chain diseases of the mitochondria. Inherited pediatric mitochondrial disease and a variety of adult neurodegenerative diseases may arise through analogous genetic errors in mitochondrial proteins, giving rise to common biochemical consequences. In the case of Parkinson’s disease, for example, a variety of inherited forms of the disease are caused by defects in proteins associated with mitochondrial function. Additionally, both pediatric mitochondrial diseases and adult neurodegenerative diseases display a common biochemical signature of excess electrons. This is commonly referred to as oxidative stress. Edison is leveraging its core expertise in redox biochemistry and its proprietary technology platform to develop novel drugs targeting redox pathways common to pediatric mitochondrial disease and adult neurodegenerative diseases, as well as fundamental aging mechanisms.

Source: Edison Pharmaceuticals