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Edison Pharmaceuticals, Inc. signs licensing agreement with Dainippon Sumitomo Pharma Co., Ltd. for development &

Edison Pharmaceuticals, Inc. signs licensing agreement with Dainippon Sumitomo
 Pharma Co., Ltd. for development & commercialization of orphan mitochondrial
                and adult central nervous system disease drugs

PR Newswire

MOUNTAIN VIEW, Calif., March 28, 2013

MOUNTAIN VIEW, Calif., March 28, 2013 /PRNewswire/ --Edison Pharmaceuticals
today announced that it has entered into a research/development and
commercialization agreementwithDainippon 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 bothpediatric orphan inherited
mitochondrial andadult 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 willinitially
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 withDainippon 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 reportedin 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
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

SOURCE Edison Pharmaceuticals, Inc.