Edison Pharmaceuticals, Inc. enters into strategic alliance with Dainippon Sumitomo Pharma Co., Ltd.

  Edison Pharmaceuticals, Inc. enters into strategic alliance with Dainippon
                          Sumitomo Pharma Co., Ltd.

Novel partnership in drugs targeting biological energy

PR Newswire

MOUNTAIN VIEW, Calif., Jan. 31, 2014

MOUNTAIN VIEW, Calif., Jan. 31, 2014 /PRNewswire/ --Edison Pharmaceuticals
today announced that it has entered into a strategic alliance valued up to
$4.295 billion withDainippon Sumitomo Pharma Co., Ltd. (DSP) for the
development of drugs targeting cellular energy metabolism. Under the terms of
the 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 IND filing and broaden
its rights to EPI-589, 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.

Building on the March 2013 Edison/DSP collaboration agreement, the primary
clinical focus of the partnership is the adult central nervous system. Under
the terms of the expanded alliance agreement, DSP will gain access to three
jointly discovered compounds and fully fund their development in Japan and
North America. Edison will retain rights to these compounds outside of Japan
and North America. Edison will have worldwide rights to up to seven jointly
discovered compounds, which DSP will fund through IND filing. In addition, DSP
will broaden its rights to EPI-589 to include North America. Edison will
retain 100% ownership of its drug EPI-743, and it will continue to direct all
research, clinical development, and commercial development outside of Japan.

The research and development program is directed at the characterization of
the redox control energy system critical to the generation and regulation of
cellular energy metabolism. The parties believe that the cellular redox
"network" is an untapped reservoir of new drug targets, especially for high
energy-consuming organs such as the brain. DSP and Edison will work together
under a novel collaborative framework to discover, characterize, and translate
drugs into clinical development.

"The broadening of our partnership with Edison reflects the success we have
had to date in our current collaborative development programs. Compelling data
suggest that the mitochondria and redox regulation play a central role in a
variety of disease mechanisms," stated Hiroshi Noguchi, PhD, Chief Scientific
Officer and Member, Board of Directors of DSP. He further stated, "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 critical role in the regulation of energy
metabolism. Edison's initial clinical focus is on a set of pediatric diseases
where there are unambiguous genetic alterations in mitochondrial proteins
responsible for energy generation and regulation. These rare (orphan) diseases
are collectively referred to as inherited respiratory chain diseases of the
mitochondria. They form the basis of Edison's initial drug development
efforts; the breadth of Edison's proprietary technology platform extends well
beyond these conditions.

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. For
example, in the case of Parkinson's disease, 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.

"Our partnership with DSP codifies a common vision for developing drugs
targeting unmet medical needs. We will be able to grow and explore a frontier
of science through a collaborative and iterative learning process," stated Guy
Miller, MD, PhD, Chairman, CEO, Edison Pharmaceuticals, Inc. "Resources
committed by DSP to the partnership will accelerate our first-mover advantage
in redox drug development. This will allow us together to expand Edison's
pipeline, bringing 10 new compounds into clinical development over the next
five years. In addition, the DSP investment will allow Edison to build its
commercial enterprise in pediatric medicines. This will start with EPI-743,
Edison's drug candidate currently in phase 2 development for a variety of
inherited rare (orphan) pediatric mitochondrial diseases."

Edison Pharmaceuticals received financial advisory services on the transaction
from J.P. Morgan Securities LLC and Barclays, and legal counsel from Morrison
& Foerster, LLP.

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 about 7,000 employees
worldwide.Additional information about DSP is available through its corporate
website at www.ds-pharma.com.

SOURCE Edison Pharmaceuticals, Inc.

Website: http://www.edisonpharma.com
Contact: Edison Pharmaceuticals, Inc., 350 North Bernardo Avenue, Mountain
View, CA 94043, info@edisonpharma.com, edisonpharma.com
 
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