Edison, DSP announce R&D agreement

MOUNTAIN VIEW, Calif.—Edison Pharmaceuticals and DainipponSumitomo Pharma co., Ltd. (DSP) have established a new research/development andcommercialization agreement focused on EPI-743 and EPI-589 in Japan.

Per the terms of the agreement, DSP will pay Edison $35million up front and $15 million in research and development support, for whichit will gain development and commercialization rights in Japan. Edison willalso be eligible to receive between $10 million to $35 million in developmentmilestones per indication, as well as up to $460 million in commercialmilestone payments and royalties on commercial sales.

Initially, this agreement includes both pediatric orphaninherited mitochondrial and adult central nervous system disease indicationsfor the drugs. DSP will be responsible for undertaking the necessary activitiesfor development, approval and commercialization of EPI-743 in Japan, with thework focusing originally on orphan pediatric mitochondrial disease. DSP andEdison will collaborate on the research and development of EPI-589 with a focuson adult central nervous system disease. Edison will retain full ownership anddirect all research, clinical and commercial development of both compoundsoutside of Japan.

"Our partnership with Dainippon Sumitomo Pharma will allowEdison to accelerate the development and approval of the first drug forinherited respiratory chain diseases of the mitochondria," Guy Miller, M.D.,Ph.D., chairman and CEO of Edison, said in a press release regarding the deal. "Ourshared vision of the role of redox control and the mitochondria in humandisease will help us extend our learnings derived from rare pediatric diseasesto poorly treated acute and chronic adult CNS diseases."

EPI-743 is an orally bioavailable small molecule in thepara-benzoquinone drug class, and is currently under development by Edison forinherited mitochondrial diseases. EPI-589 is a next-generation, reversibleredox cofactor being developed to treat a variety of adult diseases. EPI-743 iscurrently in Phase II clinical development for the treatment of inheritedrespiratory chain disorders, with double-blind, placebo-controlled trialsunderway for the following indications: Leigh syndrome, Friedreich's ataxia,Cobalamin C defect and undiagnosed disorders of oxidation-reduction. Theproceeds from this partnership will be used to advance the late-stagedevelopment and commercialization of the compound for Leigh syndrome andFriedreich's ataxia, and for the advancement of EPI-743 in other exploratory PhaseII trials in the field of mitochondrial diseases.

Edison's translational technology platform is based on redoxbiochemistry. Redox chemistry is the basis of how cells make and regulateenergy metabolism, "the physical chemistry and biochemistry of reversibleelectron transfer reactions," Edison notes on its website. Edison translatesdiscoveries related to genetically confirmed, rare pediatric mitochondrialdiseases to adult central nervous system disorders, in which redox andmitochondrial dysfunction are also significant issues.

SOURCE: Edison press release