EDISON PHARMACEUTICALS INC DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News, GMP

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2 FDA Orange Book

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About

Edison is a world leader in the discovery and development of redox drugs. The company has obtained orphan designation in both the United States and Europe for its first drug candidate, EPI-743 (Vincerinone®). Vincerinone® is now in phase 2 clinical development. It is being evaluated in multiple clinical indications where defects in the mitochondrial proteins and redox control have been well characterized. Research Efforts Edison Pharmaceuticals’ research efforts are focused on the science of cellular energy and the development of drugs targeting the control of metabolism. Our first clinical indications are a group of diseases collectively known as “mitochondrial disease.” These diseases are frequently inherited and primarily affect children. They commonly result in severe neurological impairment and death. At present, there are no FDA- or EMA-approved treatments. Mitochondrial diseases share a common feature: defects in DNA that encode for proteins critical to the proper handling of electrons. The process of regulating the flow of electrons is known as redox control, and it is essential to the generation and regulation of energy. Thus, mitochondrial diseases are diseases of redox control. Company Strategy The Company’s strategy is to first gain approval for EPI-743 for orphan mitochondrial disease. It is already applying what it has learned from the study of these diseases to developing potential treatments for other neurological diseases with shared (redox) disease mechanisms.