November 27, 2014 4:06 PM ET

Pharmaceuticals

Company Overview of Edison Pharmaceuticals, Inc.

Company Overview

Edison Pharmaceuticals, Inc. develops medicines for the treatment of inherited mitochondrial diseases. It offers EPI-743 and EPI-A0001 orally absorbed small molecules. Edison Pharmaceuticals, Inc. has a strategic alliance with Dainippon Sumitomo Pharma Co., Ltd. The company was founded in 2005 and is based in Mountain View, California with additional offices in the Netherlands. Edison Pharmaceuticals, Inc. operates as a subsidiary of Galileo Pharmaceuticals, Inc.

350 North Bernardo Avenue

Mountain View, CA 94043

United States

Founded in 2005

Phone:

408-960-2910

Fax:

408-413-5300

Key Executives for Edison Pharmaceuticals, Inc.

Chairman and Chief Executive Officer
Corporate Counsel and Secretary
Age: 55
Vice President of Intellectual Property
Vice President of Research & Development
Compensation as of Fiscal Year 2014.

Edison Pharmaceuticals, Inc. Key Developments

Edison Pharmaceuticals, Inc. Announces Phase 2 Positive Clinical Results for EPI-743 in Rett Syndrome

Edison Pharmaceuticals, Inc. announced results of a recently completed phase 2 placebo-controlled trial in pediatric patients. Rett syndrome patients treated with EPI-743 demonstrated a statistically significant increase in head circumference. Decreased brain growth and head circumference are hallmarks of the disease. Rett syndrome is a genetic neurodevelopmental disorder predominately affecting girls, and is usually diagnosed by 24 months of age. It is characterized by a constellation of neurological, behavioral, functional, and structural features. These include delayed development, characteristic hand wringing, seizures, impaired respiratory function, slowing of brain growth, and resultant diminished head size, as well as other neurological disorders. The double-blind, placebo-controlled clinical trial was conducted at the General University Hospital (Azienda Ospedaliera Universitaria Senese) of Siena. A total of 24 subjects, 2.5 to 8 years of age, were enrolled in the six-month trial. While the study did not meet the primary endpoint of improving the subjective Rett syndrome disease severity score, subjects treated with EPI-743 demonstrated an objective improvement in head growth. Specifically, head growth in the treatment group was 0.75 cm from baseline, compared to 0.29 cm in the placebo group (p=0.05). In a subgroup analysis of the children with the large head growth, improvements in oxygenation, hand function, and disease-relevant biomarkers were also recorded. These data will be submitted for publication in the near future.

Edison Pharmaceuticals, Inc. Presents at Baird's 2014 Healthcare Conference, Sep-04-2014 08:25 AM

Edison Pharmaceuticals, Inc. Presents at Baird's 2014 Healthcare Conference, Sep-04-2014 08:25 AM. Venue: The New York Palace, New York, New York, United States.

FDA Grants Edison Pharmaceuticals' EPI-743 Orphan Status for Leigh Syndrome

Edison Pharmaceuticals announced that the FDA has granted Orphan Drug status to vatiquinone for the treatment of Leigh syndrome. Vatiquinone is the International Nonproprietary Name (INN) for Edison's EPI-743. The INN is a unique international name issued by the World Health Organization, which is used to identify the active pharmacological ingredient in a drug. This is also known as the generic name. EPI-743 is currently in phase 2B/3 development for the treatment of Leigh syndrome. A phase 2B randomized double-blind placebo-controlled trial in children with Leigh syndrome is fully enrolled in the United States, and a phase 2B/3 trial of EPI-743, which is being conducted in conjunction with Dainippon Sumitomo Pharma Co, Ltd, is ongoing in Japan. Orphan designation was established as part of the Orphan Drug Act which was passed by the US Congress in 1983 to encourage the development of drugs for the treatment of rare, orphan diseases. The FDA grants orphan status to drugs that are being developed specifically to treat a rare condition and have shown potential benefit for the indication. Orphan designation affords several advantages including a more expedited drug approval process and an extended period of market exclusivity. Edison Pharmaceuticals has previously received Orphan Designation from the FDA for the treatment of inherited respiratory chain diseases of the mitochondria and Friedreich's ataxia, and from the European Medicines Agency Committee on Orphan Products and Japanese Ministry of Health, Labor and Welfare for the treatment of Leigh syndrome. EPI-743 is an orally bioavailable small molecule being developed by Edison Pharmaceuticals for inherited mitochondrial diseases, and is a member of the para-benzoquinone class of drugs. The mechanism of action of EPI-743 involves: augmenting the synthesis of glutathione; optimizing metabolic control; enhancing the expression of genetic elements critical for cellular management of oxidative stress; and acting at the mitochondria to regulate electron transport. The utility of EPI-743 is also being explored in other inherited respiratory chain disorders.

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