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news.Phytopharm has announced that the European Agency for the Evaluation of Medicinal Products has awarded orphan medicinal product designation for Myogane, a novel orally active neurotrophic factor inducer as a treatment for amyotrophic lateral sclerosis, the most prevalent form of motor neurone disease.
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The orphan medicinal product designation provides Phytopharm with market exclusivity in the EU for 10 years following Myogane’s market authorization. In addition to the 10 year market exclusivity, incentives relating to the designation include protocol assistance from the EMEA to maximize the chance of success in achieving market authorization, fee reductions relating to the application for marketing authorization, and eligibility for grants from the EU and member states supporting research and development.
Daryl Rees, CEO of Phytopharm, said: “Myogane readily enters the central nervous system and has the potential to induce a person’s own neurotrophic factor activity and alter disease progression. Our pre-clinical studies have been highly encouraging in both quality of life and survival parameters and we look forward to further clinical progress in amyotrophic lateral sclerosis patients (ALS) later this year, subject to additional grant funding.”