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Myogane granted European Unio
Myogane granted European Unio.
About this update from Ixico Plc
[{"type":"text","content":"\n RNS Number : 9258U Phytopharm PLC 21 May 2008 \n \n21 May 2008\n\nPhytopharm plc\n\nMyogane granted European Union Orphan Medicinal Product Designation for ALS\n\nGODMANCHESTER, Cambridgeshire, U.K. (21 May 2008) - Phytopharm plc (PYM: London Stock Exchange) ('Phytopharm' or the 'Company') announces today that the European Agency for the Evaluation of Medicinal Products ('EMEA') has awarded Orphan Medicinal Product Designation for Myogane™, a novel orally active neurotrophic factor inducer as a treatment for amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease), the most prevalent form of motor neurone disease. The Orphan Medicinal Product Designation provides Phytopharm with market exclusivity in the European Union for 10 years following Myogane™'s market authorisation.\n\nThe EMEA grants the Orphan Medicinal Product Designation for products that diagnose, prevent or treat life-threatening or very serious conditions affecting no more than five out of every 10,000 people in the European Union. ALS is a fatal neurodegenerative disease characterised by progressive degeneration of both upper and lower motor neurones which lead to severe muscle weakness and wasting followed by paralysis. Approximately 350,000 patients suffer from ALS worldwide, of which 50% die within 18 months of diagnosis. This condition has a high unmet medical need (source: Datamonitor). \n\nIn addition to the 10 year market exclusivity, incentives relating to the designation include protocol assistance from the EMEA to maximise the chance of success in achieving market authorisation, fee reductions relating to the application for marketing authorisation, and eligibility for grants from the European Union and member states supporting research and development. \n\nMyogane™ has previously been granted Orphan Drug status and Fast Track Designation for the treatment of ALS by the United States Food and Drug Administration (FDA).\n\nIn July 2007, Phytopharm successfully completed a Phase Ib study with Myogane™, conducted in the UK under a clinical trial authorisation (CTA) from the Medici...