Advanced Cell Technology Inc (ACTC) Profile and Financials, plus Biotechnology Industry Trends Analysis, Operating Ratios and Financial Averages
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Advanced Cell Technology, Inc. Granted EU Orphan Medicinal Product Designation For hESC-Derived Cells For Treatment Of Stargardt's Disease
Advanced Cell Technology, Inc.announced that that the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has officially granted ACT's human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells designation as an orphan medicinal product for the treatment of Stargardt's Macular Dystrophy (SMD). This follows on the U.S. Food & Drug Administration's (FDA) granting of Orphan Drug Designation for the same program from the Company, last year. Orphan Drug Designation by the European Commission provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons (less than 175,000 patients in total) in the European Union (EU). In addition to a 10-year period of marketing exclusivity in the EU after product approval, Orphan Drug Designation provides companies with scientific advice and regulatory assistance from the EMA during the product development phase, direct access to centralized marketing authorization, and reductions in certain fees associated with the application and approval process.
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