ACT Receives Positive Opinion for Orphan Drug Designation from European Medicines Agency for hESC-Derived RPE Cells for Treatment of Stargardt's Disease
Press Release Source: Advanced Cell Technology, Inc. On Thursday March 10, 2011, 8:30 am
MARLBOROUGH, Mass., March 10, 2011 /PRNewswire/ -- Advanced Cell Technology, Inc. (“ACT”; OTC Bulletin Board: ACTC), a leader in the field of regenerative medicine, announced today that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has announced a positive opinion of ACT's human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells for designation as an orphan medicinal product for the treatment of Stargardt's disease. This opinion will now be forwarded by the EMA to the European Commission for their adoption, which should follow in coming weeks. This follows on the US Food & Drug Administration's granting of Orphan Drug Designation for the same program from ACT, last year.
"We are very pleased to receive this positive opinion for Orphan Drug Designation from the EMA for our hESC-derived RPE cells for the treatment of Stargardt's disease," said Gary Rabin, ACT's interim chairman and CEO. "There is currently no approved treatment for Stargardt's disease, and we are working diligently to move this European trial forward as quickly as possible."
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 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, as well as reductions in certain fees associated with the application and approval process.
