$AMBS News - Amarantus Granted European Union Orphan Drug Designation for MANF for the Treatment of Retinitis Pigmentosa

SAN FRANCISCO and GENEVA, - (http://www.financialnewsmedia.com News Alert) - Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on developing therapeutic and diagnostic products for neurological disorders and orphan indications, announced that the European Commission, acting on the positive recommendation from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP), has granted orphan drug status for MANF (mesencephalic-astrocyte-derived neurotrophic factor) for the treatment of retinitis pigmentosa (RP). RP refers to a group of inherited diseases causing retinal degeneration often leading to blindness. The Company previously announced in December of 2014 that it also received orphan drug designation for MANF for the treatment of RP from the U.S. Food and Drug Administration (FDA).



\"We are extremely pleased to have received European orphan drug status for our promising investigational product, MANF in RP,\" said Gerald E. Commissiong, President & CEO of Amarantus BioScience Holdings, Inc. \"This EU orphan designation, combined with our recent U.S. orphan designation, positions MANF for an accelerated global regulatory product development pathway to address the significant unmet need in this important ophthalmologic indication.\"



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), and where no satisfactory treatment is available. In addition to a 10-year period of marketing exclusivity in the EU after product approval, orphan drug designation provides incentives for companies seeking protocol assistance from the EMA during the product development phase, and direct access to the centralized authorization procedure.



David A. Lowe, Ph.D., member of the Amarantus Board Directors, commented, \"We believe MANF has potential as a promising potential treatment in multiple orphan ophthalmologic disorders. We intend to continue pursuing the orphan regulatory pathway for MANF as we move this program forward.\"



About Retinitis Pigmentosa



Retinitis pigmentosa (RP) refers to a group of inherited...