(MENAFN- ProactiveInvestors)Amarantus BioScience Holdings (OTCQB: AMBS) reached a key milestone - receiving orphan drug status from the powerful FDA for Eltoprazine for treating the involuntary movements associated with Parkinson's disease. Levodopa-induced dyskinesia (PD-LID). can be severely disabling rendering patients unable to perform routine daily tasks. The Parkinson's Disease Foundation estimates that there were around 1mln people living with Parkinson's disease in the USA in 2011. At around this time last year Amarantus published positive results from a Phase 2 initial proof-of-concept clinical study. "The grant of this orphan drug designation for eltoprazine in PD-LID squarely positions Amarantus as an orphan drug company as each of our pipeline candidates in our therapeutics division has received such designations from the FDA for one or more indications" said Gerald E. Commissiong chief executive "PD-LID is a tremendously debilitating disorder and we will now begin evaluating expedited pathways to market for eltoprazine that may now be afforded by the orphan drug designation." Orphan drug status is for drugs intended to treat diagnose or prevent diseases that affect fewer than 200000 people in the US. It provides for a seven year marketing exclusivity period against competition as well as certain incentives including federal grants and tax credits.
Legal Disclaimer:
MENAFN provides the information “as is” without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the provider above.