Amarantus BioScience Holdings, Inc., (OTCBB: AMBS) Has Received Orphan Drug Designation from the US FDA

FAR ROCKAWAY, NY / ACCESSWIRE / February 11, 2016 / Amarantus BioScience Holdings, Inc., (OTCBB: AMBS) a biotechnology company focused on developing products for Regenerative Medicine, Neurology and Orphan Diseases, recently announced that it has received orphan drug designation from the US FDA for Eltoprazine in the treatment of Parkinson’s disease levodopa-induced dyskinesia (PD-LID). Amarantus published positive results from a Phase 2 initial proof-of-concept clinical study in February of 2015 in the journal Brain, and highlighted the publication of two independent peer-reviewed scientific publications describing the mechanism of action of Eltoprazine for the treatment of PD LID in August of 2015 and December 2016.

The FDA Orphan Drug Designation program provides a special status to drugs and biologics intended to treat, diagnose or prevent so-called orphan diseases and disorders that affect fewer than 200,000 people in the U.S. This designation provides for a seven year marketing exclusivity period against competition, as well as certain incentives, including federal grants, tax credits and a waiver of PDUFA filing fees.

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