Wednesday, May 20, 2015 8:35:56 AM
NEWS Orphan Drug Status
PlasmaTech Biopharmaceuticals Announces Orphan Drug and Rare Pediatric Disease Designations From FDA Two FDA Designations for Both ABX-101 and ABX-102 for Sanfilippo Syndromes (MPS IIIA and MPS IIIB) NEW YORK, NY--(Marketwired - May 20, 2015) - PlasmaTech Biopharmaceuticals, Inc. (NASDAQ: PTBI), a biopharmaceutical company focused on gene therapy and plasma-based products for severe and life- threatening rare diseases announced today that the U.S. Food and Drug Administration (FDA) had granted both Orphan Drug Designation and Rare Pediatric Disease Designation for both of PlasmaTech Biopharmaceuticals' lead product candidates for the treatment of Sanfilippo Syndromes A and B. "We are very pleased to announce that the FDA has provided these two important designations to our Sanfilippo drug candidates, reflecting their potential to address the significant unmet medical needs of children with these rare and devastating lysosomal storage diseases," stated Tim Miller, Ph.D., President & CEO of PlasmaTech Biopharmaceuticals. "The benefits and incentives associated with these designations, including marketing exclusivity periods and the potential to obtain two valuable Pediatric Disease Priority Review vouchers, are strategically important from a regulatory and commercial perspective and potentially very value-creating for shareholders." "These important FDA designations reflect the critical nature of these two programs to these patients and families," noted Steven H. Rouhandeh, PlasmaTech's Executive Chairman. "PlasmaTech's programs in MPS IIIB & IIIA address compelling unmet medical needs with breakthrough technology. We are committed to building on these achievements, and intend to continue to expand our product pipeline in the rare disease space." Less
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