US Orphan Drug status for Bexion's Saposin C for glioblastoma

Privately-held US biotech firm Bexion Pharmaceuticals has received Orphan Drug designation for the US Food and Drug Administration for Saposin C, the active ingredient in its proprietary drug BXQ-350 for the potential treatment of glioblastoma multiforme.

BXQ-350 is a proprietary nanovesicle formulation of sphingolipid activator protein C, or Saposin C, and the phospholipid dioleoylphosphatidylserine.

The successful application submitted by Bexion and the FDA granting of Orphan Drug status entitles the company to a seven-year period of marketing exclusivity in the USA for BXQ-350, if it is approved by the agency for the treatment of glioblastoma multiforme. Orphan Drug status also enables the company to apply for research grant funding for Phase I and II Clinical Trials, tax credits for certain research expenses, and a waiver from the FDA's application user fee, as well as additional support from FDA and a potentially faster regulatory process.