Amarantus Seeking Rare Pediatric Disease, Orphan Drug Designations for ESS Graft

A San Francisco biotech is filing for rare pediatric disease and orphan drug classifications for its engineered skin substitute.

The ESS graft, developed by Amarantus BioScience, would be used to treat the rare skin disease giant congenital melanocytic nevi, which causes dark patches in infants and is linked to an increased chance of melanoma.

If approved, the designations would place ESS at an advantage for a priority review voucher, as well as a seven-year marketing exclusivity period and tax credits.