Spectrum Pharma Receives FDA Orphan Drug Exclusivity For EVOMELA - Quick Facts

(RTTNews) - Spectrum Pharmaceuticals (SPPI) announced the U.S. FDA Office of Orphan Products Development has granted 7 years of Orphan Drug Exclusivity for EVOMELA for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma.

Spectrum gained global development and commercialization rights to EVOMELA from Ligand Pharmaceuticals Incorporated (LGND) in March 2013. Spectrum assumed responsibility for completing the pivotal Phase 2 clinical trial, and was responsible for filing the NDA. Under the license agreement, Ligand received a license fee, and NDA approval milestone, and is eligible to receive further potential milestones and royalties.