On March 25, 2016 OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, reported that the European Commission has granted orphan drug designation to CA4P for the treatment of gastro-entero-pancreatic neuroendocrine tumors (NETs) (Press release, OXiGENE, MAR 25, 2016, View Source [SID:1234509973]). Schedule your 30 min Free 1stOncology Demo! The designation provides for ten years of marketing exclusivity in European Union (EU) member countries following product approval. Earlier this year OXiGENE announced that CA4P received orphan drug designation from the U.S. Food and Drug Administration for NETs, which provides for seven years of marketing exclusivity after approval.
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"I am pleased that the EU has provided the orphan designation to CA4P for neuroendocrine tumors," stated William D. Schwieterman, M.D., President and Chief Executive Officer of OXiGENE. "This designation represents another successful step as we execute on our strategy of bolstering the proprietary position of CA4P in the potential indications in which we are most interested. Separately, we continue to expect final data from our phase 2a clinical trial of CA4P in NETs to be available later in 2016."
Orphan designation in the EU is granted to product candidates that are intended to treat life-threatening or chronically-debilitating conditions that affect no more than five patients per 10,000 of the EU population. Among other benefits, orphan designation provides for regulatory assistance and scientific advice from the European Medicines Agency during product development.