Soligenix Inc. (NASDAQ: SNGX) announced that the European Commission granted orphan drug designation to dusquetide, the active ingredient in SGX945, for treating Behçet's Disease. The designation followed a positive recommendation from the European Medicines Agency Committee for Orphan Medicinal Products after reviewing published Phase 2a clinical results.

The European orphan drug designation provides 10 years of marketing exclusivity in the European Union after product approval. It also offers incentives for protocol assistance during development and direct access to centralized authorization procedures. The European Commission grants orphan designations for medicines treating life-threatening or chronically debilitating conditions affecting no more than five in 10,000 persons in the EU where no satisfactory treatment exists.

SGX945 previously received orphan drug and fast track designations from the U.S. Food and Drug Administration for Behçet's Disease treatment. The drug also received Promising Innovative Medicine designation from the UK's Medicines and Healthcare Products Regulatory Agency.

"We are extremely pleased to have received European orphan drug designation for the SGX945 program," stated Christopher J. Schaber, President and Chief Executive Officer of Soligenix. "Behçet's Disease is an area of unmet medical need, with up to 18,000 people in the U.S., 50,000 people in Europe, 350,000 people in Turkey and as many as 1 million people worldwide affected by this incurable disease."

Behçet's Disease is an inflammatory blood vessel disorder commonly diagnosed in young adults. Major symptoms include mouth sores in approximately 95% of patients, skin rashes and lesions in about 50% of patients, and genital sores in roughly 50% of patients. The condition has no cure, with treatments focused on managing symptoms.