- Late-stage biopharmaceutical company Soligenix (NASDAQ:SNGX) announces it received orphan drug designation from the European Commission for SGX301. SGX301 is a novel first-in-class photodynamic therapy utilizing safe visible light for activation that is being developed for the treatment of cutaneous T-cell lymphoma (CTCL), a rare disease and a class of non-Hodgkin's lymphoma.
- Orphan drug designation in will provide Soligenix with various development incentives, including a 10-year period of marketing exclusivity in the EU after product approval, protocol assistance from the EMA during the product development phase, and direct access to the centralized authorization procedure.
- SGX301 has previously been granted both orphan drug and fast track designations from the FDA for the first-line treatment of CTCL.
- The company is currently working to initiate a 120 subject pivotal Phase 3 clinical trial with SGX301 in 2H 2015.
- Previously: Soligenix gets orphan designation for SGX94 (Sept. 16, 2013).