TRACON Gets EMA Orphan Drug Designation Status For Its TRC105 in Soft Tissue Sarcoma

TRACON Pharmaceuticals

revealed that the European Medicines Agency (EMA) has granted orphan drug designation status for its TRC105 for the treatment of patients with soft tissue sarcoma. According to the company's President and CEO, Charles Theuer, "Orphan drug designation by the EMA for TRC105 for the treatment of soft tissue sarcoma represents an important regulatory milestone and indicates concurrence that TRC105 may offer significant benefit versus approved drugs for this rare disease. We look forward to presenting complete results from our Phase 2 sarcoma trial and initiating a pivotal Phase 3 trial in patients with angiosarcoma later this year." TRACON said that Orphan Drug Designation by the EMA Committee for Orphan Medicinal Products (COMP) offered regulatory, as well as, financial incentives to develop and market therapies that treat a life-threatening. Also, the rules provided that such drugs should treat chronically debilitating condition affecting no more than five in 10,000 persons in the European Union (EU). That was subject to no satisfactory treatment available. The company said that apart from a 10-year period of marketing exclusivity in the EU after product approval, Orphan Drug Designation status provided incentives for companies seeking protocol assistance from the EMA during the product development phase and direct access to the centralized marketing authorization procedure. Shares of the company shed 0.55% on Tuesday.