Proteo's Elafin recommended for orphan drug status in Europe

Nov 16 2009

Proteo, Inc. (OTCBB: PTEO; Frankfurter Freiverkehr: WKN: 925981) and its wholly-owned subsidiary Proteo Biotech AG announced today:

The Committee for Orphan Medical Products (COMP) of the European Medicines Agency (EMEA) has issued a recommendation granting orphan drug status to Proteo's drug candidate Elafin for the treatment of esophagus carcinoma. The orphan drug status will become effective upon ratification of this recommendation by the European Commission. This is expected to occur in the last quarter of 2009. Elafin was also granted orphan drug status for the treatment of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension in 2007. This latest decision further highlights the considerable therapeutic potential of this drug.

Orphan drug status assures exclusive marketing rights for the treatment of the respective disease within the EU for a period of up to ten years after receiving market approval. In addition, a simplified, accelerated and less expensive approval procedure with the assistance of EMEA can be drawn upon. Patients undergoing esophagectomy for esophagus carcinoma are currently being treated with Elafin within the framework of a Phase II clinical trial. A follow-up study after completion of this trial in 2010 is already being planned.