Proteo Inc./Proteo Biotech AG: European Commission grants Orphan Drug Status to Elafin for the treatment of PAH
Published: Mar 29, 2007
IRVINE, Calif. & KIEL, Germany--(BUSINESS WIRE)--Proteo, Inc. (OTCBB: PTEO; WKN: 925981) and its wholly-owned subsidiary Proteo Biotech AG announced today: After recommendation by the European Medicines Agency (EMEA), Proteo Biotech AG has received orphan drug status from the European Commission for its drug candidate Elafin for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. This assures the company exclusive marketing rights within the EU for a period of up to ten years after receiving approval. In addition, its designation as an orphan drug will allow access to a centralized approval procedure which will accelerate the process of approval in all EU states. Birge Bargmann, CEO of Proteo Biotech AG, »We are confident that within a few years Elafin will be available as a new therapeutic option for the treatment of this serious disease.« In her estimation, the orphan drug designation of Elafin has not only increased awareness of this drug, but has also strengthened the company's expertise in drug regulatory affairs.