After recommendation by the European Medicines Agency (EMEA), Germany-based Proteo Biotech AG, a wholly-owned unit of the USA's Proteo Inc, has received Orphan Drug status from the European Commission for its drug candidate Elafin, an elastase-specific inhibitor, for the treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.
Birge Bargmann, chief executive Proteo Biotech, said: "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 designation of Elafin has not only increased awareness of this drug, but has also strengthened the company's expertise in drug regulatory affairs.
Proteo said that it intends to out-license selected indications for the product and to establish international strategic alliances in order to open up new fields of application and marketing.
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