Proteo, Inc./Proteo Biotech AG: European Commission grants Orphan Drug Status to Elafin for the treatment of PAH.
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, eWe are confident that within a few years Elafin will be available as a new therapeutic option for the treatment of this serious disease.y 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.
Professor Oliver Wiedow, Chairman of the Board, Proteo Biotech AG, eAfter the promising results of the Phase I clinical trial, the multicenter studies to establish clinical efficacy, which are necessary for approval, now lie ahead of us.y
PROTEO Biotech AG, based in Kiel, Germany was founded in April 2000 and in the same year was taken over by the US-American holding company PROTEO Inc. The company researches, develops and markets compounds for biological and medical research as well as for use as pharmaceuticals. PROTEO holds the production and utilization rights for recombinant human Elafin. PROTEO intends to out-license selected indications and to establish international strategic alliances in order to open up new fields of application and for marketing. The federal state of Schleswig-Holstein funds the innovative development venture of PROTEO Biotech AG with money from the European Fund for Regional Development (EFRE).
Certain statements in this news release may contain forward-looking information within the meaning of Rule 175 under the Securities Act of 1933 and Rule 3b-6 under the Securities Exchange Act of 1934, and are subject to the safe harbor created by those rules. All statements, other than statements of fact included in this release, including, without limitation, statements regarding potential future plans and objectives of the company, are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Technical complications that may arise could prevent the prompt implementation of any strategically significant plan(s) outlined above. The company cautions that these forward looking statements and risks and uncertainties involved are further qualified by other factors including, but not limited to those set forth in the company's Form 10-KSB filing and other filings with the United States Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any statements in this release, whether as a result of new information, future events or otherwise.
Further information: www.proteo.de