Proteo, Inc./Proteo Biotech AG: European Commission grants Orphan Drug Status to Elafin for the treatment of PAH.
IRVINE, Calif. & KIEL, Germany -- Proteo, Inc. (OTCBB OTCBB
See OTC Bulletin Board (OTCBB). : PTEO; WKN WKN Wertpapier-Kenn-Nummer (identifying number assigned to securities traded in Germany)
WKN Warrior Knowledge Network (US Army) : 925981) and its wholly-owned subsidiary Proteo Biotech AG announced today:
After recommendation by the European Medicines Agency The European Medicines Agency (EMEA) is a European agency for the evaluation of medicinal products. Until 2004, the European Medicines Agency was known as The European Agency for the Evaluation of Medicinal Products.
Roughly parallel to the U.S. (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ), Proteo Biotech AG has received orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the status from the European Commission for its drug candidate Elafin for the treatment of pulmonary arterial hypertension and chronic thromboembolic thromboembolic
pertaining to or emanating from thromboembolism.
see thromboembolic colic. pulmonary hypertension Pulmonary Hypertension Definition
Pulmonary hypertension is a rare lung disorder characterized by increased pressure in the pulmonary artery. The pulmonary artery carries oxygen-poor blood from the lower chamber on the right side of the heart (right . 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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 Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained
phase I , 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 Safe Harbor
1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.
2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. 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