Press
 

Company press release

 

Proteo, Inc./Proteo Biotech AG: European Medicines Agency EMEA recommends Orphan Drug Designation for Elafin

Irvine, CA – Feb. 12 2007 – Proteo, Inc. (OTCBB: PTEO; WKN: 925981) and its wholly-owned subsidiary Proteo Biotech AG announced today:

The Committee for Orphan Medical Products (COMP) of the European Agency for the Evaluation of Medicinal Products (EMEA) has adopted a positive opinion recommending the granting of orphan medicinal product designation for Elafin for treatment of pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. The orphan drug designation will become effective upon adoption of this recommendation by the European Commission. This is expected to occur in the first quarter of 2007.

Birge Bargmann, Proteo's CEO: “Orphan drug designation allows for up to ten years of market exclusivity within the European Communities to a drug substance for the respective disease upon receipt of drug approval. Moreover, after Orphan Drug designation, Elafin may enjoy a simplified, expedited and cheaper drug approval procedure as well as EMEAs regulatory guidance in the clinical development process until drug approval.”

Pulmonary arterial hypertension (PAH) is continuous high blood pressure in the pulmonary artery. If untreated the median survival is 2–3 years from time of diagnosis. Despite the treatment progress during the last two decades the disease is still life threatening and there is an unmet medical need for additional treatments. Worldwide treatment costs for pulmonary arterial hypertension with specific drugs are expected to exceed $2 billion in 2014 annually (source: Datamonitor 2006).

Elafin, a human protein, has shown very good tolerability in a clinical phase I study. Elafin blocks the activity of such enzymes that are involved in pulmonary arterial hypertension. This makes Elafin a highly promising compound for the treatment of the disease. Dr. Oliver Wiedow, Chairman of the Board of Proteo Inc.: “The positive opinion of the EMEA committee on orphan medicinal products is a milestone for our development of a completely new therapy for this life-threatening disease, with a mode of action which is independent of the mode of action of all existing therapies. We are pleased that Dr. Marius Hoeper, Dept. of Pulmonology, University of Hannover, a leading specialist in the field of pulmonary arterial hypertension, has supported this application.“

About Proteo

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).

Forward-Looking Statements

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.

Contact

Barbara Kahlke, Ph.D.
Proteo Biotech AG
Am Kiel-Kanal 44
D-24106 Kiel

Email: info@proteo.de
Telephone: +49 431 8888-462
Fax: +49 431 8888-463

https://proteo.us/proteo-inc/press/press-releases/2007/02/12/proteo-inc-european-medicines-agency-emea-recommends-orphan-drug-designation-for-elafin/ – printed on 2019-11-04 22:44:41