Read Fact sheet Proteo April 2008 text version


Am Kiel-Kanal 44 D-24106 Kiel Germany +49-431-8888-462 +49-431-8888-463 [email protected] 2000 Drug discovery and development Elafin Phase II (i.v.) Orphan Drug Status EU PAH ($ 890 Mio., expected to grow up to $ 2 bn.) SIRS (exp. > $ 1 bn.) COPD ($ 3,2 bn) Cystic fibrosis ($ 450 Mio.) Myocardial infarction ($ 3 bn) Transplantations ($ 890 Mio.) Severe injuries ($ 3 bn) Minapharm Pharmaceuticals SAE, Cairo, Egypt Artes Biotechnology GmbH University of Kiel, SFB 617 HBT Hycult Biotechnology B.V., Uden, Netherlands Eurogentec S.A., Seraing, Belgium IKP, Institut für klinische Pharmakologie, Kiel University of Alberta, Canada Stanford University, USA Birge Bargmann (CEO) Oliver Wiedow, MD (Chairman of the Board) Barbara Kahlke, PhD (Member of the Board) Florian Wegner (Member of the Board)

Summary Proteo Biotech AG is located in Kiel, Germany and is dedicated to the development of new drugs based on naturally occurring compounds. Especially proteins of human origin offer a unique source of potential pharmaceuticals with a low risk of unforeseeable side effects. The Company's Phase II lead product Elafin is a highly potent down regulator of tissue destruction in the course of inflammatory diseases, especially those affecting blood vessels, lungs or muscles. Elafin may be used for i.v. or aerosol treatment of myocardial infarction, transplantation, reperfusion injuries and COPD, each comprising billion $ markets worldwide. The Company's focus is on the development of orphan drug indications.

Telephone Fax Email Address Website Founded (year) Areas of Activity Lead Product Development Status Addressed Markets

External Collaborations

Company Proteo Biotech AG is located in Kiel, Germany. The Company was founded in April 2000 as a spin-off from the University of Kiel. Proteo currently operates 2 facilities in Kiel; one of the facilities, the pilot plant for recombinant production of proteins, is used to conduct the fermentation and purification processes. The second site includes analytical laboratories as well as office space. Proteo Biotech AG is a wholly owned subsidiary of Proteo, Inc. USA. Proteo, Inc. is a publicly traded company and is quoted on the NASDAQ-OTC BB (Ticker: PTEO) and on the Frankfurt and Berlin Stock Exchange (Freiverkehr: WKN 925981).


Elafin, Phase II Product Elafin is a soluble endogenous protein of the human body and a natural inactivator of two tissue destroying enzymes, neutrophil elastase and proteinase-3, both known as major factors in inflammation. Furthermore, Elafin inactivates endogenous vascular elastase, an enzyme involved in inflammatory vascular damage. Elafin is a small and unusually stable human protein. Elafin may be applied therapeutically by infusion or inhalation.

Development status Proteo has successfully established a drug production process for Elafin employing genetically modified yeasts. Initial toxicity studies and encouraging pharmacokinetic data have been collected. Elafin has been administered intravenously to healthy human volunteers in a dose escalating clinical Phase I Trial. Elafin infusions were well tolerated. The European Commission granted Orphan Drug Status for Elafin for the treatment of pulmonary arterial hypertension and chronic thrombembolic pulmonary hypertension. A Phase II clinical trial on patients undergoing esophagectomy for esophagus carcinoma has been started in the University Hospital of Schleswig-Holstein, Campus Kiel in November 2008. A further Phase II clinical trial has already been approved: Minapharm Pharmaceuticals SAE, Cairo, will initiate a Phase II clinical trial to study the efficacy of Elafin on kidney transplant patients. The study will be conducted as a Phase II trial for prevention of acute and chronic allograft nephropathy at the University of Cairo.

Scope of Applications Proof of concept studies in animals show that Elafin is potentially highly effective in the treatment of several diseases, particularly of · Pulmonary diseases, such as pulmonary pulmonary

Product Pipeline The medical leech-derived protein LDTI, which is an inhibitor of human mast cell tryptase, is under preclinical development. Initial results indicate that LDTI might be applicable in the treatment of mast cellmediated diseases. In addition, a group of naturally occurring immuno-stimulatory substances from yeasts (LILA) are undergoing pre-clinical evaluation. Elafin Patent Protection Proteo's core product Elafin is covered by patents granted in the US, Europe and several other countries. Additional patent applications are currently in preparation. Proteo holds an exclusive, world-wide long term license for the use of the yeast strain employed in the production of Elafin. Strategy The Company intends to develop proprietary products targeting rare diseases, so-called orphan drugs. Orphan drug status in the US as well as in Europe provides eased drug approval procedures and protected market access for up to seven or ten years, respectively. Due to the clearly definable product target groups, Proteo finds itself capable of marketing these products with its own sales organization. However, Proteo will also evaluate the advantages of cooperating with distribution partners. The Company actively seeks R&D partnerships and licensees for specified applications and selected markets world-wide, while simultaneously attempting to attract the financial community and major investors.

hypertension, chronic obstructive disease (COPD) and cystic fibrosis; ·

Reperfusion injuries due to myocardial infarction, transplantation, severe injuries or other tissue damage occurring on restoring blood circulation.

Due to its unique mode of action Elafin has further potential to be used in SIRS, acute pancreatitis, periodontitis, wound healing, and other inflammatory indications as well as in the area of medical device coating and of cosmeceuticals. Markets The potential major applications of Elafin (COPD, reperfusion injuries, SIRS, transplantation) each address markets well exceeding or close to $ 1 billion in the US and in the EU, respectively. Although to be considered Orphan Drug Markets, pulmonary arterial hypertension (PAH) and cystic fibrosis, both targeted by the Company, actually exceed $ 890 million and $ 450 million worldwide. Both markets are expected to grow significantly and PAH is estimated to reach blockbuster status in the mid term with a market potential of $ 2 bn.


Fact sheet Proteo April 2008

2 pages

Report File (DMCA)

Our content is added by our users. We aim to remove reported files within 1 working day. Please use this link to notify us:

Report this file as copyright or inappropriate


You might also be interested in

Fact sheet Proteo April 2008