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Cystic Fibrosis: License Agreement Boosts Development of Therapy Against Lung Infections
Date:12/19/2007

ZURICH, Switzerland, December 19 /PRNewswire/ -- An exclusive license for the development and commercialisation of a drug delivery system for lung infections in Cystic Fibrosis patients was signed today. As part of the agreement, aRigen Pharmaceuticals Inc., Japan transferred relevant rights to Axentis Pharma AG of Switzerland. The EMEA has already granted orphan drug status to the licensed technology and a phase II clinical trial will be initiated by Axentis Pharma AG in early 2008.

Axentis Pharma AG (Switzerland) and aRigen Pharmaceuticals, Inc. (Japan) announced today the signature of a license agreement for the development of therapy against lung infections in Cystic Fibrosis patients. Under the terms of the agreement Axentis Pharma AG purchased from aRigen Pharmaceuticals, Inc. an exclusive license for the development and commercialisation of ARB-CF0223 worldwide except Japan and Korea. ARB-CF0223 is a fully patented, innovative encapsulating drug delivery system for the treatment of pulmonary infections in patients with Cystic Fibrosis. The system has an improved safety profile, higher efficacy and lower doses, and also reduces the frequency and severity of exacerbations compared to current treatments for pulmonary infections in patients with Cystic Fibrosis. As part of the agreement aRigen Pharmaceuticals, Inc. received shares of Axentis Pharma plus an undisclosed sum in cash.

Jorg Zielasek, President of Axentis Pharma AG, commented that: "The purchase of the license from aRigen Pharmaceuticals grants Axentis the right to further develop and commercialise an extremely promising treatment for chronic lung inflammation, the most severe consequence of Cystic Fibrosis. The agreement means that Axentis can now initiate an immediate phase II clinical trial in Germany. The design of the study has already been approved by the EMEA, which has also granted orphan drug status to ARB-CF0223. This is a very promising prospect for both Cystic Fibrosis patients and investors in Axentis."

Mr. Toru Gensuke Tokoro, President and CEO of aRigen Pharmaceuticals, Inc. adds: "ARB-CF0223 is based on a well-characterised drug, Tobramycin. Utilising synthetic liposomes that contain Tobramycin, a proprietary nebulizer delivers the drug directly to the endobronchial sites of infection in Cystic Fibrosis patients. This results in prolonged, high local drug concentration, which in turn achieves higher efficacy and lower doses. We are pleased that a competent partner such as Axentis Pharma will further develop this promising product."

The drug has already been tested successfully in a phase I single-dose inhalation study. No significant adverse events were observed when the liposomal formulation of Tobramycin was compared with the currently marketed formulation in 24 healthy volunteers who were treated in a crossover fashion.

About Cystic Fibrosis

Cystic Fibrosis (CF) is the most common life-threatening inherited multi-organ disease in Caucasians and is caused by a mutation in the CFTR-gene (cystic fibrosis transmembrane conductance regulator) on chromosome 7. The defective gene leads to viscous secretions and impaired mucociliary clearance. The most devastating clinical consequence of CF and cause of morbidity and mortality is lung involvement. A striking feature of lung involvement is the endobronchial colonisation with the bacterial strain Pseudomonas aeruginosa. Chronic inflammation contributes to obstructive lung disease and tissue destruction leading to bronchiectasis and respiratory failure.

About Axentis Pharma AG (http://www.axentispharma.com)

Axentis Pharma AG is a Swiss biotech company. The company owns proprietary technology used in the treatment of diseases, the etiology of which is misrouted or misfolded proteins, for example, cystic fibrosis, nephrogenic diabetes insipidus, hypercholesterolemia and others. Axentis is managed by a team of experienced entrepreneurs.

About aRigen Pharmaceuticals, Inc. (http://www.arigen.jp)

aRigen Pharmaceuticals, Inc. is a leading Japanese drug discovery and development company working on new molecular entities for infectious diseases. With a vision of "Discovered in Japan for Global Health" the company discovers pharmaceutical compounds in Japan in cooperation with leading Japanese life scientists, and develops them into innovative drugs for the global population. Several of its development programmes have already advanced to the clinical stage.

For further information please contact:

Axentis Pharma AG:

Leuholz 14, 8855 Wangen, Switzerland,

T +41-44-817-7817,

F +41-44-817-7818,

E board@axentispharma.com;

aRigen Pharmaceuticals, Inc.:

7-3-37/3F, Akasaka, Minato-ku, Tokyo 107-0052, Japan,

T +81-3-3470-3310,

F +81-3-3470-3345,

E bdd@arigen.jp;

Copy Editing & Distribution:

PR&D - Public Relations for Research & Development,

Michaela Fritsch,

Campus Vienna Biocenter 2, 1030 Vienna,

T +43-1-505-70-44,

E contact@prd.at.


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SOURCE Axentis Pharma AG
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