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Cystic Fibrosis: License agreement boosts development of therapy against lung infections

21 Dec 2007 - Axentis Pharma AG (Switzerland) and aRigen Pharmaceuticals, Inc. (Japan) announced 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.
 
Jörg 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."
 
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.