Axentis Pharma AG signed an exclusive license with aRigen Pharmaceuticals Inc of Japan for the development and commercialisation of a drug delivery system for lung infections in cystic fibrosis patients, and a Phase II clinical trial will be initiated by Axentis in early 2008.
The license for the worldwide development and commercialisation of ARB-CF0223, excluding Japan and Korea. ARB-CF0223 is a patented encapsulating drug delivery system. The system has an improved safety profile, shows higher efficacy at lower doses, and also reduces the frequency and severity of exacerbations compared to current treatments.
Full terms were not disclosed but as part of the agreement aRigen received shares in Axentis, plus an undisclosed sum in cash.
Jörg Zielasek, President of Axentis said, “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 regulator 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.”
ARB-CF0223 is based on a well-characterised drug, tobramycin. Using liposomes that contain tobramycin, a proprietary nebulizer delivers the drug directly to the endobronchial sites of infection. This results in prolonged, high local drug concentration, which in turn achieves higher efficacy and lower doses.
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.
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