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Cystic Fibrosis - Orphan Drug Designation for Innovative Treatment Against Lung Infections by Axentis Pharma AG
Date:4/30/2009

Designation puts Axentis Pharma in a favourable position to register Fluidosomes-tobramycin in two major world markets with substantial support of the relevant authorities and at a cost advantage for the company. As a result, we will be able to deliver the product at competitive prices to patients once it has passed the final clinical test phase. In addition to this, the orphan drug designation grants Axentis several years of exclusive marketing rights once the product has been launched. That is a significant strengthening of Axentis Pharma market position as well as the company's value."

Fluidosomes-tobramycin combines the companys proprietary Fluidosomes technology with the well-established generic drug tobramycin. Utilising synthetic liposomes containing tobramycin, a standard nebulizer delivers the drug directly to the endobronchial sites of infection in cystic fibrosis patients. This may result in prolonged high local drug concentration in the lung, which in turn may lead to higher efficacy and may allow lower doses.

Currently, the company is initiating Phase II clinical trials that will assess the safety and tolerability of a new therapeutic formulation as well as the effects of two different doses of the new drug. Results of the clinical trial are expected early 2010.

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

Axentis Pharma is a respiratory specialty pharmaceutical company which core competence is the application of a fully patented, encapsulating drug delivery system to already established and well-characterized therapeutic agents. Currently, the company is using this technology, named Fluidosome(R) technology, for the development of its lead product, a clinical stage treatment against cystic fibrosis (CF).

About Fluidosome technology

Axentis Pharmas Fluidosome technology uses biocompa
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SOURCE Axentis Pharma AG
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