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Transave Announces Positive Phase II Results For Once-Daily ARIKACE(TM) in the Treatment of Non-CF Bronchiectasis Patients Who Have Pseudomonas Lung Infections
Date:9/14/2009

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The disease is often misdiagnosed and mistaken for asthma or pneumonia. There is currently no drug specifically approved for the treatment of bronchiectasis or the associated lung infections in the U.S. or EU.

About ARIKACE(TM)

ARIKACE is a form of the antibiotic amikacin, which is enclosed in nanocapsules of lipid called liposomes. This advanced pulmonary liposome technology prolongs the release of amikacin in the lungs while minimizing systemic exposure. The treatment uses biocompatible lipids endogenous to the lung that are formulated into small (0.3 micron), neutrally-charged liposomes that enable penetration of the biofilm and are highly efficient, with a very low lipid-to-drug ratio (0.65). ARIKACE can be delivered through nebulization, which enables the small aerosol droplet size (1 to 5 microns) to facilitate more effective distribution in the lungs. In addition to this clinical study in non-CF bronchiectasis patients with Pseudomonas lung infections, clinical development is underway in CF patients with Pseudomonas lung infections, with positive Phase II results reported in June 2008. ARIKACE has been granted orphan drug status in the United States by the FDA, and has received an orphan drug designation in Europe by the European Medicines Agency for the treatment of Pseudomonas infections in patients with CF. ARIKACE has also been granted orphan drug status by the FDA for the treatment of bronchiectasis in patients with Pseudomonas or other susceptible pathogens.

About PARI Pharma and the eFlow(R) Electronic Nebulizer

ARIKACE is delivered by an eFlow Nebulizer System developed by PARI Pharma GmbH. The eFlow Nebulizer System uses eFlow Technology to enable highly efficient aerosolization of medication including liposomal formulations via a vibrating, perforated membrane that includes
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SOURCE Transave, Inc.
Copyright©2009 PR Newswire.
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