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Transave Completes Enrollment in Arikace(TM) Phase II Bronchiectasis Study
Date:4/21/2009

ost frequent pathogens infecting bronchiectasis patients is Pseudomonas aeruginosa, which is associated with increased sputum production, more extensive bronchiectasis, more hospitalizations, and reduced quality of life.

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.

About Arikace (liposomal amikacin for inhalation)

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 has been initiated 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.

About PARI Pharma and the eFlow(R) Electronic Nebulizer

Arikace is delivered by an Investigational eFlow Nebulizer System developed by PARI Pharma GmbH. The I
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SOURCE Transave, Inc.
Copyright©2009 PR Newswire.
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