BronchitolTM Receives Fast-Track Status

November 28, 2006

The U.S. Food and Drug Administration (FDA) has granted fast-track status to BronchitolTM, a potential new drug being tested for treatment of cystic fibrosis lung disease. Fast-track status allows a quicker review of potential therapeutics that are intended to fulfill an unmet medical need and treat a serious or life-threatening condition such as CF.

The Australian pharmaceutical company Pharmaxis, the producer of BronchitolTM, is working closely with the FDA to ensure that the drug will reach the CF community as quickly as possible following the completion of clinical trials.

BronchitolTM is a dry powder formulation of mannitol, a naturally occurring sugar alcohol, that is provided in a hand-held inhaler. Inhaled mannitol has been safely tested in more than 4000 people worldwide. The drug is designed to draw water into the airways, moistening and thinning the sticky mucus found in the lungs of people with CF and making it easier to cough it out. BronchitolTM was shown in Phase 2 clinical trials in Australia and New Zealand to be safe and well-tolerated and significantly improved lung function in volunteers with CF.

A larger, Phase 3 trial of BronchitolTM is underway in volunteers with CF to demonstrate an improvement in lung function and quality of life, and reduced infections and physiotherapy needs. Due to fast-track status, results from these trials are presented to the FDA for review as they become available. A complete submission and request for marketing approval is expected in 2008.