Bronchitol had already received orphan drug status from both the FDA and European Medicines Agency for treating Cystic Fibrosis. It works by clearing mucus buildup in the lungs of sufferers.
There are currently no other drugs or treatments aimed at hydrating the lungs of Cystic Fibrosis patient. Bronchitol is currently being investigated in Phase III and Phase II trials in Europe, Canada, Argentina, and Australia. Previous Phase II studies showed a significant improvement in lung function.
Fast track status allows Pharmaxis to submit data and information during the clinical trials, and does not have to wait until the trial is completely finished. This gives the FDA an opportunity to review the results as they become available, speeding up the regulatory approval.
The final data submission is expected to take place in 2008.
Pharmaxis currently holds $75 million in cash and equivalents, and carries no debt. Shares of Pharmaxis were up as much as 20% during midday trading on Friday.
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