The Therapeutic Goods Administration (TGA) of Australia has approved Pharmaxis' requests to supply its unapproved drug, Bronchitol, to patients with bronchiectasis who participated in recent clinical trials.

The TGA requires that pharmaceuticals are approved and registered before they can be supplied. Exemptions are occasionally granted under the Special Access Scheme (SAS) for the supply of unapproved pharmaceuticals such as Bronchitol, to seriously ill patients.

Under the SAS, a patient's doctor applies to the TGA for approval to request the needed drug from the manufacturer. Patients, doctors and the manufacturer are all obliged to carefully monitor and report the safety of the drug and the balance of its benefits and risks. In these cases, Pharmaxis will supply Bronchitol to a number of patients in NSW and Victoria.

Pharmaxis CEO Alan Robertson said, "This is a wonderful opportunity for Pharmaxis to help people living with bronchiectasis. To breathe easily is something most people take for granted: making that possible for these patients is very gratifying."

Bronchitol is still in development. Clinical studies have shown it to be well tolerated, safe and effective in stimulating mucus hydration and clearance in people with chronic obstructive lung diseases. In particular, Bronchitol has been shown to dramatically increase mucus clearance from the lungs and significantly improve quality of life for people with bronchiectasis. Pharmaxis' Phase II clinical trials for bronchiectasis are complete and
Phase III pre-registration trials are beginning.