The US FDA has expanded the orphan drug designation for Pharmaxis' product Bronchitol. Bronchitol has been granted the additional indication of facilitating mucus clearance in patients with cystic fibrosis.

The orphan drug status entitles Pharmaxis to a range of incentives; these include a seven-year period of market exclusivity, assistance from the FDA with clinical trial design and an exemption from FDA User fees.

In February 2005, the FDA granted orphan drug designation for Bronchitol as a treatment for patients with bronchiectasis.

Alan Robertson, Pharmaxis chief executive officer said, "Pharmaxis now has a terrific opportunity to make a real difference to people with cystic fibrosis. There have been no therapeutic advances to help clear congested lungs for patients with cystic fibrosis in the past ten years. We are looking forward to working with the FDA on getting this important product to patients not just in the USA, but worldwide."

Pharmaxis has closed enrolment for its Phase II clinical trial for Bronchitol in cystic fibrosis in Australia. The company is conducting two further Phase II studies in cystic fibrosis patients to help determine the optimal dose of Bronchitol and examine the effects of using Bronchitol compared with existing treatments.