Regulatory Path for Bronchitol in Bron...( SYDNEY Australia May 1 /Xinhua-- ...)

SYDNEY, Australia, May 1 /Xinhua-PRNewswire-FirstCall/ -- Pharmaxis (AXS: PSX; Nasdaq: PXSL) today announced that it has agreed with advice from the U.S. Food and Drug Administration (FDA) on the design of a pivotal Phase 3 trial of the company's mucus clearing agent, Bronchitol, in patients with bronchiectasis.

The trial is a randomized, double-blind investigation of Bronchitol twice daily in approximately 300 adults with bronchiectasis. Participants will be treated for 52 weeks during which they will be assessed for reduction in frequency of exacerbations and quality of life. The trial will be undertaken in Europe and the USA.

This trial is the second Phase III study to be undertaken with Bronchitol in people with bronchiectasis and follows the completion of a successful trial reported during the third quarter of 2007. These trials are expected to form the basis of a marketing application in both the European Union and the U.S. Recruitment of volunteers will begin following receipt of the necessary approvals to begin the trial and is expected to be during the third quarter of 2008.

The clinical trial protocol requires final review by both the U.S. FDA under their Special Protocol Assessment (SPA) process and the European Medicines Agency, the EMEA.

The SPA process allows for FDA evaluation of a clinical trial protocol intended to form the primary basis of an efficacy claim in support of a New Drug Application, and provides an agreement that the study design, including trial size, clinical endpoints and/or data analyses are acceptable to the FDA.

Alan Robertson (Pharmaxis CEO) said, "To ensure that this pivotal trial can start quickly and be completed efficiently, Pharmaxis has assembled a specific advisory board of opinion leading physicians in bronchiectasis and employed clinical and regulatory staff in the US and EU. There are no products specifically approved for bronchiectasis and Bronchitol remains the only product cu
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