Investor Centre

Pharmaceutical company Pharmaxis (ASX: PXS) announced it will meet this week with representatives of the Food and Drug Administration (FDA) to discuss the key parameters of the clinical trial necessary to  secure approval for Bronchitol® (mannitol) for the treatment of cystic fibrosis in the USA.

The Type A meeting with the Division of Pulmonary, Allergy and Rheumatology Products (DPARP) will be attended by members of Pharmaxis’ medical and regulatory teams and will take place in Maryland, USA.

Pharmaxis CEO Mr Gary Phillips said, “This meeting is an opportunity for a structured discussion with the FDA on key points of its evaluation of the Company’s New Drug Application and the pathway for approval of Bronchitol. Pharmaxis is seeking guidance so it can design a clinical trial to meet the FDA’s requirements for substantial evidence of the efficacy of Bronchitol in patients with cystic fibrosis.

“The outcome of the FDA meeting will allow Pharmaxis to finalise a business review and implement a phased restructuring based around the expected delay to US revenue and the approval paths for Bronchitol in cystic fibrosis and bronchiectasis.  The results of this review will be announced by the end of May 2013.”

Pharmaceutical company Pharmaxis (ASX: PXS) today announced its Phase 3 clinical trial (B305) assessing the effectiveness of Bronchitol® in people with bronchiectasis had not met the trial’s primary endpoint of demonstrating a significant difference in the rates of defined pulmonary exacerbations in patients treated over a 12 month period.

Top line results of the double blind, placebo controlled, randomised trial showed an eight (8) per cent reduction in exacerbation rates among patients treated with Bronchitol compared with control which was not statistically significant.

The positive trend in the primary endpoint was supported by a number of statistically significant secondary endpoints. These included a delay in the time to a first exacerbation, reduced days on antibiotics and improved quality of life.

The trial results show Bronchitol has an acceptable safety profile in the patient population studied with no overall difference in the numbers of patients experiencing adverse events or serious adverse events in the Bronchitol and control groups.

Pharmaxis Ltd (PXS) expects to complete its analysis and announce the results of its Phase III clinical trial of Bronchitol in patients with bronchiectasis prior to opening of the market tomorrow, 24 April 2013.  The announcement will have the effect of lifting the current trading halt over the company’s shares. 

The company will hold an investor teleconference at 9.30am tomorrow to discuss the results.

Telephone access (toll free):

• Australia: 1800 059 809 or 1800 606 599
• USA/Canada:  1855 881 1339
• UK: 0800 051 8245
• NZ: 0800 453 055

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Online access: http://services.choruscall.com/links/pharmaxis130424.html

A recording of the conference will be available on the Pharmaxis website home page approximately 3 hours after the call.