For the latest media releases and news about Pharmaxis Ltd, please select from the following articles. Material news announcements made by Pharmaxis are first filed with the Australian Securities Exchange (ASX) and are also available on the ASX website.
Phase 3 Clinical Trial in Bronchiectasis (B305) Fails Primary Endpoint; Meets Key Secondary Endpoints on Efficacy and Safety
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.
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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
Telephone access (metered): +61 2 9008 9005
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.
Pharmaceutical company Pharmaxis (ASX:PXS) is pleased to announce that it has appointed United Medical Ltda as exclusive distributor and sales representative for Bronchitol® in Brazil.
Under the terms of the agreement United Medical has responsibility for sales and marketing, pricing, warehousing, distribution and patient support. United will shortly file a marketing approval application with the Brazilian regulatory agency (ANVISA) based on Bronchitol’s Australian approval, a process which is expected to take up to 18 months. Pharmaxis will receive milestone payments ahead of Bronchitol’s approval in Brazil.
United Medical is a well-established healthcare company based in São Paulo. It partners with leading global pharmaceutical companies and its sales team has worked closely with the cystic fibrosis medical community in Brazil since 1999.
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