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.

28th May 13

Pharmaxis Announces Outcome of Business Review

Pharmaceutical company Pharmaxis (ASX:PXS) today announced a revised business plan that delivers significant reductions in expenses and increases the focus on partnering strategies to grow the value of the Company’s assets and reposition it for the future in the global respiratory drug market.

Pharmaxis will reduce the Company’s March 2013 annualised cash cost base by approximately 29% and the annualised cash loss by approximately 37%. This includes extensive staff reductions and consolidation of manufacturing facilities with some cost cutting measures already being implemented.

The Company will seek partnership opportunities for Bronchitol in the US for cystic fibrosis (CF) and globally for bronchiectasis while retaining a direct commercial interest in Bronchitol in Europe and other approved and reimbursed markets.

In addition, Pharmaxis has initiated discussions with various third parties to secure funding for all or some of the Company’s innovative pipeline of early stage compounds.

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22nd May 13

Pharmaxis Appoints Bronchitol Distributor for Poland

Pharmaceutical company Pharmaxis (ASX:PXS) is pleased to announce that it has appointed PharmaSwiss SA, a division of Valeant Pharmaceuticals International, Inc, as distributor for Bronchitol® in Poland and ten other Eastern European countries.

Headquartered in Switzerland, PharmaSwiss operates in 17 Central and Eastern European countries with regional expertise across regulatory affairs, compliance, sales, marketing and distribution.

Pharmaxis CEO Mr Gary Phillips said, “Pharmaxis is moving swiftly in executing plans for the continued commercialisation of Bronchitol. With more than 6,000 cystic fibrosis patients, Poland is a solid market where our European Union approval applies. PharmaSwiss is well equipped to support us with a firm presence in Poland and other Eastern European countries.”

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21st May 13

Pharmaxis Agrees Key Cystic Fibrosis Trial Parameters with FDA on Bronchitol

Pharmaceutical company Pharmaxis (ASX: PXS) today announced it had concluded a productive end of review meeting with the US Food and Drug Administration (FDA) which has provided the Company with a clear outline of the clinical trial required to gain approval for Bronchitol® (mannitol) to treat cystic fibrosis (CF) in the United States.

The Type A meeting discussed the remaining clinical work required to show substantial evidence of efficacy in patients with cystic fibrosis.  The FDA and Pharmaxis agreed that the clearest and most expeditious regulatory path forward is to conduct a further single pivotal trial in adults aged 18 years and over.  It was also agreed that the trial should have a very similar design to the two large scale clinical trials already undertaken by Pharmaxis (CF 301 and CF 302). It will be of six months duration with improvement in lung function as measured by a change in Forced Expiratory Volume in 1 second (FEV1) as its primary endpoint.

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