Pharmaceutical company Pharmaxis Ltd
(ASX:PXS) says it has submitted an application to the Therapeutic Goods Administration to market Bronchitol in Australia for the treatment of cystic fibrosis.
The company filed an application to market Bronchitol with the European Medicines Agency in October.
Both of these applications are based on successful international Phase 3 clinical trial reported in May with headline results showing a 6.5% improvement in the lung function of patients treated with Bronchitol.
CEO Dr Alan Robertson says this has been an important year for Pharmaxis and he is delighted that 2009 is ending with another step towards bringing Bronchitol to the cystic fibrosis community in Australia.
The TGA will advise by mid February 2010 if the marketing application is accepted for evaluation, with a final decision expected in the first half of 2011.
Pharmaxis posted a loss of $35.17 million for fiscal 2009.
