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Wednesday, February 9, 2011

Australian Approval for Pharmaxis

08 February 2011


Pharmaceutical company Pharmaxis (ASX: PXS) today announced that the Australian Therapeutic Goods Administration (TGA) has approved Bronchitol (inhaled dry powder mannitol) for marketing in Australia for the treatment of cystic fibrosis and it is now to be included in the Australian Register of Therapeutic Goods (ARTG).

Bronchitol has been approved for the treatment of cystic fibrosis (CF) in both adult and paediatric patients aged over six years as either an add-on therapy to dornase alfa or in patients intolerant of, or inadequately responsive to, dornase alfa.

Mr Terry Stewart, CEO of CF Australia, said: "We welcome the approval of Bronchitol and congratulate Pharmaxis on its commitment to helping patients and in getting a long awaited new treatment to this point. There is a great need for new medicines for people with CF. We must not forget that this is a genetic condition; people have cystic fibrosis from their first breath, so anything new that can improve patients' way of living, their quality of life and potentially their length of life is a wonderful step forward."
Dr Alan Robertson, Pharmaxis Chief Executive Officer, said: "The TGA's decision is the first approval for Bronchitol anywhere in the world and is an historic milestone for the company. It is fitting for a product that has been discovered and developed in Australia to be made available first to Australian patients. We are extremely pleased to have concluded the regulatory review process for Bronchitol with the TGA, one of the world's leading regulatory bodies. This approval is a testament to the hard work of many people in Pharmaxis and those in the CF community worldwide who have assisted in the clinical development of Bronchitol."

Bronchitol has been the subject of two pivotal clinical trials in cystic fibrosis in over 600 people involving 93 hospitals around the world. In April 2009 Bronchitol was awarded Orphan Drug designation in Australia for the treatment of patients with cystic fibrosis to improve lung function and reduce exacerbations.

Bronchitol has received Orphan Drug Designation and fast track status from the US Food and Drug Administration and Orphan Drug Designation from the European Medicines Agency.


SOURCE: Pharmaxis Ltd, Sydney, Australia
CONTACT: Alan Robertson - Chief Executive Officer
Ph: +61 2 9454 7200 or email alan.robertson@pharmaxis.com.au
Felicity Moffatt, phone +61 418 677 701 or email felicity.moffatt@pharmaxis.com.au

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