Investor Centre

Pharmaxis 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.

Pharmaxis made an oral presentation to last week's meeting of the European Committee for Medicinal Products for Human Use (CHMP). Subsequent to the meeting the CHMP has now provided the company with its outstanding issues and advised that the review timetable will conclude in Q2 2011.

“We are pleased with the ongoing discussions with the CHMP and believe we are in a good position to provide our response to their outstanding issues in a timely manner", said Dr Alan Robertson, Chief Executive Officer of Pharmaxis.

Bronchitol has been the subject of two international Phase 3 clinical trials and is the only new product in registration to treat cystic fibrosis.

Pharmaxis today announced that the review of the European Marketing Application will not conclude as previously advised during Q4 2010.

At the Committee for Medicinal Products for Human Use (CHMP) meeting last week, it was agreed, that Bronchitol would be the subject of an oral explanation at the January meeting. Therefore, the review is now expected to conclude during Q1 2011.