Investor Centre

Pharmaxis today announced that the Company had presented an oral explanation at the Committee for Medicinal Products for Human Use (CHMP) meeting last week as part of its European Union marketing application for Bronchitol® for the treatment of cystic fibrosis. Following the oral presentation, the members of the CHMP undertook a trend vote intended to show whether they were orientated to vote for, or against, the approval of Bronchitol.The outcome of this trend vote was negative.

While not a final decision, the trend vote indicates that the CHMP's current orientation is not to approve Bronchitol based on the existing application when it meets in June 2011. Pharmaxis considers it unlikely that this position will change before the formal vote is undertaken next month.

The Company is in the process of reviewing its alternatives with respect to the European Union marketing application which are outlined in the attached media release.

Pharmaxis today announced a delay to the listing of Bronchitol on the Australian Pharmaceutical Benefits Scheme (PBS). The company's first submission to list Bronchitol for the treatment of cystic fibrosis was reviewed at the March meeting of the Pharmaceutical Benefits Advisory Committee (PBAC) and was not recommended for inclusion in the PBS, at that time, due to what the PBAC described as “uncertainties in where Bronchitol will fit in clinical practice and consequent difficulties in identifying the right comparator in one clinical setting that leads to uncertain cost-effectiveness."

A resubmission has been prepared to address the issues raised by the PBAC and will be made at the earliest opportunity.