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.

27th Jun 11

EU Marketing Authorisation Application Review of Bronchitol

Pharmaxis announced today that the Committee for Medicinal Products for Human Use (CHMP) have, at this point, refused the marketing authorisation for Bronchitol® for the treatment of cystic fibrosis and have now provided the reasoning behind reaching this opinion.This opinion is consistent with the trend vote taken by the CHMP at its May meeting, and advised publically by Pharmaxis on 25 May 2011.

The major concern of the CHMP that lead to the refusal was their view that the effectiveness and benefit of Bronchitol had not been established. In particular, that it was not clear to the CHMP that the improvement in lung function would be sufficient to improve the patient's condition and that the extent of the improvement was difficult for them to ascertain since the results of the studies were, in their view, inconsistent across the different age groups.


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24th Jun 11

European CHMP Confirms Negative Opinion on Bronchotol for Cystic Fibrosis

Pharmaxis today announced it has been advised by the European Medicines Agency that the June meeting of the Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion in relation to the Company's marketing application for Bronchitol for cystic fibrosis.This confirms the negative trend vote, taken by the CHMP at its May meeting that was advised by Pharmaxis on 25 May 2011.

The Company expects to receive further information and will update the market as appropriate.


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