Investor Centre

Pharmaceutical company Pharmaxis (ASX: PXS) today announced it had received a complete response letter from the Food and Drug Administration (FDA) confirming Bronchitol® cannot yet be approved for marketing for the treatment of cystic fibrosis in the United States.

The FDA has concluded its review of the Bronchitol New Drug Application (NDA) and recommended Pharmaxis conduct an additional clinical trial to obtain an approval for Bronchitol.

The Pharmaxis Board has today appointed Mr Gary Phillips to the position of Chief Executive Officer with immediate effect.  Mr Phillips has served as the Company’s Chief Operating Officer for 5 years having started with Pharmaxis when it listed on the Australian Securities Exchange in 2003.

Dr Alan Robertson steps down and will leave the Company after 13 years of service as the founding Chief Executive Officer.  He has agreed to assist Pharmaxis in a consulting capacity to help the Company generate value from its pipeline of early stage assets.

Specialty pharmaceutical company Pharmaxis (ASX: PXS) today announced formal completion of a 52 week, Phase 3 international trial assessing the effectiveness of Bronchitol®in people with bronchiectasis. The last participant has completed the final clinical visit in the trial which began in October 2009.