Investor Centre

Pharmaceutical company Pharmaxis (ASX:PXS) is pleased to announce that it has appointed United Medical Ltda as exclusive distributor and sales representative for Bronchitol® in Brazil.

Under the terms of the agreement United Medical has responsibility for sales and marketing, pricing, warehousing, distribution and patient support.  United will shortly file a marketing approval application with the Brazilian regulatory agency (ANVISA) based on Bronchitol’s Australian approval, a process which is expected to take up to 18 months.  Pharmaxis will receive milestone payments ahead of Bronchitol’s approval in Brazil.

United Medical is a well-established healthcare company based in São Paulo. It partners with leading global pharmaceutical companies and its sales team has worked closely with the cystic fibrosis medical community in Brazil since 1999.

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.