Pharmaxis gets marketing nod for Bronchitol in EU

It’s a landmark day for Pharmaxis (ASX:PXS) and for Australian biotechnology, with the Australian born and bred firm receiving marketing approval for Europe for its locally-manufactured Bronchitol cystic fibrosis treatment.

The company has received a license to make Bronchitol available to patients over the age of 18 throughout the European Union.

Pharmaxis has revealed plans to make Bronchitol available across 29 European countries at an average ex-factory price of around €20-€25 ($25-30).

Bronchitol will be officially launched at the European Cystic Fibrosis Symposium in Dublin on June 6-9, but the company expects to make stock available for sale in Europe by mid-May.

It will be distributed in Europe by Aravo Healthcare, under the terms of a three-year agreement between Pharmaxis and Aravo signed last month.

Initially, Pharmaxis plans to launch Bronchitol in Germany and the UK, as there is no requirement to receive pricing and reimbursement approval before launching in these markets.

Pharmaxis CEO Dr Alan Roberton said the partners have been building momentum around the product in Europe in the lead-up to the launch. Sales teams in Germany and the UK were fully recruited as of last month.

Bronchitol is also in line to be listed on the Pharmaceutical Benefits Scheme in Australia, and the company is preparing for a New Drug Application (NDA) with the US FDA.

Earlier this week, Pharmaxis announced the results of a phase IIa trial of ASM8, an asthma treatment which the company also has in development.

While the trial found that ASM8 was safe, data on its efficacy was inconclusive – the control group experienced a similar response in terms of reduction in allergic reaction. The company has speculated that this could be due to an inadequate washout period during the crossover study.

Pharmaxis (ASX:PXS) shares climbed as high as $1.40 in Friday's ASX trading, from a closing price of $1.225, after the EC approval was announced. As of 3pm, the shares were trading 6.12% higher at $1.300.