Pharmaxis debuts Bronchitol in EU

Pharmaxis (ASX:PXS) has used this week's European Cystic Fibrosis Meeting in Ireland to launch its flagship Bronchitol spray in the UK and Germany.

Bronchitol is designed to reduce the amount of mucus build-up in the lungs of patients with respiratory conditions. It consists of a proprietary formulation of mannitol, delivered though an inhaler.

To coincide with the launch, the company presented phase III trial data indicating that the product can be effective at reducing exacerbations in patients with cystic fibrosis.

The data from two 2009 trials shows that exacerbation incidences decreased by 29% in the overall population, by 24% in adults, and by 59% in adult patients who had also shown an increase in lung function on bronchitol.

Sputum weight in adult patients was also increased at both six and 14 weeks, and improvements in lung function were sustained out to 12 months.

Principal investigator Dr Moira Atken said the results of the trial are encouraging. “There remains a significant need for new treatments in cystic fibrosis and the results [suggest Bronchitol] is a very useful drug,” she said.

Pharmaxis gaining marketing approval for Bronchitol throughout the EU in April.

The product is making its debut in the UK and Germany as there is no requirement to receive pricing and reimbursement approval before launching in these markets.

Earlier this month, the company published the retail prices for the product in the two markets - £16.55 ($25.99) per day in the UK, and €35.65 ($45.28) per day in Germany. The UK Department of Health has provided notification that the UK price is acceptable.

But the UK National Institute for Health and Clinical Excellence (NICE) has issued a preliminary opinion that Bronchitol cannot yet be considered a cost-effective use of NHS resources.

Pharmaxis CEO Dr Alan Robertson announced the NICE decision on June 1, but pointed out that the verdict is not final, and that no cystic fibrosis drugs available in the UK other than Bronchitol have ever been reviewed by the institute.

Pharmaxis (ASX:PXS) shares were trading 0.45% lower at $1.095 as of 3:30pm on Friday.