Pharmaxis close to EU approval for Bronchitol

Pharmaxis (ASX:PXS) expects to receive approval from the European Commission next month to market its Bronchitol inhaler in Europe as a cystic fibrosis treatment.

The company has received notification from the EC that processing of its marketing authorisation application for the drug is nearing completion.

An authorisation would allow the company to sell Bronchitol in 29 European countries.

The company plans to launch Bronchitol in the market in the second quarter, starting with Germany and the UK, which together make up 40% of the EU market by value.

Pharmaxis CEO Dr Alan Robertson said the company had completed the preparations for a commercial launch in Europe.

“Sales teams have been fully recruited and trained in Germany and the UK and stock will be in markets within weeks of receipt of the Marketing Authorisation,” he said.

Europe's Committee for Medicinal Products for Human Use (CHMP) recommended that Bronchitol should receive EU marketing approval in October last year.

Earlier this week, Pharmaxis revealed that Australia's Pharmaceutical Benefits Advisory Committee has recommended Bronchitol for inclusion in the Pharmaceutical Benefits Scheme.

Pharmaxis will now meet with the Australian Pharmaceutical Benefits Pricing Authority to negotiate reimbursement terms.

Bronchitol is a proprietary formulation of mannitol designed to hydrate the lungs and help restore normal lung clearance of mucus.

The company received marketing approval for the product in Australia in February last year, and it has been granted orphan drug designation in both the US and the EU.

Pharmaxis is also currently preparing for a New Drug Application (NDA) with the US FDA for Bronchitol, to be filed in the second quarter.

Pharmaxis (ASX:PXS) shares grew 6.87% on Friday to $1.245 after the company announced the notification. The shares have had a strong month of trading, having started March at $1.060.