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Pharmaceutical company Pharmaxis (ASX: PXS) is pleased to announce it has received Marketing Authorisation for Bronchitol from the European Commission. The licence allows the new cystic fibrosis treatment to be made available to patients aged 18 and over throughout the European Union.

Pharmaxis CEO Dr Alan Robertson said, “This is a very significant event, which means that patients living with cystic fibrosis in Europe will now be able to receive the proven clinical benefits of Bronchitol.”

Bronchitol will be made available across 29 European countries at an average ex-factory price of approximately 20-25 Euros per day.  CF patients in Germany and the UK, where there is no requirement for pricing and reimbursement approval before launch, will be first to benefit from Bronchitol. These two countries make up 40% of the European market by value. Pharmaxis expects stock to be available for sale in Europe by mid May ahead of the official launch of the product, which will take place at the European Cystic Fibrosis Symposium in Dublin from 6th - 9th June 2012.

Pharmaxis Ltd today announced the completion of an exploratory Phase IIa trial with ASM8 in patients with allergic asthma.

The trial was a double-blind, randomized, controlled, 3-way crossover study to evaluate the efficacy and safety of 14-day inhaled ASM8 in subjects with asthma.  The primary outcome measure was the effect of ASM8 on allergen induced Late Allergic Response 3-7 hours post-allergen challenge.  16 subjects participated in the trial and each received two doses of ASM8 (3mg or 7.8mg) or control at different times, once per day in a randomized, cross over fashion.

Bronchoconstriction (as measured by change in FEV1) during the late phase of the allergen challenge response was reduced by 44% (p<0.05) when dosed with3mg and by 41% (p<0.01) when dosed with 7.8mg ASM8, as assessed by the change in area under the curve, 3-7 hours post challenge compared to screening.  This is consistent with a previously reported trial that reduced the Late Allergen Response by 59% (p<0.005) following 4 day dosing with 8mg ASM8.  However, in the current trial, the control also reduced the Late Allergen Response by 44% (p<0.005), 3-7 hours post dose, meaning there was no difference between doses.

The statistically significant effect of the response when subjects were treated with vehicle is indicative of a drug carryover effect that can result in studies of a cross over design.