ELTVILLE, Germany, April 27, 2012 /PRNewswire/ --
Pharmaceutical company Pharmaxis 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 for patients aged 18 and above as an add-on therapy to the best standard of care in 29 European countries.
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."
CF patients in Germany and the UK, where there is less 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 June 1st ahead of the official launch of the product, which will take place at the European Cystic Fibrosis Conference in Dublin from 6th - 9th June 2012.
Bronchitol has been developed to help clear the airways of people with the world's most common, life limiting genetic disease, cystic fibrosis. In two large Phase 3 clinical trials, Bronchitol improved mucus clearance, improved lung function and reduced infectious episodes compared to control when patients were treated for 6 months.
Dr Robertson said, "We have built considerable momentum around Bronchitol in recent months with the German and UK sales teams fully recruited and trained."
"Pharmaxis has now secured three drug approvals in the world's largest pharmaceutical markets: the lung function test Aridol in Europe and the US and now approval for Bronchitol in Europe and Australia. This is a credit not only to the company but also the investigators and patients throughout the world who have taken part in our clinical programs," Dr Robertson said.