May 19 2008
Pharmaxis Ltd today announced that it has received national approval to market Aridol in Germany.
Aridol is indicated for measuring airway hyperresponsiveness and has been approved in 14 European countries under the mutual recognition procedure (MRP). The necessary national approvals that follow the MRP have now been received for Denmark, Germany, Ireland, The Netherlands, Portugal, Sweden, and the United Kingdom.
In Germany a total of 660,000 lung function tests are conducted annually, of which approximately 90% are conducted by office-based physicians and the remainder in the major hospitals. To enter the market, Pharmaxis will first negotiate with insurance companies that cover the office-based physician market before launching with a local distributor.
A simple-to-use airways inflammation test, Aridol is a dry powder administered to patients' lungs via a small hand-held inhaler. Doctors can use the results of this test to identify airway hyperresponsiveness -- a hallmark of asthma. Medications can be adjusted according to the severity of the disease. (see overleaf for more details on Aridol)
"We are pleased that Aridol is becoming globally recognised as a useful test for identifying airway hyperresponsiveness," said Pharmaxis CEO Dr Alan Robertson. "With this latest approval, Aridol is on the way to becoming the worldwide standard for detecting sensitive airways in people with conditions such as asthma.
"The Aridol test provides objective information on airway hyperresponsiveness and assists in the diagnosis and assessment of severity of asthma and how much medication should be used."
As well as being included as one of the tests recommended by the International Olympic Committee -- Medical Commission Independent Panel and the World Anti-Doping Agency, Aridol is also included in the GINA Report of Global Strategy for Asthma Management and Prevention, the US Asthma Management Guidelines, the British Guideline on the Management of Asthma and the Australian Asthma Management Handbook.