Pharmaxis' Aridol Authorised for Sale in Germany
SYDNEY, Australia, May 18 /Xinhua-PRnewswire-Firstcall/ -- Specialist
Pharmaceutical Company Pharmaxis Ltd (ASX: PXS; Nasdaq: PXSL) 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. To find out more about Pharmaxis go to
http://www.pharmaxis.com.au .
About Aridol
Aridol is the first and only approved Europe-wide lung function test and
the world's first approved indirect challenge test for asthma. The Aridol lung
function test, developed by Australian researchers and Pharmaxis, helps
doctors more accurately determine the severity of a patient's airways
inflammation -- a hallmark of asthma -- and allow prescription of the right
amount of medication. The simple 15-25 minute test uses powdered mannitol,
which the patient inhales in increasing doses. In asthmatic patients, this
causes the airways to narrow and contract, which is detected by measuring the
amount of air a person can exhale in one second. The smaller the dose required
to cause contraction, the more severe the patient's asthma. People without
airway inflammation do not respond to an Aridol challenge test. Asthma affects
52 million people worldwide, many of whom may be receiving inappropriate
medication because of the absence of an objective test -- until now. Clinical
trial results suggest that 25% of asthmatic patients are being treated with
sub-optimal dosages of asthma medication, and up to 17% could reduce their
medication without adverse effects.
Forward-Looking Statements
The statements contained in this media release that are not purely
historical are forward-looking statements within the meaning of Section 21E of
the Securities Exchange Act of 1934, as amended. Forward-looking statements in
this media release include statements regarding our expectations, beliefs,
hopes, goals, intentions, initiatives or strategies, including statements
regarding the potential for Aridol and/or Bronchitol. All forward-looking
statements included in this media release are based upon information available
to us as of the date hereof, and we assume no obligation to update any such
forward-looking statement as a result of new information, future events or
otherwise. We cannot guarantee that any product candidate will receive FDA or
other regulatory approval or that we will seek any such approval. Factors that
could cause or contribute to such differences include, but are not limited to,
factors discussed in the "Risk Factors and Other Uncertainties" section of our
Form 20-F lodged with the U.S. Securities and Exchange Commission.
For More Information, Please Contact:
Alan Robertson
Chief Executive Officer
Tel: +61-2-9454-7200
Email: Alan.Robertson@Pharmaxis.Com.Au
Released Through:
Australia:
Virginia Nicholls
Tel: +61-417-610-824
Email Virginia.Nicholls@Pharmaxis.Com.Au
United States:
Brandon Lewis
Trout Group
Tel: +1-646-378-2915
Email: Blewis@Troutgroup.Com
SOURCE Pharmaxis Ltd
Alan Robertson, Chief Executive Officer Of Pharmaxis, +61-2-9454-7200,
Alan.Robertson@Pharmaxis.Com.Au
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