Pharmaxis' Aridol Authorised for Sale in Germany
19 Maggio 2008 - 4:13AM
PR Newswire (US)
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: Released Through: Australia: Virginia
Nicholls Tel: +61-417-610-824 Email United States: Brandon Lewis
Trout Group Tel: +1-646-378-2915 Email: DATASOURCE: Pharmaxis Ltd
CONTACT: Alan Robertson, Chief Executive Officer Of Pharmaxis,
+61-2-9454-7200, Web Site: http://www.pharmaxis.com.au/
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