Pharmaxis Long-Term Safety Study of Bronchitol Completes
12 Giugno 2008 - 1:47AM
PR Newswire (US)
SYDNEY, Australia, June 11 /Xinhua-PRNewswire-FirstCall/ --
Pharmaceutical company Pharmaxis (ASX:PXS)(NASDAQ:PXSL) today
announced that the 12 month Phase III clinical trial evaluating the
safety of Bronchitol in 100 subjects with bronchiectasis has
completed. This 12-month treatment period was an open label
extension to a three- month efficacy trial which has already
reported, showing that Bronchitol improved quality of life and
mucus clearance. The objective of the open label extension is to
determine the adverse event profile of Bronchitol following
prolonged use. Following statistical analysis, the results from
this second phase of the trial will be reported in July 2008.
Pharmaxis CEO Alan Robertson said following receipt of the study
report, Pharmaxis intends filing its first marketing application in
Australia for Bronchitol next quarter. 'We are receiving strong
demand to continue treatment after participation in the trial has
concluded and, where possible, we make this available.' Bronchitol
is being developed as a twice daily inhalation therapy for people
with the incurable lung condition bronchiectasis. It is estimated
that more than 600,000 people in the major pharmaceutical markets
suffer from bronchiectasis and Pharmaxis expects Bronchitol to be
the first targeted medication for this patient group in 20 years,
addressing an important medical need. Total U.S. medical care
expenditure is US$13,000 per bronchiectasis patient, double that of
patients without the disorder; and an increased overall cost to the
US health system of US$630 million. Bronchiectasis is an incurable,
degenerative and chronic lung condition that makes breathing
difficult through excessive mucus build up in the lungs.
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. 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: Australia: Felicity Moffatt Tel:
+61-418-677-701 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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