SYDNEY, Australia, June 11 Pharmaceuticalcompany Pharmaxis (ASX: PXS; Nasdaq: PXSL) today announced that the 12 monthPhase III clinical trial evaluating the safety of Bronchitol in 100 subjectswith 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 Bronchitolimproved quality of life and mucus clearance. The objective of the open labelextension is to determine the adverse event profile of Bronchitol followingprolonged use.
Following statistical analysis, the results from this second phase of thetrial 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 forBronchitol next quarter.
''We are receiving strong demand to continue treatment after participationin the trial has concluded and, where possible, we make this available.''
Bronchitol is being developed as a twice daily inhalation therapy forpeople with the incurable lung condition bronchiectasis.
It is estimated that more than 600,000 people in the major pharmaceuticalmarkets suffer from bronchiectasis and Pharmaxis expects Bronchitol to be thefirst targeted medication for this patient group in 20 years, addressing animportant medical need. Total U.S. medical care expenditure is US$13,000 perbronchiectasis patient, double that of patients without the disorder; and anincreased overall cost to the US health system of US$630 million.
Bronchiectasis is an incurable, degenerative and chronic lung conditionthat makes breathing difficult through excessive mucus build up in the lungs.
The statements contained in this media release that are not purelyhistorical are forward-looking statements within the meaning of Section 21E ofthe Securities Exchange Act of 1934, as amended. Forward-looking statements inthis media release include statements regarding our expectations, beliefs,hopes, goals, intentions, initiatives or strategies, including statementsregarding the potential for Aridol and/or Bronchitol. All forward-lookingstatements included in this media release are based upon information availableto us as of the date hereof, and we assume no obligation to update any suchforward-looking statement as a result of new information, future events orotherwise. We cannot guarantee that any product candidate will receive FDA orother regulatory approval or that we will seek any such approval. Factors thatcould cause or contribute to such differences include, but are not limited to,factors discussed in the "Risk Factors and Other Uncertainties" section of ourForm 20-F lodged with the U.S. Securities and Exchange Commission.CONTACT: Alan Robertson Chief Executive Officer Tel: +61-2-9454-7200 Email: [email protected]
Released through: Australia: Virginia Nicholls Tel: +61-417-610-824 Email: [email protected]
United States: Brandon Lewis, Trout Group Tel: +1-646-378-2915 Email: [email protected]
Australia: Felicity Moffatt Tel: +61-418-677-701 Email: [email protected]
SOURCE Pharmaxis Ltd