SYDNEY, Australia, Aug. 28 /Xinhua-PRNewswire-FirstCall/ -- Specialist pharmaceutical company Pharmaxis Ltd is pleased to announce that the U.S. Aridol Phase III clinical trial in subjects with suspected asthma has finished recruitment. The trial was conducted in over 400 subjects in 30 hospitals throughout the U.S.
The trial compared Aridol with acknowledged methods for diagnosing airway responsiveness in subjects suspected of having asthma. Its design was based on discussions with the U.S. Food and Drug Administration (FDA). Initial data from the study, comparing the sensitivity and specificity of Aridol (mannitol) to identify exercise-induced bronchoconstriction, are expected to be available during the fourth quarter of this year.
Alan Robertson, Pharmaxis chief executive officer said: ‘A major impediment to better disease control in asthma is a lack of objective symptom measurements which often confounds accurate diagnosis. This large asthma trial supplements our earlier successful 650 patient study outside of the U.S. and the level of support amongst the U.S. respiratory physicians and their patients has been very encouraging. I expect this study to be an important part of our marketing application for Aridol with the FDA.’
The economic opportunity for a reliable, quick and objective lung function test to measure asthma severity is significant. Based on independent market research, the annual addressable market for Aridol in the U.S. and Europe includes the existing 400,000 bronchial challenge tests performed yearly, 2 million new tests for assisting the diagnosis of asthma and 16 million new tests performed by pulmonary specialists and primary care physicians for assisting the management of asthma.
Asthma affects more than 50 million people in the western world, and is one of the most common reasons for hospital admission and emergency room care.
To find out more about Pharmaxis, go to http://www.pharmaxis.com.au . For more about the trial, go to p2, http://www.pharmaxis.com.au/library/205_12_14_A305_first_patient.pdf . For more About Aridol go to http://www.pharmaxis.com.au/products/aridol/aridol_home.cfm .
Forward-Looking Statements
The statements contained in this press 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 press 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 press 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, Pharmaxis Ltd Tel: +61-2-9454-7200 Fax: +61-2-9451-3622 Released through: United States: Brandon Lewis Trout Group Tel: +1-212-477-9007 Email: blewis@troutgroup.com Australia: Ashley Rambukwella Financial & Corporate Relations Pty Ltd. Tel: +61-2-8264-1004 / +61-407-231-282 Email: a.rambukwella@fcr.com.au
Pharmaxis Ltd
CONTACT: Alan Robertson of Pharmaxis, +61-2-9454-7200 or fax,+61-2-9451-3622; or Brandon Lewis of Trout Group for Pharmaxis,+1-212-477-9007, or blewis@troutgroup.com; or Ashley Rambukwella ofFinancial & Corporate Relations Pty Ltd. for Pharmaxis, +61-2-8264-1004, or+61-407-231-282, or a.rambukwella@fcr.com.au
