SYDNEY, Australia, March 23 /Xinhua-PRNewswire-FirstCall/ -- Specialist pharmaceutical company Pharmaxis Ltd announced today that the Therapeutic Goods Administration (TGA) has approved its first product, Aridol(TM), for commercial sale in Australia. This represents a rare example of an Australian human therapeutic product developed in Australia from concept to commercialisation.
Aridol is designed to identify patients with active asthma and provide information on the severity of the disease and the effectiveness of their current treatment. More than 2 million people in Australia and 52 million people worldwide live with the disease. Currently, there is no registered, objective test to measure inflammation and hyper-responsiveness in the airways -- the symptoms of active asthma. Aridol fills this gap.
Alan Robertson, Pharmaxis chief executive officer said: “This is a significant milestone for Pharmaxis, and demonstrates the capability and potential of the company. The assistance and advice of the TGA has been very helpful as we have moved Aridol through its development and evaluation to final commercialisation. We have full commercial rights to Aridol, and we can now set about building a profitable Aridol business.
“Aridol offers better health outcomes for people with asthma and the product launch preparations are under way. Our marketing program will initially make Aridol available to respiratory specialists and laboratories. Aridol was conceived over ten years ago, and today’s decision represents the culmination of significant effort by many people over many years.”
Pharmaxis will market Aridol directly in Australia, and is negotiating European marketing agreements with specialised companies that are committed to improving standards in respiratory care, two of which are already in place.
To find out more about Pharmaxis, go to http://www.pharmaxis.com.au .
About Pharmaxis
Pharmaxis (ACN 082 811 630) is a specialist pharmaceutical company involved in the research, development and commercialization of therapeutic products for chronic respiratory and autoimmune diseases. Its development pipeline of products include Aridol(TM) for the management of asthma, Bronchitol(TM) for cystic fibrosis and chronic obstructive pulmonary disease (COPD) and PXS64 for the treatment of multiple sclerosis.
Founded in 1998, Pharmaxis was listed on the Australian Stock Exchange in November 2003 (symbol PXS), and on NASDAQ (symbol PXSL) in August 2005. The company is headquartered in Sydney at its TGA-approved manufacturing facilities. For more information about Pharmaxis, go to www.pharmaxis.com.au or contact Jane Sugden, Investor Relations +61 2 9454 7230.
About Aridol
Asthma is among the top 10 most commonly cited reasons for consulting a physician. Yet physicians currently rely upon older tests that are often inaccurate and cumbersome to assess airway inflammation in patients with asthma.
The lung function test, Aridol, developed by Australian researchers and Pharmaxis Ltd, will help doctors more accurately determine the severity of a patient’s disease and allow prescription of the right amount of medication.
The simple 15 minute test uses a patented formulation of mannitol manufactured into a respirable dry powder. The test requires the patient to inhale increasing doses of Aridol, which causes the airways to narrow and contract. The changes in the airways are simply detected by measuring the amount of air a person can exhale. 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.
Doctors can use the results of this test to measure the severity of a patient’s asthma allowing better control of the disease.
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 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 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 or +61-407-231-282 Email: a.rambukwella@fcr.com.au
Pharmaxis Ltd
CONTACT: Alan Robertson of Pharmaxis, +61-2-9454-7202, or fax,+61-2-9451-3622; or Brandon Lewis of Trout Group for Pharmaxis,+1-212-477-9007, or blewis@troutgroup.com; Ashley Rambukwella of Financial& Corporate Relations Pty Ltd. for Pharmaxis, +61-2-8264-1004, or+61-407-231-282, or a.rambukwella@fcr.com.au
Web site: http://www.pharmaxis.com.au/
