Pharmaxis Ltd Release: Aridol Endorsed In Global And Australian Guidelines

SYDNEY, Australia, Nov. 16 /Xinhua-PRNewswire-FirstCall/ -- Pharmaceutical company Pharmaxis today announced that its first commercial product Aridol has been included in both global and Australian official guidelines for managing asthma.

Aridol’s inclusion in the two influential guidelines: the GINA Report on Global Strategy for Asthma Management and Prevention, and the Australian Asthma Management Handbook, follows extensive independent scientific and clinical review.

Alan Robertson, Pharmaxis CEO, said: “We are delighted that Aridol is recognised and endorsed by both global and Australian experts as a significant addition to the tools available to help asthma patients. Inclusion in both national and international guidelines after exhaustive independent peer review is particularly gratifying, and will accelerate the acceptance of Aridol by physicians worldwide.”

Aridol is recommended in both guidelines as a lung function test that physicians can undertake to diagnose asthma in patients.

The Global Initiative for Asthma (GINA) is a network of individuals, organisations and public health officials who disseminate information about the optimal care of patients with asthma, incorporating the latest research and best clinical practice. This latest report is a direct response by GINA to several recent international surveys which have highlighted that asthma control remains poor. It incorporates updated scientific information (including Aridol) and promotes an approach to asthma management based on asthma control, rather than asthma severity. This is important since Aridol has recently become the first bronchial challenge test to be approved in a European country as an aid to asthma control.

Australia’s new asthma management guidelines were launched yesterday by the Parliamentary Secretary for the Minister for Health and Ageing, Christopher Pyne. Published as the National Asthma Council Australia’s Asthma Management Handbook, the guidelines are the gold standard of practice for asthma management in Australia. They are updated regularly to accommodate changes in asthma management, based on the latest medical evidence and new treatments that become available, as well as reflecting current areas of consumer concern.

-- Pharmaxis Reports Phase III Results for Aridol--

Pharmaceutical company Pharmaxis today announced the results from its US-based Phase III trial for Aridol. The trial was conducted in 30 U.S. centers in more than 500 patients under an FDA approved protocol who were suspected of having asthma but who did not have a firm diagnosis.

In this group with predominantly very mild symptoms, Aridol was able to identify patients with exercise induced bronchoconstriction in 58% of cases (sensitivity). In comparison methacholine, an approved lung function test in the U.S., identified 54% of cases. The difference between the two tests was not statistically significant. Aridol also had similar specificity to methacholine, (66% versus 70% respectively) in subjects without exercise induced bronchoconstriction. In addition Aridol was proven to have an acceptable safety profile.

Based on this study and an earlier Phase III trial that was the basis of the marketing approval in Sweden and Australia, Pharmaxis plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in the second quarter of 2007.

Pharmaxis CEO Dr Alan Robertson said ‘This is the largest study of its kind in this patient group with such mild symptoms. The result underscores that there is no gold standard with which to compare Aridol and it was gratifying to see that it performed as well, or better, than an existing FDA approved test. We plan to discuss the results of the study and the rest of our substantial clinical evidence data base with the FDA at a pre-NDA meeting to be held during Q1 2007. The current study collected a vast amount of data which will be analyzed in the weeks to come and which we expect will further demonstrate the clinical application and usefulness of Aridol. Aridol is the world’s first indirect dry powder challenge test and we expect it to become firmly established in the management of asthma in the future.’

A detailed presentation of the data from the study will be presented at a forthcoming international scientific congress. Aridol is already approved and available in Sweden and Australia, and is currently going through the European regulatory approval system which should see it approved in most of Europe in 2007.

There are more than 52 million asthma sufferers in the developed world. According to the Global Initiative for Asthma (GINA), asthma accounts for 1 in every 250 deaths worldwide and many of the deaths are preventable being due to suboptimal long-term medical care.

To find out more about Pharmaxis, go to http://www.pharmaxis.com.au

For more about the trial details, go to http://www.pharmaxis.com.au/library/2006_11_16_A_305_Report.pdf

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 can not 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.

Released through: United States: Brandon Lewis, Trout Group Tel: +1-212-477-9007 Email: blewis@troutgroup.com Australia: Virginia Nicholls Tel: +61-417-610-824 Email: virginia.nicholls@pharmaxis.com.au CONTACT: Alan Robertson -- Chief Executive Officer Tel: +61-2-9454-7200 Fax: +61-2-9451-3622

Pharmaxis Ltd

CONTACT: Alan Robertson of Pharmaxis, +61-2-9454-7200, or fax+61-2-9451-3622, arobertson@pharmaxis.com.au; Brandon Lewis in US of TroutGroup for Pharmaxis, +1-212-477-9007, blewis@troutgroup.com; VirginiaNicholls in Australia for Pharmaxis, +61-417-610-824

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