SourceDrug developer Pharmaxis shares are in a trading halt...

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Drug developer Pharmaxis shares are in a trading halt while it evaluates results from a late-stage trial of its drug to treat bronchiectasis.

Bronchiectasis is a condition in which damage to the airways causes them to dilate, lose their tone and become scarred.

The airways consequently lose their ability to clear mucous, leading to the growth of bacteria and serious lung infections.

Eventually, this can lead to respiratory failure.

Pharmaxis on Monday said it had received the results for its Phase III trial of Bronchitol, also referred to as B305.

"B305 is a large trial, and the results require detailed analysis," Pharmaxis said in a statement.

"Pharmaxis requests an immediate trading halt of its securities pending the analysis and announcement of the results of the trial."

The trading halt will last until the start of trading on the Australian Securities Exchange on April 24 or until the company makes an announcement to the market.

Pharmaxis last traded at 31.5 cents.

The company completed a 52-week international trial assessing the effectiveness of Bronchitol in people with non-cystic fibrosis bronchiectasis in early March.

The trial recruited 485 participants and was conducted across 83 hospitals in the United States, Europe, South America and Australia.

In mid-March, the US Food and Drug Administration (FDA) declined approval for the marketing of Bronchitol in the US to treat cystic fibrosis.

The FDA recommended that Pharmaxis conduct an additional clinical trial to obtain approval for Bronchitol to treat the condition.

Announcement from March 3rd ...

ASX Media Release 8 March 2013
PHARMAXIS ANNOUNCES MILESTONE IN PHASE 3 TRIAL FOR BRONCHIECTASIS

Specialty pharmaceutical company Pharmaxis (ASX: PXS) today announced formal completion of a 52
week, Phase 3 international trial assessing the effectiveness of Bronchitol® in people with
bronchiectasis. The last participant has completed the final clinical visit in the trial which began in
October 2009.

The double blind, controlled, randomised trial recruited 485 participants and was conducted across 83 hospitals in the U.S., Europe, South America and Australia. The purpose of the trial was to examine the efficacy and safety of 52 weeks treatment with Bronchitol in subjects with non-cystic fibrosis bronchiectasis.

Pharmaxis Chief Executive Officer, Alan Robertson said: “This was a complex trial that collected a vast
amount of data over a long period and has already provided great insights into this under researched patient population. We are grateful to the volunteers in the trial and are hopeful that the data will allow us to make the benefits of Bronchitol available to a wider group of people.”

The primary endpoint of the trial was to show a significant difference in the rates of graded pulmonary
exacerbations, in patients with bronchiectasis treated with Bronchitol compared to control. Secondary endpoints included quality of life, sputum weight and lung function as measured by spirometry.

The headline results of the trial will be available during the second quarter of 2013 following data review and statistical analysis.

Approximately 600,000 people in the major pharmaceutical markets have bronchiectasis and no products have been approved to assist with mucus clearance. An exacerbation is a serious life threatening complication for patients with bronchiectasis and often leads to hospitalisation.

Moreover, an exacerbation leads to increased damage to the lungs and accelerates loss of lung function.

A positive outcome from the trial may form the basis for an extension to the existing marketing approvals for Bronchitol in the European Union and Australia where patients seeking treatment are estimated at 210,000 and 18,000 respectively.