Pharmaxis earns regulatory thumbs-up for Aridol

The Australian Drug Evaluation Committee has recommended to the TGA that Sydney-based drug developer Pharmaxis' (ASX:PXS) first product, the asthma diagnostic and treatment management tool Aridol, be registered for sale in Australia.

"It's a good one, 10 years in the making, and I'm pleased that the project has reached this point," said Pharmaxis CEO Alan Robertson. "This is the key event in the process to marketing the product -- this is a positive step and it should take about a month for the TGA to ratify."

Robertson said Pharmaxis already had a sales and marketing manager, and would hire a sales team. The company said about 2 million Australians -- 10 per cent of the population -- had clinical symptoms of asthma, and worldwide more than 52 million people are affected. Pharmaxis puts annual revenue potential of Aridol as a management tool for asthma at more than AUD$250 million. Twenty per cent of asthma patients are overtreated and over-diagnosed, while 25 per cent are not well controlled, the company claims.

"Aridol is a home-grown discovery which has been totally developed in Australia, by an Australian company, from concept to marketing," Robertson said. "It is a real sign of the times and shows that things are changing in Australia."

Swedish decision

Pharmaxis is also waiting on word from the Swedish Medical Products Agency (MPA) following its application for Aridol registration in May 2005.

The company enrolled the first patients in a US phase III trial of Aridol in December 2005 and intends to file for authorisation to market Aridol with the FDA later this year.

"It has been recruiting very steadily," Robertson said. "We hope to have data from that trial in the middle of the year and then be in a position to file a NDA [new drug application] shortly after -- it is a very busy time for us."

Robertson said Pharmaxis also expected to start phase III clinical trials for its Bronchitol product in bronchiectasis in the first quarter of 2006, and Bronchitol in cystic fibrosis in mid-2006.

"We committed to undertaking three phase III trials this year," he said. "One phase III trial is a significant effort -- to embark on three is three times the fun."

Simple procedure

Aridol is designed to identify patients with active airway inflammation, such as occurs in asthma, provide information on the severity of their disease and help monitor the effectiveness of their current treatment.

The Aridol test is said to be a simple, 15-minute procedure, which uses a patented formulation of mannitol processed into a respirable powder. The test requires the patient to inhale increasing doses of Aridol, which causes the airways to narrow and contract that is detected by measuring the amount of air a person can exhale in one second. The smaller the dose required to cause contraction, the more severe the patient's asthma diagnosis. People without airway inflammation do not respond to an Aridol challenge test.

The Australian Drug Evaluation Committee is appointed by the federal health minister to advise on the suitability of drugs for marketing in Australia. The committee includes physicians, pharmacologists, toxicologists and pharmacists and provides independent, scientific advice on new drugs to the TGA. Its review and subsequent recommendation follows the TGA evaluation of clinical pharmacological quality and safety data submitted in January 2005, and later consultation with Pharmaxis.

Pharmaxis shares opened strongly on the news today and reached highs of $2.45. At press time Pharmaxis shares were trading up more than 6 per cent at $2.35.