Pharmaxis has a strong suite of products in development, focused on treating respiratory diseases. The target disease states are under-treated and many have broad patient bases.
Pharmaxis’ first commercial product, the innovative Aridol lung function test, is designed to help doctors diagnose and manage asthma by detecting active airway inflammation through measuring airway hyper-responsiveness. By having patients inhale Aridol via a simple hand-held device, doctors may determine the severity of a patient’s inflammation and prescribe the right amount of medication to bring it under control. The Aridol challenge test potentially prevents inappropriate treatment and may help patients better comply with their therapies. Asthma affects over 52 million people worldwide.
The company’s first product, Aridol, is approved for sale in Australia, major European countries and Korea. It is the first and only approved Europe-wide lung function test and the world’s first approved indirect challenge test for asthma.
Aridol is involved in investigator-sponsored clinical trials worldwide, treating thousand of patients. It has also been included in both international and Australian official guidelines for managing asthma — recognition and endorsement by both global and Australian experts that Aridol is a significant addition to the tools available to help asthma patients. Bodies and guidelines endorsing Aridol include:
Pharmaxis’ key product in development, Bronchitol, is a drug designed to reduce the amount of mucus build-up in the lungs of patients suffering from chronic respiratory conditions.
Pharmaxis is developing Bronchitol for diseases including cystic fibrosis, bronchiectasis and chronic bronchitis. Bronchitol is a proprietary formulation of mannitol administered as a dry powder in a convenient hand-held inhaler. Bronchitol hydrates the lungs, helps restore normal lung clearance, and allows patients to clear mucus more effectively. Clinical studies have shown Bronchitol to be effective and well tolerated, to improve quality of life and mucus flow in people with cystic fibrosis and bronchiectasis.
Phase III clinical trials are underway for the use of Bronchitol in cystic fibrosis. Bronchitol improves the lung function of people with cystic fibrosis, and the clinical trials are designed to show that Bronchitol helps with lung hygiene and improves quality of life for sufferers, who number 75,000 worldwide.
There have been no therapeutic advances to help clear congested lungs for patients with cystic fibrosis for over a decade, and based on positive Phase II trial results, the product has been awarded fast-track status in the US, and orphan drug designation in both the US and EU.
The product is also being developed for use in bronchiectasis, with a pivotal Phase III clinical trial finding that it delivered a highly significant improvement in users’ quality of life.
Bronchiectasis is a progressive lung disease affecting 580,000 people worldwide, and Bronchitol is the first targeted medication for sufferers in over 20 years. The drug is supplied on a compassionate use basis to patients worldwide. Bronchitol has orphan drug status in the U.S.. The medicine is expected to be approved for bronchiectasis first in Australia, and later in the U.S. and Europe following the completion of a further Phase III trial.
Cystic fibrosis
Bronchiectasis
