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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 in treating patients with both cystic fibrosis and bronchiectasis.
Bronchitol is an Australian discovered and developed product, which was approved for marketing in Australia in February 2011 and listed for reimbursement on the Australian Pharmaceutical Benefits Scheme in August 2012. In April 2012 Bronchitol was approved for marketing in the European Union by the European Medicines Agency. In October 2012 Bronchitol was approved by NICE in the U.K, opening the door for reimbursement by the National Health Service.
The results from a major Phase 3 trial with Bronchitol in patients with cystic fibrosis demonstrated that Bronchitol is an effective treatment with an acceptable safety profile. There have been limited therapeutic advances in the past decade to help clear congested lungs for patients with cystic fibrosis, a condition which affects 75,000 people worldwide. Bronchitol has been awarded fast-track status in the U.S., and orphan drug designation in both the US and EU.
The product is also being developed for use in bronchiectasis, a disease affecting 600,000 globally. Bronchitol will be the first targeted medication for this condition in over 20 years. A Phase 3 clinical trial of Bronchitol in people with bronchiectasis found that it delivered a highly significant improvement in users' quality of life. A second Phase 3 clinical trial is in progress around the world and is studying the effects of Bronchitol on reducing the infectious episodes, antibiotic use and hospitalization stays for patients with bronchiectasis.
Recent Bronchitol Milestones
- European cystic fibrosis clinical trial in paediatric patients begins
- FDA provides complete response letter recommending an additional clinical trial for Bronchitol
- Pharmaxis signs US$40 million financing agreement with NovaQuest for continued development, manufacturing and commercialisation of Bronchitol for cystic fibrosis
- Bronchitol approved by NICE in U.K
- U.S. FDA accepts Bronchitol New Drug Application for review
- Bronchitol listed on the Australian Pharmaceutical Benefits Scheme (PBS) for the treatment of cystic fibrosis
- Bronchitol receives recommendation for CHMP European Marketing Authorisation for cystic fibrosis
- Bronchitol receives TGA approval for treatment of Australian CF patients
- Major Phase III trial of Bronchitol in Bronchiectasis reaches recruitment
- Extended benefit with Bronchitol in second Phase 3 cystic fibrosis trial
- Presentation of CF302 data at North American Cystic Fibrosis Conference
- Combined positive Phase 3 CF trial results announced
- Agreement for European marketing of Bronchitol
- Completion of second Phase 3 trial for Bronchitol treatment of cystic fibrosis
- Application filed to EMeA to market Bronchitol in Europe for treatment of cystic fibrosis
- Screening commenced for Phase 3 trial for Bronchitol treatment of bronchiectasis
- A second pivotal Phase 3 trial with Bronchitol in patients with cystic fibrosis demonstrated improvement in lung function.
- An oral presentation of the cystic fibrosis phase 3 trial results at the European annual cystic fibrosis scientific meeting
Click HERE for the approved Australian Bronchitol Product Information