|Media Release||25 June 2012|
Pharmaceutical company Pharmaxis (ASX: PXS) today welcomed an announcement by the Federal government that Bronchitol will be listed on the Australian Pharmaceutical Benefits Scheme (PBS) for the treatment of cystic fibrosis.
The Minister for Health Tanya Plibersek has announced Bronchitol will be reimbursed for the treatment of cystic fibrosis (CF) patients, including children older than six years, who cannot use or are nonresponsive to medicines already listed on the PBS.
Dr Alan Robertson, the CEO of Pharmaxis said: "Cystic fibrosis is a challenging disease to treat and Bronchitol represents the first new drug ever listed on the PBS to tackle the fundamental problem responsible for loss of lung function. We are pleased that this innovation will shortly be available to patients through the Pharmaceutical Benefits Scheme and look forward to monitoring the impact of Bronchitol on people's lives over the coming years. This reimbursement decision is a testament to the dedication of the many people involved in developing Bronchitol for cystic fibrosis and we welcome the news."
Mr David Jack, CEO of Cystic Fibrosis Australia said: "New therapeutic advances are desperately needed and the PBS listing is excellent news. I am pleased for the CF Community that a product of Australian research and innovation has brought a significant advance in patient care. Improving lung function and preventing lung infections are key to maintaining good health, so new treatment options have the potential to make a real difference in the lives of CF patients."
When listed, the approved price of Bronchitol will be $31.00 per day.
More than 600 cystic fibrosis patients were part of two large scale clinical trials of Bronchitol. The clinical trials were managed by Pharmaxis which coordinated studies in 95 hospitals and CF centres throughout the world.
Bronchitol is approved for marketing in Australia and Europe and a New Drug Application has been lodged with the FDA seeking marketing approval in the USA.
SOURCE: Pharmaxis Ltd, Sydney, Australia
CONTACT: Alan Robertson íV Chief Executive Officer
Ph: +61 2 9454 7200 or email firstname.lastname@example.org
Felicity Moffatt, phone +61 418 677 701 or email email@example.com
Pharmaxis (ACN 082 811 630) is a specialist pharmaceutical company involved in the research, development and commercialization of therapeutic products for chronic respiratory disorders. Its product AridolR for the assessment of asthma is launched in a number of key markets. Its development pipeline of products includes, Bronchitol for cystic fibrosis, bronchiectasis and chronic obstructive pulmonary disease (COPD), PXS25 for the treatment of lung fibrosis and ASM8 and PXS4159 for asthma. Pharmaxis is listed on the Australian Securities Exchange (symbol PXS). The company is headquartered in Sydney at its TGA-approved manufacturing facilities. For more information about Pharmaxis, go to www.pharmaxis.com.au or contact Investor Relations on phone +61 2 9454 7200.
Bronchitol has been developed to help clear mucus (a major source of lung infections), improve lung function and reduce exacerbations in patients with cystic fibrosis.
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 safe, effective, and well tolerated in treating patients cystic fibrosis.
About Cystic Fibrosis
In a healthy person, there is a constant flow of mucus over the surfaces of the air passages in the lungs, removing debris and bacteria. In CF, an inherited disease, a defective gene disrupts ion transport across the epithelial membrane within cells. In the lungs, this leads to a depletion of the airway surface liquid that normally bathes the cilia, and a resultant reduction in mucociliary clearance. The result is thick, sticky mucus that clogs the lungs, severely restricting the natural airway-clearing process. It also increases the potential for bacteria to become trapped and for inflammation, thus creating an unhealthy lung environment that leads to life-threatening lung infections.
Forward-looking statements in this media 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 media 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 cannot guarantee that any product candidate will receive regulatory approval or that we will seek any such approval.
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