Pharmaxis Ltd Receives Approval to Market Bronchitol in the EU

Published: Apr 27, 2012

ELTVILLE, Germany, April 27, 2012 /PRNewswire/ -- Pharmaceutical company Pharmaxis (PXS.AX) is pleased to announce it has received Marketing Authorisation for Bronchitol from the European Commission. The licence allows the new cystic fibrosis treatment to be made available for patients aged 18 and above as an add-on therapy to the best standard of care in 29 European countries.

Pharmaxis CEO Dr Alan Robertson said, "This is a very significant event, which means that patients living with cystic fibrosis in Europe will now be able to receive the proven clinical benefits of Bronchitol."

CF patients in Germany and the UK, where there is less requirement for pricing and reimbursement approval before launch, will be first to benefit from Bronchitol. These two countries make up 40% of the European market by value. Pharmaxis expects stock to be available for sale in Europe by June 1st ahead of the official launch of the product, which will take place at the European Cystic Fibrosis Conference in Dublin from 6th - 9th June 2012.

Bronchitol has been developed to help clear the airways of people with the world's most common, life limiting genetic disease, cystic fibrosis. In two large Phase 3 clinical trials, Bronchitol improved mucus clearance, improved lung function and reduced infectious episodes compared to control when patients were treated for 6 months.

Dr Robertson said, "We have built considerable momentum around Bronchitol in recent months with the German and UK sales teams fully recruited and trained."

"Pharmaxis has now secured three drug approvals in the world's largest pharmaceutical markets: the lung function test Aridol in Europe and the US and now approval for Bronchitol in Europe and Australia. This is a credit not only to the company but also the investigators and patients throughout the world who have taken part in our clinical programs," Dr Robertson said.

About Pharmaxis

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 AridolĀ® 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 or contact Investor Relations on phone +61-2-9454-7200.

About Bronchitol

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 effective in treating patients with 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

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.



Chandler Chicco Agency

Samina Qutub

phone: +44(0)20-7632-1816


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