| Pharmaxis announced that it has filed an application with the European Medicines Agency (EMeA) to market Bronchitol in Europe for the treatment of cystic fibrosis Sydney, Australia | October 29, 2009 | Pharmaceutical company Pharmaxis (ASX:PXS) today announced that it has filed an application with the European Medicines Agency (EMeA) to market Bronchitol in Europe for the treatment of cystic fibrosis.
Dr Alan Robertson, Pharmaxis Chief Executive Officer said; “We are excited to have arrived at this important milestone in bringing Bronchitol to the worldwide cystic fibrosis community. Since reporting positive results from our first Phase 3 trial in May of this year, a dedicated team within Pharmaxis has compiled the comprehensive electronic submission required and I am pleased to say it has been filed overnight with the EMeA.”
“Our marketing authorization application is being reviewed through the European Union’s centralized procedure and will, if successful, give us immediate access to all European Union member countries. There are approximately 40,000 people in Europe who are affected by cystic fibrosis. Pharmaxis expects to know the outcome of the review in the second half of 2010.”
In September Pharmaxis completed recruitment of a second Phase 3 clinical trial required for submission of a new drug application to the US Food and Drug Administration. The study is expected to report during the first half of 2010.
About Bronchitol
Pharmaxis Ltd is developing Bronchitol for the management of chronic obstructive lung diseases including bronchiectasis, cystic fibrosis and chronic bronchitis. Bronchitol is a proprietary formulation of mannitol administered as a dry powder in a convenient hand-held inhaler. It is designed to hydrate the lungs, restore normal lung clearance mechanisms, and help patients clear mucus more effectively. Clinical studies have shown Bronchitol to be well tolerated, to improve lung function and quality of life, and to stimulate mucus hydration and clearance in people with bronchiectasis and cystic fibrosis.
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 and immune disorders. Its development pipeline of products includes Aridol for the management of asthma, Bronchitol for cystic fibrosis, bronchiectasis and chronic obstructive pulmonary disease (COPD), PXS25 for the treatment of lung fibrosis and PXS4159 for asthma.
Founded in 1998, 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.
SOURCE: Pharmaxis Ltd, |
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