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Pharmaxis Announces Major Milestone: Positive Bronchitol Opinion for Europe
Date:10/24/2011

are looking forward to Pharmaxis bringing this new therapeutic treatment option to their patients in the near future," Dr Robertson said.

Professor Stuart Elborn, President of the European Cystic Fibrosis Society, stated; "Life expectancy in cystic fibrosis is improving but there remains an urgent need for new therapies which can improve lung function and reduce exacerbations.  Bronchitol increases mucociliary clearance and will be the first approved therapy in Europe with this mechanism of action and has been shown to improve both lung function and reduce exacerbations when added to standard medications in use today.  I welcome this decision by the CHMP."

Robert J. Beall, Ph.D, President and CEO of the American Cystic Fibrosis Foundation said; "The Cystic Fibrosis Foundation is delighted to see an important new CF medicine being made available to patients in Europe.  It takes a lot of dedication from industry and the CF community to develop a drug to this point.  We are proud to have played a part in this process through our clinical trial group and look forward to Bronchitol being submitted to the FDA early next year."

Bronchitol's approval for the treatment of cystic fibrosis patients in Australia and the European Marketing Application are based on the results of two Phase 3 clinical trials involving more than 600 people and conducted in 95 centres throughout the world.  

CONTACT: Alan Robertson – Chief Executive Officer
Ph: +61 2 9454 7200 or email alan.robertson@pharmaxis.com.au

RELEASED THROUGH:
Australia:
Felicity Moffatt, phone +61 418 677 701 or email felicity.moffatt@pharmaxis.com.au

About Pharmaxis

Pharmaxis (ACN 082 811 630) is a specialist pharmaceutical company involved in the research, devel
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SOURCE Pharmaxis
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Related medicine technology :

1. Pharmaxis Launches ARIDOL® (Mannitol Inhalation Powder) Bronchial Challenge Test Kit for the Assessment of Bronchial Hyperresponsiveness
2. Pharmaxis Previews New Bronchial Challenge Test at the Annual Meeting of the American College of Allergy, Asthma and Immunology
3. Pharmaxis Announces Positive Combined Phase 3 Cystic Fibrosis Trial Results
4. FDA Approves Pharmaxis ARIDOL™ (Mannitol Inhalation Powder) Bronchial Challenge Test Kit for the Assessment of Bronchial Hyperresponsiveness
5. Pharmaxis Announces Positive Results of Phase 3 Cystic Fibrosis Trial
6. Pharmaxis Announces Milestone in Phase III Trial for Cystic Fibrosis
7. Pharmaxis Announces New Drug Application Submission for Aridol(TM)
8. ASX/NASDAQ Media Release: Pharmaxis Files First Marketing Application for Bronchitol in Australia
9. Pharmaxis Concludes Special Protocol Assessment with FDA for Bronchitol Phase 3 Trial
10. Pharmaxis Establishes Named Patient Program for Bronchitol
11. Pharmaxis Long-Term Safety Study of Bronchitol Completes
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