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

SYDNEY, Oct. 24, 2011 /PRNewswire/ -- Pharmaceutical company Pharmaxis (ASX: PXS) today announced the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a Marketing Authorisation for Bronchitol, clearing the way for the product to be used in Europe "for the treatment of cystic fibrosis in adults as an add-on therapy to best standard of care."

Pharmaxis expects the European Commission to confirm this opinion and grant the Marketing Authorisation for Bronchitol in January 2012.

Pharmaxis CEO Dr Alan Robertson welcomed the decision saying, "This outcome from the CHMP meeting is an important milestone for the company.  It is good news for the cystic fibrosis (CF) community which has supported us throughout the development of Bronchitol.  As the life expectancy of CF patients has lengthened, the size of the adult population in Europe has increased.  Bronchitol will be used for CF patients aged 18 and above, which represents about two thirds of all patients who could potentially benefit from the drug. Pharmaxis will undertake a short term clinical trial in children (age 6-17) with a view to extending the license to this age group.

"Bronchitol is a drug which was discovered and developed in Australia.  It is approved for marketing in Australia and is now set to become available throughout the 27 countries of the European Union.  This outcome represents the culmination of a great deal of work by many people.

"Pharmaxis will move quickly to commercialise Bronchitol in Europe.  We have established our supply and logistics arrangements and advanced launch preparations and pricing applications with our marketing partner, Quintiles.  The awareness of Bronchitol's clinical data amongst CF clinicians has increased through publications and presentations at scientific conferences.  European clinicians provided valuable support to the CHMP decision and
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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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