Oct 24 2011
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 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.