Pharmaxis in deal to support launch of cystic fibrosis drug

Pharmaxis in deal to support launch of cystic fibrosis drug

Eli Greenblat


August 31, 2010 - 4:07PM

Biotech company Pharmaxis says it has finalised a strategic marketing and sales service agreement for the commercialisation of its cystic fibrosis drug, Bronchitol, for use in Europe.

The company said this morning that ahead of anticipated regulatory approval for Bronchitol, it had signed a six-year agreement with the highly respected Quintiles organisation to support the launch and commercialisation of the product in Western Europe.

Pharmaxis acting chief executive Gary Phillips said: “This important development means that Pharmaxis will move into the key European markets with a clear commercialisation plan. We will be bringing on board the European expertise and capabilities of a well recognised team of leaders in the field.


“Bronchitol is a new advance in the treatment of cystic fibrosis and it’s vital that we engage fully with the CF communities, healthcare professionals, funding bodies and governments across Europe as efficiently as possible.’’




Quintiles is a global biopharmaceutical services company offering clinical, commercial, consulting and capital solutions. The Quintiles network employs 20,000 people across 60 countries.



Two completed Phase 3 clinical trials of Bronchitol have demonstrated early and sustained improvement in lung function in people with cystic fibrosis. The product has been granted orphan drug designation by the European Medicines Agency, which helps accelerates its development and path to commercialisation.



Pharmaxis plans to launch Bronchitol across Western Europe, initially in Germany and the UK in the first quarter of 2011.



The Pharmaxis contract sales representatives will be supported and managed by the Quintiles organisation throughout Western Europe while marketing and market support will be managed by the Pharmaxis office in the UK.



egreenblat@theage.com.au

http://www.theage.com.au/business/pharmaxis-in-deal-to-support-launch-of-cystic-fibrosis-drug-20100831-14f6j.html

Pharmaxis applies to market Bronchitol™ for cystic fibrosis in Europe

Pharmaxis applies to market Bronchitol™ for cystic fibrosis in Europe

29 Oct 2009

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,