Singapore, Aug 31, 2010: Ahead of the anticipated regulatory approval for Bronchitol, Australian pharmaceutical company, Pharmaxis, has signed a six-year agreement with global biopharma services company, Quintiles, to support the launch and commercialization of the product in Western Europe.
Two completed phase III 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.
Pharmaxis' acting CEO Mr Gary Phillips said, “This important development means that Pharmaxis will move into the key European markets with a clear commercialization plan. We will be bringing on board the European expertise and capabilities of a well recognized 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. We have selected Quintiles to help manage market launch and accelerate product uptake because the local experience of the Quintiles organization will allow rapid access to each of the individual country markets.”
Once approved, 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 Quintiles throughout Western Europe while marketing and market support will be managed by the Pharmaxis office in the UK.
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