Updated on 14 March 2013
Mr Phillips said: "We have overcome a number of hurdles to bring Bronchitol to cystic fibrosis patients in Europe and Australia and recently secured additional funding through a financing agreement with NovaQuest. It is vital that we now focus our resources on maximising the growth of Bronchitol's sales while at the same time accelerating the addition of new territories." Mr Phillips also outlined some of the key initiatives to be undertaken in the near future:
US Food and Drug Administration (FDA) response
The company is expecting to receive a response from the FDA next week concerning its application for marketing approval for Bronchitol in cystic fibrosis patients aged 6 and above. Pharmaxis anticipates it will need to request a meeting with the FDA in the second quarter of calendar 2013 to clarify any additional requirements the FDA may have. The company remains committed to making Bronchitol available to the world's largest cystic fibrosis market.
Bronchitol remains the only airway clearance product worldwide in phase 3 clinical trials for bronchiectasis. There are no products currently approved for this serious respiratory disease affecting many hundreds of thousands of people. The company's current trial (B305) is the largest and longest study ever conducted in bronchiectasis, and reached a major milestone last week when the last patient in the study had their last clinic visit. The primary endpoint of the study is a reduction in exacerbations. The data from the study will soon be collated and analysed. Pharmaxis expects to report the top line results in the second quarter of calendar 2013. The result from B305 will have significant implications for Bronchitol - potentially providing access to significant markets. The outcome is, therefore, central to the company's review of its business model.