Updated on 14 March 2013
Growth of Bronchitol
Pharmaxis is approaching a 10 percent market share of adult patients in Germany and continues to make steady progress month by month. The company is learning more about how the product is being used and has a number of initiatives planned for the months ahead to improve growth rate and patient adherence. Clearing reimbursement hurdles in the remaining EU countries is a challenge given the current economic climate and fast changing regulations. Pharmaxis has, however, succeeded in England which perhaps has the most rigorous process and is pushing as fast as possible into other EU markets.
Restrictive entry criteria for reimbursement has led to a slower than expected uptake of new patients. The company is continuing to work with the Australian government to refine the wording of these restrictions.
The company aims to leverage the approvals it has in Europe and Australia to enter new markets in Eastern Europe, the Middle East and South America. Progress in this regard will be reported in the second quarter of calendar 2013.
The outcome of the likely meeting with the FDA regarding Bronchitol and the outcome of the B305 trial are key to determining any necessary changes to the company's business model. There will be clarity around both issues in the second quarter of calendar 2013 and more specific guidance on the changes will be provided at that point.