Australian drug maker Pharmaxis has replaced its long-serving chief executive Alan Robertson as it looks to shift focus away from development towards the commercialisation of its cystic fibrosis treatment Bronchitol.
The biotechnology company said that Dr Robertson would be replaced by chief operating officer Gary Phillips immediately, and that he would lead a review into Pharmaxis' business model.
The shake-up comes two months after Pharmaxis was hit by a setback when advisers to US regulators negatively reviewed Bronchitol. That decision has made it less likely that the Food and Drug Administration would approve the drug for the key US market when it meets this month.
"Pharmaxis is facing likely delays in the commercialisation of Bronchitol in the United States," the company's chairman, Malcolm McComas, said.
"Gary Phillips will review the current business model and implement a number of changes aimed at securing Pharmaxis' position as a commercially successful pharmaceutical company and maximising shareholder value."
Shares in Pharmaxis closed 8.4 per cent lower on Tuesday at 55¢.
Mr Phillips, who was also appointed to Pharmaxis' board of directors, had served as a chief executive of Swiss pharmaceutical company Novartis and is a three-decade veteran of the pharmaceutical sector.
He said the company had to focus on maximising the growth of Bronchitol's current sales in Europe and Australia, while working to enter new markets in eastern Europe, the Middle East and South America.
Deutsche Bank healthcare analyst Nicholas Cameron said Mr Phillips was a "very good candidate" with a wealth of experience in commercially oriented roles.
However, Mr Cameron said he expected significant risks to remain with the company in the longer term, given the expected delays in the US approval of Bronchitol.
Even if the Phase III trial of bronchiectasis was found to be successful, it would be entering a market that was more fragmented, Mr Cameron said.
Mr Phillips said he was planning to work with the Food and Drug Administration to gain approval for Bronchitol, and with the Australian government help improve the take-up of Bronchitol by patients here.