Pharmaxis prescribes a shake-up to fix FDA woes

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 biotech firm said Dr Robertson would be replaced immediately by chief operating officer Gary Phillips, who would review Pharmaxis' business model.

Two months ago, Pharmaxis was hit by a set-back when advisers to US regulators negatively reviewed Bronchitol. That has made it less likely the Food and Drug Administration would approve the drug for the US market later this month.

"Pharmaxis is facing likely delays in the commercialisation of Bronchitol in the United States," chairman Malcolm McComas said. "Gary Phillips will review the current business model and implement a number of changes."

Pharmaxis shares closed 8.4 per cent lower on Tuesday at 55¢.

Mr Phillips has served as an executive of Swiss pharmaceutical company Novartis and is a three-decade veteran of the sector.

He said the firm had to focus on maximising the growth of Bronchitol's 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.

Mr Phillips said he was planning to work with the FDA to gain approval for Bronchitol, and with the Australian government to help improve the take-up of Bronchitol by patients.