Pharmaxis prescribes a shake-up to fix FDA woes
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.
Frequently Asked Questions about this Article…
Pharmaxis replaced CEO Alan Robertson to shift the company’s focus from drug development to the commercialisation of its cystic fibrosis treatment Bronchitol. The board appointed COO Gary Phillips to immediately review the business model and implement changes aimed at speeding up commercial efforts.
Gary Phillips is Pharmaxis’s chief operating officer and a three‑decade veteran of the pharmaceutical sector. He has held executive roles including time at Novartis and was brought in to lead a commercial review and drive Bronchitol sales growth.
Advisers to US regulators gave Bronchitol a negative review two months ago, which the company says makes FDA approval less likely at the expected decision later this month. Pharmaxis’s chairman warned these advisory comments create likely delays to commercialisation in the United States.
Pharmaxis plans to focus on maximising Bronchitol sales in Europe and Australia first, while also working to enter new markets in eastern Europe, the Middle East and South America, according to Gary Phillips.
The market reacted negatively: Pharmaxis shares closed 8.4% lower on the day of the announcement, trading at 55 cents, reflecting investor concern about regulatory delays and the shift in strategy.
Analysts note that while Gary Phillips is a strong commercial candidate, significant risks remain—primarily the expected delays to US approval of Bronchitol. Those regulatory setbacks could weigh on long‑term growth and valuation.
Yes. Gary Phillips said he plans to work with the US Food and Drug Administration to seek approval for Bronchitol, while also engaging with the Australian government to improve patient take‑up in domestic markets.
Investors should track any FDA timelines or announcements (a decision was expected later this month), updates from Gary Phillips’s business model review, reported sales momentum in Europe and Australia, progress entering new markets, and any further analyst commentary on regulatory risk.
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