Pharmaxis slashes staff after FDA red-flags cystic fibrosis treatment

Australia's struggling Pharmaxis is reaching for the budget ax two months after the FDA red-flagged its application to market Bronchitol to cystic fibrosis patients. The biotech says it will cut 48 jobs, or about a third of its workforce, as it gets ready to try to satisfy regulators with another study of the therapy, which is marketed in Europe.

Hunkering down while it prepares to take another crack at a pivotal study, the biotech's execs say that they're also scouting for a U.S. partner on Bronchitol while pursuing ongoing discussions to raise fresh funds to advance its pipeline.

"We have some valuable product opportunities at all stages of development and are restructuring the company to take full advantage of that potential in a manner that conserves cash and puts us in a stronger position to navigate the road ahead," said CEO Gary Phillips in a statement.

Shares of Pharmaxis--which has reached an agreement with the FDA on the design of the next trial--slid 13% on the news, falling to A$0.20, according to a Reuters report.

FDA officials agreed with a panel of outside experts who concluded back in January that Pharmaxis had not provided the data needed to demonstrate that Bronchitol is safe and effective.

"The submitted data do not provide a favorable benefit‐risk balance to support the use of inhaled mannitol in patients with cystic fibrosis 6 years of age and older," stated the FDA's rejection letter. "The determination of efficacy based on the two clinical trials are not adequate because of the treatment‐related frequent early dropouts in trial 301 for which the primary statistical analyses did not account and the lack of statistical significance in trial 302 for the primary endpoint."

- here's the press release (PDF)
- read the Reuters story

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