Pharmaxis updates on US Bronchitol progress

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Sydney-based Pharmaxis (ASX:PXS) has provided an update on the FDA's consideration of its cystic fibrosis therapy BRONCHITOL (mannitol).

Italian company Chiesi is commercialising BRONCHITOL in the US and is also managing it through the country's regulatory process.

In a statement, Pharmaxis said Chiesi has received detailed advice from the FDA following the Complete Response Letter it received in June.

Based on the detailed advice, Chiesi has added an additional month to its approval timetable with FDA review of BRONCHITOL now expected to be completed in the second quarter of 2020.

In its Complete Response Letter, the FDA required Chiesi to revise BRONCHITOL's packaging and user instructions, and then conduct a human factor study (HFS) demonstrating the revisions would enable healthcare professionals to properly administer the mannitol tolerance test.  

Pharmaxis said Chiesi submitted a protocol for the HFS last quarter to ensure the FDA’s requirements were fully incorporated in the study. The FDA has advised Chiesi to increase the size of the HFS. The company said it has also incorporated other FDA recommendations into the final study design.

Pharmaxis CEO Gary Phillips said, “This important regulatory step has now been completed and the study can commence.  While the timetable has extended by a month, importantly the FDA advice sought and received by Chiesi ensures the HFS is conducted in accordance with the FDA’s expectations.”  

US regulatory approval and the supply of BRONCHITOL for the US commercial launch will trigger a US$10 million milestone payment to Pharmaxis. The company will also receive mid to high teen percentage royalties on in‐market net sales.