logo-loader
Pharmaxis Ltd

Pharmaxis on track to complete FDA approval process for Bronchitol in Q1 2020

If Bronchitol is approved by the US FDA, Pharmaxis will receive US$10 million.

cystic fibrosis
Bronchitol is an inhaled dry powder for the treatment of cystic fibrosis

Pharmaxis Ltd’s (ASX:PXS) US licensee Chiesi Group has received a complete response letter from the US Food and Drug Administration (FDA) detailing the remaining matters to be addressed before Bronchitol® can be approved for adult cystic fibrosis (CF) patients in the US.

Based upon the clear and achievable path to approval communicated in the FDA complete response letter, Pharmaxis believes that the FDA review of the Bronchitol NDA (New Drug Application) will be completed in Q1 2020.

The main requirement included in the FDA complete response letter is that Chiesi revise the product packaging and user instructions; and then conduct a human factor study (HFS) demonstrating that the revised user components enable healthcare professionals to properly administer the mannitol tolerance test.

READ: Pharmaxis welcomes US FDA committee’s recommendation on use of Bronchitol in CF

Pharmaxis CEO Gary Phillips said: “We are confident that the FDA complete response letter provides a clear and achievable path to approval. 

“FDA requested changes to the product packaging and user instructions require that an HFS be conducted. This is targeted for completion by the end of 2019.

“Based on our experience with healthcare professionals in other markets where our training and packaging has supported thousands of mannitol tolerance tests that have been conducted to ensure patients hypersensitive to mannitol are not prescribed Bronchitol, we are very confident the requested FDA changes can be efficiently implemented and will be effective in achieving the desired goal.

“We have been sharing our experiences in other markets with Chiesi and continue to work collaboratively to prepare for a successful introduction to patients in US cystic fibrosis clinics.”   

Background

Bronchitol is an inhaled dry powder for the treatment of cystic fibrosis and has been the subject of three large scale global clinical trials conducted by Pharmaxis.

It is approved and marketed in Europe, Russia, Australia and several other countries.

Chiesi is responsible for the regulatory approval and commercialisation of Bronchitol in the US.

If Bronchitol is approved by the FDA, Pharmaxis will receive a US$10 million milestone payment on the commercial launch of Bronchitol in the US and mid to high teen percentage royalties on in‐market net sales.

Pharmaxis will manufacture and be the exclusive supplier of Bronchitol for the US market.

Quick facts: Pharmaxis Ltd

Price: $0.19

Market: ASX
Market Cap: $73.01 m
Follow

Add related topics to MyProactive

Create your account: sign up and get ahead on news and events

NO INVESTMENT ADVICE

The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is...

In exchange for publishing services rendered by the Company on behalf of Pharmaxis Ltd named herein, including the promotion by the Company of Pharmaxis Ltd in any Content on the Site, the Company receives from said...

FOR OUR FULL DISCLAIMER CLICK HERE

Watch

Pharmaxis hopeful of FDA approval for cystic fibrosis inhalation medicine...

Pharmaxis Ltd (ASX:PXS) chief executive officer Gary Phillips updates Proactive Investors on the FDA approval timeframe for the company’s Bronchitol inhalation medicine used to treat adult cystic fibrosis patients. The healthcare-focused company is confident it will meet information...

on 13/8/19

RNS

Director/PDMR Shareholding

4 days, 6 hours ago

Grant of Share Options

5 days, 5 hours ago

Final Results

6 days, 14 hours ago

Trading Update

on 31/7/19

Board changes

on 12/4/19

2 min read