logo-loader
Pharmaxis Ltd

Pharmaxis continues to add value to portfolio assets; Bronchitol reaches pivotal stage

The company is confident that the FDA will have the information it requires to be able to approve Bronchitol by Q1 2020.

Bronchitol
Pharmaxis is expected to receive $6 million in tax credits for FY2019

Pharmaxis Ltd (ASX:PXS) is different from other pharmaceutical research companies in that it has a portfolio approach to build value and mitigate risk. 

Most companies have one asset under development that will lead inevitably to either a profitable exit or a complete loss.

The June quarter saw many of Pharmaxis’ portfolio assets move forward, adding value that can be realised down the track at multiple time points, rather than one ‘Russian roulette’ moment.

Bronchitol

The June quarter saw one of the company’s long‐term pipeline assets reach a pivotal moment when the FDA Pulmonary and Allergy Drug Advisory Committee (PADAC) met to consider questions put to them by the FDA on the efficacy and safety of Bronchitol for the treatment of cystic fibrosis in adult patients. 

The positive vote led to a complete response letter from the FDA that provides a clear path to approval subject to the completion of a human factor study by Chiesi.

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

Pharmaxis is confident that the FDA will have the information it requires to be able to approve Bronchitol by Q1 2020.  

The opening of the US market for Bronchitol builds on the successful relaunch of Aridol earlier this year.

A US$10 million Bronchitol milestone payment is anticipated in Q2 2020 and the Bronchitol and Aridol franchise is expected to turn into a cash flow positive and sustainable business next year.

READ: Pharmaxis sees progress in Boehringer Ingelheim’s clinical trial in patients with NASH

Another plank of sustainability for Pharmaxis is the potential cash flow from the deal struck with Boehringer for Pharmaxis’ first in class AOC3 inhibitor for the liver disease NASH. 

NASH is a major cause of liver fibrosis and cirrhosis and is an area of high unmet medical need with no treatments currently available.

Boehringer expects to report the results from the NASH phase 2a study in Q4 this year after completing both the study and internal post-study analysis.

$6 million tax credit

Interestingly, Pharmaxis’ early-stage research programs don’t carry the heavy investments associated with later-stage clinical studies and the support from the Australian Government in the form of an R&D tax incentive further improves its cost-effectiveness. 

The $6 million tax credit Pharmaxis is expected to receive for FY2019 is allied to the unprecedented productivity of its drug discovery team who have managed to get four drugs of their own invention into the clinic in the last five years with one more on the way in 2020, representing a great return on investment.  

The company’s systemic pan LOX inhibitor for myelofibrosis and pancreatic cancer completed the first part of its phase 1 study in healthy volunteers and will continue with the second phase later this year with a view to commencement of the first study in patients first half next year.

Quick facts: Pharmaxis Ltd

Price: 0.21 AUD

Market: ASX
Market Cap: $82.88 m
Follow

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

3 min read