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.
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.
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.
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.