- Pharmaceutical research company Pharmaxis (PXS) has been granted U.S. FDA approval for Bronchitol as an add‐on maintenance therapy to improve pulmonary function in adult cystic fibrosis patients
- Bronchitol is already sold in several markets including Australia, Europe and Russia and will now be sold in the world’s largest market
- The approval triggers a US$7 million (around A$10 million) payment from U.S. licensee Chiesi Farmaceutici SpA
- It will be followed by another US$3 million (roughly A$4.28 million) upon shipment of stock from Pharmaxis’ facility in Sydney in the first quarter of 2021
- Pharmaxis said the milestone payments will provide a funding runway for the development of its PXS‐5505 drug
- The company released details today of a clinical trial of the drug in 42 myelofibrosis patients in Australia and at international sites
- Shares have opened 61.9 per cent higher at 14.3 cents
Pharmaxis (PXS) has been granted US Food and Drug Administration (FDA) approval for one product and has released details of an upcoming study for another.
Bronchitol
The company has received FDA approval for the sale of Bronchitol in the U.S. as an add‐on maintenance therapy to improve pulmonary function in adult cystic fibrosis patients.
Pharmaxis Chairman Malcolm McComas said the company is very pleased that the drug, discovered in Australia, will now be available in the United States.
“Approval in the world’s largest market is a testament to the capability of the Pharmaxis clinical team who designed and conducted the three large scale phase three clinical trials establishing Bronchitol’s safety and efficacy and our particular thanks goes to all the patients and healthcare professionals who made those trials possible,” the Chairman said.
Bronchitol is already sold in several markets including Australia, Europe and Russia and Pharmaxis CEO Gary Phillips said the production of the product for the U.S. will have broader benefits.
“The additional volume of Bronchitol that Pharmaxis will produce at our Sydney production facility to supply the US, on top of Australia and 17 other international markets, greatly increases capacity utilisation and consequently radically improves the cost of goods,” Gary stated.
The approval also triggers a US$7 million (around A$10 million) payment from US licensee Chiesi Farmaceutici SpA and will be followed by another US$3 million (roughly A$4.28 million) upon the first commercial shipment of stock in the first quarter of 2021.
Pharmaxis will launch the product in the second quarter of 2021 and expects its mannitol business, comprising Bronchitol and Aridol, to be cash flow positive from the 2021 financial year.
“The FDA approval of Bronchitol is transformational for Pharmaxis because the milestone payments from Chiesi together with positive cash flows from the mannitol business segment allow us to move confidently ahead with the development of our lead clinical development asset PXS‐5505 for the treatment of myelofibrosis,” the CEO continued.
PXS‐5505 study
The company also released details today of a clinical trial of PXS‐5505 in 42 myelofibrosis patients at sites in Australia and in South Korea.
PXS-5505 is a pan‐LOX inhibitor and will be trialled in patients who are intolerant, unresponsive or ineligible for treatment with approved JAK inhibitor drugs.
The company expects the first patient to be recruited in the next quarter.
Shares have been trading 61.9 per cent higher at 14.3 cents at 10:25am AEDT.