News

For the latest media releases and news about Pharmaxis Ltd, please select from the following articles. Material news announcements made by Pharmaxis are first filed with the Australian Securities Exchange (ASX) and are also available on the ASX website.

19th Mar 21

Chiesi USA Announces Commercial Launch of Pharmaxis’ Cystic Fibrosis Drug Bronchitol

Pharmaxis Ltd (ASX: PXS) today announced that Chiesi USA, Inc. (Chiesi), has launched Bronchitol® (mannitol), an add-on maintenance therapy to improve pulmonary function in cystic fibrosis (CF) patients aged 18 years and older in the United States. Bronchitol, developed by Pharmaxis, is the first dry powder inhaled mucoactive agent providing a compact, portable treatment option for CF patients.

Additionally, Chiesi has announced data from the Pharmaxis Phase 3 global clinical trial (CF303) evaluating the efficacy and safety of Bronchitol in adults with CF has been published online in the Journal of Cystic Fibrosis.

Pharmaxis has so far received a total of US$10 million in Bronchitol milestone payments from Chiesi triggered by FDA approval in October 2020 and the recent first shipment of stock to the USA.

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22nd Feb 21

Pharmaxis Announces First Patient Enrolled in Clinical Trial for New Cancer Treatment

Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) today announced it has enrolled the first patient in a clinical trial studying a potential new treatment for the bone marrow cancer myelofibrosis.

The phase 1c/2a trial cleared by the FDA under the Investigational New Drug (IND) scheme aims to demonstrate that PXS-5505, the lead asset in Pharmaxis’ drug discovery pipeline, is safe and effective as a monotherapy in myelofibrosis patients who are intolerant, unresponsive or ineligible for treatment with approved JAK inhibitor drugs.

Pharmaxis has completed site initiation at several Australian and South Korean hospitals and the first patient has been enrolled. The dose escalation phase of the study that aims to select the optimum dose of PXS-5505.  This first phase, that will recruit up to 18 patients, is expected to conclude and report in 2H 2021 and will be followed by a six-month dose expansion phase (24 patients) to evaluate safety and efficacy. Sites in other countries including the USA will be added for the dose expansion phase.

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9th Feb 21

Pharmaxis Starts Exporting Its Cystic Fibrosis Drug to The USA Following FDA Approval

Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) has announced it has exported the first shipment of its locally developed and manufactured drug Bronchitol®(mannitol) to the USA. The cystic fibrosis (CF) treatment was approved by the US Food and Drug Administration (FDA) on 30 October 2020. Following receipt of an initial payment of US$7 million (~A$10 million) from its exclusive US distributor Chiesi, Pharmaxis will now receive a further US$3 million (~A$4 million) milestone payment.

Read full media release - pdf