Pharmaxis is an Australian pharmaceutical research company focussed on inflammation and fibrosis with a portfolio of products at various stages of development and approval.
Established in 1998 and listed on the Australian Securities Exchange in 2003 (symbol PXS) the Company’s head office, manufacturing and research laboratories are located in Sydney, Australia.
The Company has a signature partnership with Boehringer Ingelheim on a drug discovered by Pharmaxis which is being trialled to treat the common liver disease NASH and diabetic retinopathy - a leading cause of blindness. These two trials are due to report in the first half of 2019.
The Company’s product pipeline is founded on its expertise in the chemistry of amine oxidase inhibitors and includes Semicarbazide-Sensitive Amine Oxidase (SSAO) for Non- Alcoholic Steatohepatitis (NASH) and diabetic retinopathy; Lysyl Oxidase Like Inhibitors (LOXL2) targeting fibrotic diseases including NASH, pulmonary fibrosis, kidney fibrosis and cardiac fibrosis; Lysyl Oxidase Inhibitors (LOX) targeting severe fibrotic indications including scarring and some cancers; and a dual SSAO/MPO inhibitor for respiratory inflammation, cardiovascular inflammation and inflammatory bowel diseases.
Pharmaxis’ acknowledged expertise in amine oxide inhibitors has attracted interest from leading pharmaceutical companies looking to partner in this rapidly expanding area of medical need. In May 2015, Boehringer Ingelheim acquired the Pharmaxis phase 1 investigational drug BI 1467335 (formerly known as PXS4728A), to develop it for the treatment of the cardiometabolic liver-related condition NASH. A phase 2 clinical trial in NASH commenced in August 2017 triggering payment of a development milestone to Pharmaxis of approximately A$27 million. In January 2018, Boehringer commenced a second indication with BI 1467335, this time in Diabetic Retinopathy (DR). A phase 2a clinical trial is testing the drug in in 100 patients with moderately severe to severe non-proliferative diabetic retinopathy.
Pharmaxis manufacturers and exports its approved products from a purpose built manufacturing facility in Sydney.
- Bronchitol®, an inhaled dry powder for the treatment of cystic fibrosis, has been the subject of three large scale global clinical trials conducted by Pharmaxis. The product is approved and marketed in Europe, Russia and Australia and the third large multicentre clinical trial aiming to secure approval in the United States reported in June 2017. In June 2019 the US FDA issued a complete response letter detailing the remaining matters to be addressed before Bronchitol can be approved for adult CF patients in the US. Pharmaxis believes that the FDA review of the Bronchitol NDA will be completed in Q1 2020. Outside Australia, Pharmaxis partners with a number of specialist companies who have responsibility for their local approvals and ongoing commercialisation of Bronchitol. For more information visit the Bronchitol website.
- Aridol® a lung function test to help diagnose asthma was also the subject of a clinical trial program run by Pharmaxis and is approved and sold in the United States, Europe, Australia and Asia. For more information visit the Aridol website.