Investor Centre

Pharmaceutical company Pharmaxis (ASX: PXS) today announced it has signed an Option and Asset Purchase Agreement with Boehringer Ingelheim International GmbH(Boehringer) for the Pharmaxis Semicarbazide-Sensitive Amine Oxidase/Vascular Adhesion Protein-1 (SSAO/VAP-1) Inhibitor PXS4728A.

Pharmaceutical company Pharmaxis (ASX: PXS) today announced that it has commenced a Phase 1 clinical trial of  its Semicarbazide-Sensitive Amine Oxidase/Vascular Adhesion Protein-1 (SSAO/VAP-1) Inhibitor (PXS4728A) investigating its potential to treat inflammatory diseases.

PXS4728 is a highly selective small molecule inhibitor of SSAO that can be administered orally and has already demonstrated acceptable drug like properties during pre-clinical development. 

The initial stage of the trial is a single ascending dose study being conducted in 48 subjects at an Australian Phase 1 clinical trial centre.  If these results are positive, the Company will proceed to a multiple ascending dose study in 24 subjects. The trial is expected to report in the third quarter of 2015 and cost approximately $2 million.

The SSAO enzyme has emerged as a target of interest for various inflammatory diseases during the last 12 months and a recent peer reviewed publication validated its particular importance in liver diseases such as Non-Alcoholic Steatohepatitis (NASH). The NASH market is an area of high unmet clinical need and has been estimated by industry analysts to reach approximately $1.6 billion by 2020 with a number of companies engaged in active research and clinical development. The high prevalence of type 2 diabetes and obesity, which lead to NASH and other non-alcoholic fatty liver diseases, is expected to boost market growth.

Pharmaxis CEO Mr Gary Phillips said, “The Company has been investing carefully in its early stage pipeline over the past two years as part of its plan to refocus the Pharmaxis business. PXS4728A is the first drug candidate from our amine oxidase research platform to have passed all its pre-clinical tests and be cleared to progress to human trials.  Having successfully completed the partnering of Bronchitol for the US late last year, it is now appropriate to make a further investment in the SSAO program, an investment that we believe will enhance the Company’s partnering negotiations which are continuing to progress to plan.”

Pharmaceutical company Pharmaxis (ASX: PXS) today announced it has entered into an exclusive distribution and supply agreement with global pharmaceutical company Chiesi Farmaceutici SpA (Chiesi) for the commercialisation of Bronchitol® (mannitol) in the United States.  As a precursor to this agreement Pharmaxis has settled its dispute with NovaQuest Pharma Opportunities Fund III (NovaQuest) and entered an Amended and Restated Financing Agreement.

Under the terms of the commercialisation agreement Chiesi is responsible for funding up to US$22 million of the cost of the phase 3 clinical trial of Bronchitol which recently enrolled its first patient.  Subject to approval in the United States, Bronchitol will be sold as part of Chiesi’s cystic fibrosis portfolio which includes Bethkis®(tobramycin inhalation solution) and Pertzye® (pancrelipase) delayed-release capsules, both launched in the US earlier this year.  Milestones totaling up to US$25 million are payable tied to the launch of Bronchitol, and on achieving certain annual sales levels.

Pharmaxis will manufacture Bronchitol on commercial terms for Chiesi but should it be independently sourced in the future by Chiesi, the Agreement provides for an ongoing share of sales revenue for Pharmaxis.

Under the terms of the amended Financing Agreement, NovaQuest will receive reduced financial terms on its existing US$20 million investment and no further investment by NovaQuest is required.