Investor Centre

FRENCHS FOREST, Australia and INGELHEIM, Germany – May 18, 2015 – Boehringer Ingelheim and pharmaceutical company Pharmaxis (ASX: PXS) announce that Boehringer Ingelheim has exercised its option and acquired  the investigational drug PXS4728A, to develop it for the treatment of the liver-related condition NASH and to prevent its consequences. PXS4728A is a Semicarbazide-Sensitive Amine Oxidase/Vascular Adhesion Protein-1 (SSAO/VAP-1) Inhibitor discovered by Pharmaxis that works by blocking leucocyte adhesion and tissue infiltration in inflammatory processes. Pharmaxis has developed it through to phase 1 clinical studies, demonstrating oral bioavailability, long-lasting target inhibition and good tolerability and safety. 

NASH is the progressive form of non-alcoholic fatty liver disease (NAFLD), the most common liver disorder in Western industrialized nations.  It is regarded as a major cause of fibrosis and cirrhosis of the liver and is an area of high unmet clinical need. The high prevalence of type 2 diabetes and obesity, which can lead to NASH and its long term consequences, is considered to make NASH one of the most common causes of advanced liver disorders in coming decades.

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) for cystic fibrosis in adults aged 18 years and above in Germany, the United Kingdom and Ireland.

Under the terms of the agreement Chiesi will take over responsibility for the marketing, sales and distribution of Bronchitol from June 2015.  The product was launched in Germany in 2012, in the United Kingdom in 2013 and is planned to be launched in Ireland after the current assessment for reimbursement is concluded. Germany and the United Kingdom account for more than ninety five percent of current European sales.

Pharmaceutical company Pharmaxis (ASX: PXS) today announced positive interim results from the single ascending dose stage of the Phase 1 clinical trial for its Semicarbazide-Sensitive Amine Oxidase/Vascular Adhesion Protein-1 (SSAO/VAP-1) Inhibitor PXS4728A.

The single ascending dose stage was conducted in 48 healthy subjects divided into groups with each taking a single dose ranging from 1mg to 20mg or placebo.  There were no safety concerns in patients receiving PXS4728A, and the Phase 1 study has now progressed into the multiple ascending dose stage where 24 subjects will be split into three groups and receive a dose of either active or placebo daily for 14 days.  Three different dosages of PXS4728A will be trialled.

The single ascending dose stage of the trial also confirmed that PXS4728A is orally bioavailable and that after a single dose it produces long lasting inhibition of the SSAO/VAP-1 enzyme.