BOEHRINGER Ingelheim has recently acquired the investigational drug PXS4728A discovered by Pharmaxis (ASX: PXS) in line with plans to develop it for the treatment of the liver-related condition NASH and prevent its consequences.
NASH is the progressive form of non-alcoholic fatty liver disease (NAFLD), the most common liver disorder in Western industrialized nations.
Under the agreement, Boehringer Ingelheim
will oversee all development, regulatory, manufacturing, and commercialization activities. The company has also acquired other SSAO/VAP-1 inhibitor molecules related to PXS4728A and associated patents.
Australian pharmaceutical company Pharmaxis
will receive an upfront payment of €27.5 million (approximately A$39m). Subject to the continuing successful development and commercialization of the PXS4728A program, it will also receive €55 million in development milestone payments tied to the commencement of phase 2 and 3 clinical trials, and up to €140 million in regulatory milestone payments upon filing of applications for marketing approval and receipt of regulatory and pricing approvals for a PXS4728A program product in major pharmaceutical markets such as the US, EU, and China or Japan for the first indication. .
Pharmaxis could also receive additional milestone payments similar in total to those set forth above upon achievement of the same development and regulatory milestone events by a PXS4728A program product for a second indication depending on the continued success of the program. The company could also obtain earn-out payments on annual net sales of PXS4728A program products at tiered percentages starting in the high single digits, and commercialization milestone payments upon achievement of specified levels of annual net sales of PXS4728A program products.
PXS4728A is a Semicarbazide-Sensitive Amine Oxidase/Vascular Adhesion Protein-1 (SSAO/VAP-1) Inhibitor that blocks leucocyte adhesion and tissue infiltration in inflammatory processes. Development work by Pharmaxis through phase 1 clinical studies demonstrates oral bioavailability, long-lasting target inhibition, and good tolerability and safety.
NASH is regarded as a major cause of fibrosis and cirrhosis of the liver and is an area of high unmet clinical need. With the high prevalence of type 2 diabetes and obesity, which can lead to NASH and its long term consequences, the disease is considered one of the most common causes of advanced liver disorders in the future.
Pharmaxis CEO Gary Phillips said the acquisition is a transformational event for his company.
“With a total potential value in excess of $A750 million, it is a globally competitive deal and significant for the Australian biotech sector. We are delighted that Boehringer Ingelheim, a leader in cardiometabolic research and development, has acquired PXS4728A. Boehringer Ingelheim's clinical expertise will now be applied to the development of this drug which has the potential to make a real difference in the treatment of diseases with high unmet clinical need."
According to Glyn Parkin, Corporate SVP and Metabolism head at Boehringer Ingelheim, "We have ambitious strategic goals in diabetes and metabolism and this Phase 1 asset acquisition fits well into our development portfolio. We are pleased to have achieved access to Pharmaxis' research excellence and innovative approach to treatments for NASH. We will continue to build our portfolio through both internal and external innovation so that we are able to bring much needed medications to the patients we serve."
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