Boehringer Ingelheim exercises option and acquires global ownership of Pharmaxis’ investigational anti-inflammatory drug candidate PXS4728A, including associated intellectual property rights.
PXS4728A is a highly selective oral small molecule inhibitor of vascular adhesion protein-1 that has shown activity in pre-clinical investigation in non-alcoholic steatohepatitis (NASH).
Drug candidate will be investigated for the treatment of NASH and has further potential in chronic obstructive pulmonary disease and other diseases with high medical need.
The acquisition of this investigational anti-inflammatory drug-candidate adds a highly innovative approach to Boehringer Ingelheim’s clinical development portfolio.
Pharmaxis is transformed by significant deal size and recognition of its drug discovery expertise.
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Boehringer Ingelheim and pharmaceutical company Pharmaxis 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.
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.
Pharmaxis will receive an upfront payment of €27.5 million (approximately A$39m) and, subject to the continuing successful development and commercialisation of the PXS4728A program, the following payments:
- up to a total of €55 million in development milestone payments tied to the commencement of phase 2 and 3 clinical trials
- up to a total of €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 the major pharmaceutical markets (i.e., USA, EU, and China or Japan) for the first indication
- 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
- earn-out payments on annual net sales of PXS4728A program products at tiered percentages starting in the high single digits
- commercialisation milestone payments upon achievement of specified levels of annual net sales of PXS4728A program products
Boehringer will be responsible for all development, regulatory, manufacturing and commercialisation activities.
Under the agreement, Boehringer has also acquired other SSAO/VAP-1 inhibitor molecules related to PXS4728A and associated patents.