Date: 2018-01-11
Type of information: Milestone
Compound: PXS4728A/BI 1467335
Company: Boehringer Ingelheim (Germany) Pharmaxis (Australia)
Therapeutic area: Liver diseases - Hepatic diseases - Inflammatory diseases - Pulmonary diseases - Respiratory diseases
Type agreement: licensing - development - production - manufacturing - commercialisation
Action mechanism:
- protein inhibitor/vascular adhesion protein-1 (VAP-1) inhibitor. PXS4728A is a highly selective oral small molecule inhibitor of vascular adhesion protein-1 that has shown activity in preclinical investigation in non-alcoholic steatohepatitis (NASH). This inhibitor 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.
Disease: NASH (non-alcoholic steatohepatitis) chronic obstructive pulmonary disease (COPD)
Details:
- • On May 18, 2015, Boehringer Ingelheim and Pharmaxis announced 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. 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. A phase 1 trial is currently ongoing.
• On March 12, 2015, Pharmaxis announced it has signed an Option and Asset Purchase Agreement with Boehringer Ingelheim for the Pharmaxis Semicarbazide-Sensitive Amine Oxidase/Vascular Adhesion Protein-1 (SSAO/VAP-1) Inhibitor PXS4728A. Under the terms of the agreement Boehringer has been granted an exclusive option to acquire world?wide rights to PXS4728A and related SSAO/VAP-1 inhibitor molecules. The option provides Boehringer with the opportunity to complete its diligence assessment of PXS4728A. According to the timetable agreed between Boehringer and Pharmaxis the option is expected to expire on 15 May 2015. The fee payable to Pharmaxis for grant of the option is €1.25 million (approximately A$1.8 million). If the option is exercised, Boehringer will acquire Pharmaxis’ entire PXS4728A program including all patents and know?how, and Boehringer will then be responsible for all development, regulatory, manufacturing and commercialisation activities.
Financial terms:
- 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.
Latest news:
- • On January 11, 2018, Pharmaxis announced dosing of the first patient in Boehringer Ingelheim’s Phase 2a clinical trial in patients with diabetic retinopathy (DR), triggering a €10
million (~A$15 million) milestone payment to Pharmaxis. DR is the second disease to be targeted with BI 1467335 originally discovered by Pharmaxis. BI 1467335 is also in an ongoing Phase 2a clinical trial for non?alcoholic steatohepatitis (NASH).
- • On August 24, 2017, Boehringer Ingelheim has initiated a European and North American Phase IIa trial in NASH with BI 1467335 (formerly known as PXS?4728A). This announcement triggers the payment of an €18 million (A$27m) milestone to Pharmaxis.
Is general: Yes
