On the 24th, AnnJi Pharmaceutical announced that it has signed a “License Termination and Program Transfer Agreement” with U.S.-based Avenue Therapeutics, Inc. Upon execution of the agreement, Avenue will immediately and unconditionally withdraw its arbitration claim previously filed with the International Chamber of Commerce (ICC).
AnnJi originally signed an exclusive licensing agreement with Avenue on February 28, 2023, granting Avenue the rights to develop and commercialize AJ201 for the treatment of spinal and bulbar muscular atrophy (SBMA, also known as Kennedy’s disease in the U.S.) in the United States, Canada, the European Union, the United Kingdom, and Israel.
Over the past two years, Avenue has paid AnnJi US$12.5 million and advanced AJ201 from Phase 1 clinical trials to the completion of Phase 2a trials in SBMA patients. The collaboration between the two companies has been highly synergistic, including the co-development of an assay to analyze mutant androgen receptors (mAR), marking the world’s first application of mAR testing in SBMA clinical trials, and exploring its potential as a future clinical biomarker. These significant clinical milestones have further elevated the asset value and market outlook for AJ201.
AnnJi stated that following the termination of the licensing agreement, it will fully assume global development and commercialization of AJ201. Both parties have agreed to jointly share future development risks and profits of AJ201.
Under the terms of the new agreement, AnnJi will pay Avenue a signing fee of US$2 million, along with future milestone payments for development, sublicensing, and commercialization, including sales-based royalties. The total development milestone payments due from the agreement signing through to U.S. marketing authorization will not exceed US$5 million.
The aforementioned sublicensing payments, sales milestones, and royalties will depend on whether AnnJi enters into a new licensing agreement with a future partner for AJ201. In such a case, Avenue will be entitled to a share of revenue based on development progress and product sales within the originally licensed territories. Additionally, under this agreement, Avenue will repurchase all of its common shares currently held by AnnJi.
AnnJi Chairperson and CEO Wendy Huang stated that the agreement was reached in a spirit of mutual trust and good-faith negotiation, representing a strategic transition and renewed commitment to the successful development of AJ201. AnnJi remains open to future global licensing opportunities and partnership discussions based on the positive clinical data obtained thus far.
AnnJi’s innovative pipeline has received repeated national recognition. Its lead candidate, AJ201, has been honored with the National Innovation Award and the National Innovation and Advancement Award for two consecutive years. The clinical Phase 1b/2a trial has been completed, and results are pending unblinding. Another candidate, AJ302, developed for chemotherapy-induced peripheral neuropathy, also received the National Innovation Award – Corporate Innovation Category last year and is currently in Phase 1 clinical trials in the U.S. Meanwhile, AJ303, developed for the rare disease idiopathic pulmonary fibrosis, was awarded the Boehringer Ingelheim Grass Roots Innovation Program Award, showcasing AnnJi’s outstanding strategic focus and R&D capabilities.
Wendy Huang emphasized that AnnJi remains committed to its mission of developing novel therapies that benefit patients in Taiwan and around the world. With over 40 years of experience in new drug development and licensing with international pharmaceutical companies, the company continues to drive innovation in first-in-class and best-in-class small molecule drug development. AnnJi’s management team will actively pursue global partnerships and commercial collaborations to expand treatment options and maximize shareholder value.
Resource: 安基生技與美國Avenue Therapeutics中止新藥授權協議
