Highlights:
Dimerix receives an upfront payment from FUSO Pharmaceutical Industries for the development and commercialization of DMX-200.
The agreement includes additional development and sales milestone payments, along with royalties on net sales.
Additional licensing agreements with Advanz Pharma and Taiba expand commercialization across multiple regions.
Dimerix (ASX:DXB), a biopharmaceutical company, has entered a licensing agreement with Japan-based FUSO Pharmaceutical Industries for the development and commercialization of DMX-200. The company has received an initial payment as part of the agreement, which focuses on treating focal segmental glomerulosclerosis (FSGS), a serious kidney condition.
Development and Commercialization Milestones
The agreement grants FUSO exclusive rights to commercialize DMX-200 within Japan. Additional payments will be provided upon reaching key development milestones, alongside financial incentives tied to sales performance. A structured royalty percentage is included in the agreement based on net sales upon successful commercialization.
Clinical Progress and Expansion in Japan
The ACTION3 phase III clinical trial, designed to evaluate DMX-200’s efficacy in treating FSGS, is progressing with site identification in Japan. The trial follows a double-blind, placebo-controlled format. Interim data from the study is anticipated within the next eighteen months. The condition affects both children and adults, leading to progressive kidney damage.
Broader Licensing Agreements
Beyond Japan, Dimerix has secured additional licensing agreements to expand DMX-200’s reach. A collaboration with Advanz Pharma includes territories such as Europe, Canada, and Australasia, while an agreement with Taiba extends into Middle Eastern regions. Collectively, these partnerships contribute to the broader commercialization of the treatment.
Regulatory Designations and Market Presence
DMX-200 has been granted Orphan Drug Designation in the United States and Europe, with additional designations in the United Kingdom. These regulatory acknowledgments reinforce the commitment to advancing treatment options for FSGS. Ongoing strategic licensing discussions continue to focus on expanding into other key markets, including the United States and China.