Dimerix and FUSO: A Strategic Partnership for DMX-200 in Japan
DXB (DXB) Share Update January 2025 Monday 6th
Dimerix and FUSO Partner to Bring DMX-200 to Japan
Dimerix Limited and FUSO Pharmaceutical Industries have announced an exclusive agreement for the development and commercialization of DMX-200 in Japan, targeting the treatment of Focal Segmental Glomerulosclerosis (FSGS).
Instant Summary:
- FUSO acquires exclusive rights to develop and commercialize DMX-200 in Japan.
- Dimerix to receive up to ¥10.5 billion in payments and royalties.
- FUSO responsible for all clinical trial costs in Japan.
- ACTION3 trial approved by Japanese PMDA, with sites opening soon.
- Dimerix retains rights outside Japan, continuing global Phase 3 trials.
Agreement Overview
Dimerix Limited and FUSO Pharmaceutical Industries have entered into an exclusive development and license agreement for DMX-200, a promising treatment for Focal Segmental Glomerulosclerosis (FSGS), in Japan. This partnership grants FUSO the rights to develop, register, and commercialize DMX-200 in Japan, while Dimerix retains rights for other territories.
Financial Terms and Responsibilities
Under the agreement, Dimerix will receive up to ¥10.5 billion (approximately AU$107 million) through upfront payments, development, and sales milestones. This includes an initial payment of ¥300 million (AU$3.1 million) within 40 days of the agreement, and a further ¥400 million (AU$4.1 million) upon the initiation of the first clinical trial site in Japan, expected in Q1 2025.
FUSO will handle all clinical trial costs in Japan, while Dimerix will cover costs outside of Japan. Additionally, Dimerix is eligible for royalties ranging from 15% to 20% on net sales of DMX-200 in Japan.
Clinical Trials and Regulatory Approval
The ACTION3 clinical trial has received approval from the Japanese Pharmaceutical and Medical Device Agency (PMDA). The trial will open sites in Japan to recruit approximately 20 patients, supporting potential approval in the country. This trial is part of a global Phase 3 study involving DMX-200, which aims to provide a new treatment option for FSGS, a rare kidney disease with limited current treatments.
Strategic Implications
This agreement marks the third licensing deal for DMX-200, following partnerships with Advanz Pharma and Taiba. Collectively, these deals could bring up to AU$458 million in payments and royalties for Dimerix. The partnership with FUSO highlights the significant potential of DMX-200 and Dimerix's capabilities in drug development.
The partnership with FUSO is expected to positively impact Dimerix's stock, as it secures significant financial milestones and royalties. It also strengthens Dimerix's position in the Japanese market, leveraging FUSO's expertise in pharmaceutical development and marketing. The approval of the ACTION3 trial by the PMDA further enhances the credibility and potential success of DMX-200 in Japan.
Investor Reaction:
Analysts are likely to view this partnership positively, given the substantial financial terms and the strategic expansion into the Japanese market. The involvement of FUSO, a reputable pharmaceutical company, adds confidence in the successful commercialization of DMX-200.
Conclusion:
Investors should consider the long-term potential of Dimerix's strategic partnerships and the promising outlook for DMX-200 in treating FSGS. Monitoring the progress of the ACTION3 trial and subsequent market developments will be crucial for assessing the investment potential.