Dimerix and FUSO Enter Into Exclusive Development and License Agreement to Commercialize DMX-200 in Japan

Key Highlights

• FUSO acquires exclusive rights to develop, register, and commercialize DMX-200 for the treatment of Focal Segmental Glomerulosclerosis (FSGS) in Japan.
• FUSO assumes responsibility for all clinical trial costs in Japan, while Dimerix retains responsibility outside of Japan.
• Dimerix (ASX: DXB) is poised to receive up to ¥10.5 billion (~AU$107.1 million) in upfront, development, and sales milestone payments, alongside 15-20% royalties on net sales.
• The ACTION3 clinical trial has been approved by the Japanese Pharmaceutical and Medical Device Agency (PMDA).
• This deal marks the third license agreement for DMX-200, after Advanz Pharma (October 2023) and Taiba (May 2024).
• DMX-200 is in global Phase 3 clinical development for FSGS, a rare kidney disease affecting over 220,000 people worldwide.

Overview

In an exciting new partnership, Dimerix Limited (ASX: DXB) has entered into an exclusive agreement with FUSO Pharmaceutical Industries for the commercialization of DMX-200, Dimerix's (ASX: DXB) promising drug candidate for the treatment of Focal Segmental Glomerulosclerosis (FSGS), in Japan.

This agreement signifies a strategic move for both companies in the rapidly expanding field of renal disease treatments. With FUSO’s deep knowledge and experience in Japan’s pharmaceutical market, especially in renal treatments, the partnership aims to bring a new hope for patients suffering from this rare and severe kidney disease.

Dimerix (ASX: DXB), an innovative biopharmaceutical company focused on kidney diseases and inflammatory disorders, will continue to oversee global development of DMX-200. Meanwhile, FUSO takes charge of all regulatory, clinical, and commercial responsibilities within Japan, including the ACTION3 Phase 3 clinical trial, which has already been approved by Japan’s PMDA.

Key Financial Terms of the Agreement

The collaboration comes with significant financial commitments, demonstrating the potential of DMX-200 in the Japanese market. Dimerix (ASX: DXB) will receive the following:

• ¥300 million (~AU$3.1 million) upon execution of the agreement.
• ¥400 million (~AU$4.1 million) on initiation of the first clinical trial site in Japan (expected in Q1 2025).
• Up to ¥3 billion (~AU$30.6 million) in potential development milestones.
• Potential sales milestones of up to ¥6.8 billion (~AU$69.4 million).
• Royalties of 15-20% on net sales, should DMX-200 be successfully commercialized in Japan.

With these payments structured around key clinical and regulatory milestones, the deal offers a mutually beneficial framework that allows Dimerix (ASX: DXB) to retain ownership of DMX-200 in all regions outside of the exclusive territories held by FUSO, Advanz Pharma, and Taiba.

Clinical Trials and Market Potential

The ACTION3 Phase 3 clinical trial for DMX-200 is already in progress, with over 1,400 patients enrolled globally, including Japan. FSGS, a rare kidney disease characterized by scarring of the glomeruli (the filtering units of the kidney), has no approved treatments globally.

DMX-200, a combination of a CCR2 antagonist and an AT1R blocker, represents a novel approach to managing this devastating condition. The drug has already shown promising results in Phase 2 trials for both FSGS and diabetic kidney disease.

Dimerix's (ASX: DXB) Receptor-HIT technology has enabled the discovery of DMX-200, providing new hope for patients suffering from chronic kidney disease. The company’s cutting-edge approach holds promise not just for FSGS, but also for other inflammatory diseases, such as respiratory conditions, through its DMX-700 development program.

Expert Commentary

Mikio Toda, President of FUSO, expressed his excitement about the partnership, stating, "We are greatly honored to be involved in the development of a new drug for FSGS, as there are currently no approved drugs for the treatment of this disease. Partnering with Dimerix, which has innovative technology like Receptor-HIT, is a valuable opportunity to make a significant impact on patients’ lives."

Dr. Nina Webster, CEO of Dimerix (ASX: DXB), echoed these sentiments, highlighting the importance of FUSO's expertise in the Japanese pharmaceutical market. "We are thrilled to collaborate with FUSO to commercialize DMX-200 in Japan. This partnership reflects confidence not only in DMX-200’s potential but also in Dimerix’s ability to develop and advance the treatment," said Dr. Webster.

Joint Steering Committee and Future Opportunities

Both companies will establish a Joint Steering Committee to oversee the development and commercialization of DMX-200 in Japan. Any data generated by FUSO during the trial and regulatory processes will also be made available to Dimerix for use in territories outside Japan, strengthening the global potential of DMX-200.

FUSO also has the option to negotiate a license for additional indications for DMX-200 in Japan. As such, this agreement opens doors for future developments and expansions of the drug’s use, further solidifying the partnership's long-term value.

In addition to the agreement with FUSO, Dimerix (ASX: DXB) is actively pursuing licensing opportunities for DMX-200 in other global markets, including the United States and Mainland China. With the latest partnership, Dimerix (ASX: DXB) is well-positioned to expand its footprint in the kidney disease treatment market, which is valued at over $1 billion annually.

About Dimerix

Dimerix (ASX: DXB) is a clinical-stage biopharmaceutical company focused on developing novel therapies for kidney diseases and other inflammatory disorders. Its flagship drug, DMX-200, is currently in Phase 3 trials for FSGS, and the company is also advancing DMX-700 for respiratory conditions. Dimerix’s (ASX: DXB) proprietary Receptor-HIT platform enables the discovery of drugs with significant potential to address unmet medical needs across various therapeutic areas.

About FUSO Pharmaceutical Industries, Ltd

FUSO Pharmaceutical Industries is a leading Japanese pharmaceutical company specializing in renal and urology treatments. As a pioneer in the development of dialysis solutions and other critical medical products, FUSO has been at the forefront of improving healthcare for patients with kidney disease in Japan. The company is committed to addressing unmet medical needs through innovative solutions and a patient-centered approach.

Looking Ahead

The agreement between Dimerix and FUSO marks a critical step in the commercialization of DMX-200 for FSGS in Japan. With FUSO’s market experience and Dimerix’s (ASX: DXB) cutting-edge drug development, this partnership holds great promise for the treatment of FSGS, a condition that affects thousands of people globally. The deal sets the stage for significant advancements in the treatment of kidney diseases, with the potential for additional licensing opportunities in other regions.