Dimerix enters Development and License Agreement for Japan

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Stock Dimerix Ltd (DXB.ASX)
Release Time 7 Jan 2025, 8:22 a.m.
Price Sensitive Yes
 Dimerix enters Development and License Agreement for Japan
Key Points
  • FUSO acquires exclusive rights to develop, register and commercialise DMX-200 for FSGS in Japan
  • Dimerix to receive up to ¥10.5 billion (~AU$1071 million) in upfront, development and sales milestone payments, plus royalties
  • ACTION3 clinical trial approved by the Japanese Pharmaceutical and Medical Device Agency (PMDA)
Full Summary

Dimerix Limited (ASX: DXB) and FUSO Pharmaceutical Industries, Ltd. ('FUSO') have announced an exclusive development and license agreement for the development and commercialisation of Dimerix' Phase 3 drug candidate DMX-200 for the treatment of focal segmental glomerulosclerosis (FSGS) kidney disease in Japan. Under the agreement, FUSO will be responsible for all clinical trial costs, submission and maintenance of the regulatory dossier with the PMDA, as well as all sales and marketing activities in Japan. In exchange, Dimerix will receive a payment of ¥300 million (~AU$3.1 million) within 40 days, ¥400 million (~AU$4.1 million) on initiation of the first clinical trial site, and potential development and commercialisation milestones of up to ¥9.8 billion (~AU$100 million), plus royalties of 15-20% on net sales. The ACTION3 clinical trial for DMX-200 in FSGS has been approved by the Japanese Pharmaceutical and Medical Device Agency (PMDA), and sites will open in Japan to support recruitment of approximately 20 patients. Dimerix retains all rights to DMX-200 in all territories other than those covered by the FUSO, Advanz Pharma, and Taiba license agreements.

Guidance

Dimerix will receive up to ¥10.5 billion (~AU$1071 million) in upfront, development and sales milestone payments, plus royalties of 15-20% on net sales of DMX-200 in Japan.

Outlook

The partnership with FUSO reflects confidence in the significant potential for DMX-200 in FSGS patients and Dimerix' capabilities in the development of DMX-200. FUSO's expertise and resources will be invaluable in supporting Dimerix to advance the shared goal of developing and commercialising DMX-200 and bringing hope to those patients desperately in need of treatment options.