• Dimerix enters exclusive licence deal with Fuso Pharmaceutical Industries to develop and commercialise DMX-200 in Japan to treat FSGS
  • Fuso responsible for development costs, obtaining regulatory approval, sales and marketing in Japan
  • Deal worth upwards of A$100 million for Dimerix with first payment of ~$3.1 million

 

Special Report: Dimerix has inked an exclusive development and license agreement for development and commercialisation of its ACTION3 phase III drug candidate DMX-200 to treat focal segmental glomerulosclerosis (FSGS) kidney disease with Fuso Pharmaceutical Industries Pty Ltd in Japan.

Clinical-stage biotech Dimerix (ASX:DXB) will continue to fund and execute the global ACTION3 phase III study for DMX-200 in FSGS patients outside of Japan.

Fuso will be responsible for all development costs, submission and maintenance of the regulatory dossier with the Japanese Pharmaceutical and Medical Device Agency (PMDA), as well as all sales and marketing activities in Japan.

Dimerix said in exchange for these rights it will receive a payment of ¥300 million (~A$3.1m) within 40 days of executing the agreement, ¥400m (~A$4.1m) on initiation of the first clinical trial site, which is anticipated in Q1 CY25, plus potential development and commercialisation milestones of up to ¥9.8 billion (~A$100m).

In addition, Dimerix is eligible to receive royalties of between 15-20% on net sales of DMX-200 if successfully commercialised.

 

Interim analysis forecast in August for rare disease

This ACTION3 phase III trial is a randomised, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker (ARB).

Planned blinded interim data collection is anticipated in August 2025, following 35 weeks of dosing of the first 144 patients.

FSGS attacks the kidneys and results in irreversible scarring, leading to permanent kidney damage and eventually end-stage kidney failure, requiring dialysis or transplantation.

The disease impacts both adults and children as young as two years old, with no drugs currently approved specifically for its treatment worldwide, significantly restricting available options and affecting overall prognosis.

Consequently, DMX-200 has been granted Orphan Drug Designation in the US and Europe, as well as the equivalent Innovative Licensing and Access Pathway (ILAP) designation in the UK.

 

Third licensing deal for Dimerix

Fuso is the third licensing deal executed for DMX-200. Dimerix announced a licensing deal in October 2023 with Advanz Pharma covering the European Economic Area, UK, Switzerland, Canada, Australia and New Zealand for commercialisation of DMX-200 for the treatment of FSGS following regulatory approval.

The company also announced a licensing deal with Taiba in May 2024 for several Middle Eastern countries including the United Arab Emirates (UAE), Saudi Arabia, Oman, Kuwait, Qatar, Bahrain and Iraq.

Dimerix said collectively the licensing deals provide up to ~AU$458 million in upfront payments and potential milestone payments, plus royalties on net sales.

The company retains all rights to commercialise DMX-200 in all territories other than those covered by the Fuso, Advanz Pharma, and Taiba license agreements.

 

Fuso honoured by ‘truly valuable opportunity’

Fuso president and representative director Mikio Toda said the company was greatly honoured to be involved in development of a new drug for the rare kidney disease, with ~1400 patients having received treatment in Japan in 2023.

“It is a truly valuable opportunity for us to partner with Dimerix, which also has an innovative technology called Receptor-HIT, and we will work together with Dimerix to do our best to quickly deliver safe and effective new drugs to patients suffering from FSGS,” Toda said.

Dimerix CEO and managing director Dr Nina Webster said the company was delighted to partner with Fuso for the commercialisation of DMX-200 in Japan.

“Fuso brings a wealth of experience in pharmaceutical development and sales and marketing across Japan, and with a proven record in sales and marketing products for patients with renal disease,” Webster said.

“This partnership reflects a confidence not only in the significant potential for DMX-200 in FSGS patients but also in Dimerix’s capabilities in the development of DMX-200.

“Fuso’s expertise and resources will be invaluable in supporting Dimerix to advance our shared goal of developing and commercialising DMX-200 and bringing hope to those patients desperately in need of treatment options.”

 

 

 

This article was developed in collaboration with Dimerix, a Stockhead advertiser at the time of publishing.

 

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.