Dimerix (DXB: $0.56) announced an exclusive license agreement with Taiba to commercialise DMX-200 in seven Middle Eastern countries.
Strategic partnership
Taiba acquired exclusive rights to register and commercialise DMX-200 for the treatment of focal segmental glomerular sclerosis (FSGS), a disease that scars the kidney filtration units.
The licensed countries include the United Arab Emirates (UAE), Saudi Arabia, Oman, Kuwait, Bahrain, Qatar, and Iraq. Taiba will also be responsible for the sales and costs of marketing.
Taiba was the first country to focus on drugs for rare diseases in the Middle East. In these countries patients receive free healthcare with pricing of therapies similar to that in major markets. The countries also piggyback on the regulatory approval processes from the US, Europe and Australia which will help Dimerix achieve faster market access.
Dimerix expects to receive an upfront payment of $0.5 million and up to A$120 million of milestone payments plus royalties on net sales starting at 30%.
This deal follows Dimerix's 2023 licensing of DMX-200 to Adanvz Pharma in the EEA, Canada, the UK, Switzerland Australia and New Zealand for an upfront payment of $10.8 million and milestone payments of up to $219 million.
Phase III ACTION3 trial
Dimerix is conducting a double-blinded PIII clinical trial (NCT05183646) for FSGS, in 276 patients.
The March 2024 interim data point indicated that DMX-200 could produce a statistically significant and clinically meaningful results with no safety issues so far. The second interim analysis, from 144 patients, is due mid-2025.So far at least 100 patients have been recruited across 70 sites in 11 countries.
Future of DMX-200
Dimerix retains all rights to commercialise DMX-200 in unlicensed territories. It continues to target the world's major markets such as the US and Japan as well as China and Latin America. DMX-200 has received Orphan Drug Designation by the EMEA & FDA, with there being no approved therapy for FSGS.
Dimerix estimates that the FSGS market size is approximately 303,000 patients across China and the seven major markets (7MM). Dimerix estimates that FSGS is a potential billion-dollar plus market.
The second licensing deal by Dimerix highlights the commercial interest in its lead compound DMX-200. Extensive due diligence was conducted by Advanz and presumably by its most recent partner Taiba, which bodes well for additional licensing deals.
Dimerix's share price increased by $0.28 per share from the first deal (with Advanz) and by $0.22 following the second deal (with Taiba). Its market capitalisation has increased from just $24 million at the end of June last year to now $307 million. The company held cash of $35 million at the end of March.
Bioshares recommendation: Speculative Buy Class A
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