Dimerix (ASX:DXB) has announced an exclusive license agreement with Taiba Middle East for the commercialisation of its candidate DMX-200.
DMX-200 is in a Phase 3 trial for the treatment of focal segmental glomerulosclerosis (FSGS) kidney disease.
The agreement with Taliba included the United Arab Emirates (UAE), Saudi Arabia, Oman, Kuwait, Qatar, Bahrain and Iraq. Dimerix said it retains all rights to commercialise DMX-200 in all other unlicensed territories, including the US and China.
Established in 1980, Taiba is a privately owned company and was the first to provide medicines for rare diseases in the Middle East. Taiba has multiple subsidiary companies, including Taiba Rare LLC and Menagen Pharmaceutical Industries LLC, which focus on marketing and manufacturing therapeutics for rare diseases in the Middle East.
“We are thrilled to partner with Dimerix in launching DMX-200 in the Middle East pending FDA approval. DMX-200 will strengthen our portfolio of treatments for rare nephrology diseases, enabling us to offer a comprehensive solution for our treating physicians. Leveraging our existing network, knowledge and expertise, we aim to introduce a breakthrough medication for our patients suffering from focal segmental glomerulosclerosis (FSGS). Our dedication to collaborating with Dimerix underscores our commitment to bringing hope to patients with rare disease conditions such as FSGS,” said Taliva CEO Dr Saif Al Hasani.
Dimerix said it will continue to fund and execute the global ACTION3 Phase 3 study for DMX-200 in FSGS patients, and Taiba will be responsible for the submission and maintenance of the regulatory dossier in its licensed territories, as well as all sales and costs of marketing activities.
Dimerix will receive an upfront payment of US$350,000 within 30 days. It is eligible to receive potential payments of up to US$80.4 million (on specific development and commercialisation milestones being achieved and tiered percentage royalties starting at 30 per cent and decreasing by 5 per cent every 5 years down to 20 per cent on net sales of DMX-200 in the region if successfully commercialised.
“We are very pleased to be partnering with the Taiba group for the Middle East. The unique knowledge and expertise that the Taiba team has built in the rare disease space, as well as the established regulatory support and supply chain, places them in the ideal position to achieve the optimum outcome in the Middle East territories for all stakeholders. We very much look forward to collaborating with all our partners, as we all strive to make a difference in kidney diseases, which have such an urgent unmet need.” said Dimerix CEO and managing director Dr Nina Webster.