Dimerix will retain all commercialisation rights for DMX-200 in all other unlicensed territories for treating FSGS kidney disease. Credit: Ground Picture / Shutterstock.com.

Dimerix has entered into an exclusive licensing agreement worth up to nearly A$120.5m ($79.8m) with Taiba to commercialise its drug candidate, DMX-200, for treating focal segmental glomerulosclerosis (FSGS) kidney disease in the Middle East.

The agreement covers seven Middle East countries, including the United Arab Emirates, Saudi Arabia, Oman, Kuwait, Qatar, Bahrain and Iraq.

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Under the terms of the agreement, Dimerix will receive an upfront payment of approximately $350,000 (A$0.51m) from Taiba within 30 days.

Additionally, Dimerix is entitled to receive up to AU$120m ($80.4m) in milestone payments, plus royalties on net product sales, on the successful commercialisation of DMX-200 in the region.

Dimerix will retain all commercialisation rights for DMX-200 in all other unlicensed territories, including the US and China.

The company will continue to provide funding and carry out the global Phase III ACTION3 trial in FSGS patients, while Taiba will handle regulatory submissions and marketing in its licensed territories.

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Taiba will also oversee the complete sales and expenditures linked to the marketing of the product.

The partnership will also establish a Joint Steering Committee to oversee the development and commercialisation of DMX-200 in the Middle East.

Furthermore, Taiba has the option to negotiate a license for additional indications of DMX-200 that Dimerix may develop.

This deal follows the report of successful interim analysis data from the global ACTION3 Phase III study of DMX-200 in March this year.

Taiba is the second company to license DMX-200, following a deal with Advanz Pharma executed in October last year.

Together, these agreements provide Dimerix with nearly A$11.5m in upfront payments and the potential for up to A$340m in milestone payments, in addition to royalties.

Taiba ME CEO Dr Saif Al Hasani said: “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).”