Posted: 28 May 2024
Dimerix Limited (ASX: DXB, “Dimerix”) and Taiba Middle East FZ LLC, (“Taiba”), today announced that they have entered into an exclusive license agreement for the commercialisation of Dimerix’ Phase 3 drug candidate DMX-200 for the treatment of focal segmental glomerulosclerosis (FSGS) kidney disease in the United Arab Emirates (UAE), Saudi Arabia, Oman, Kuwait, Qatar, Bahrain and Iraq. Dimerix retains all rights to commercialise DMX-200 in all other unlicensed territories, including the US and China.
In countries across the Middle East, such as Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and the United Arab Emirates, citizens typically have free, government-sponsored access to healthcare and any treatments that become available for their diseases. 4 Furthermore, across the majority of the Middle East, the prices of an orphan disease drug are commonly set according to either the price in the country of origin or the price of the approved product in the US or Europe. 5 As such, in the case DMX-200 is commercialised with orphan drug status, the price would be expected to be based in line with the US Food and Drug Administration (FDA) or European Medicines Agency (EMA) pricing model.5
Established in 1980, Taiba Middle East FZ LLC is a privately owned company and was the first company 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 to the Middle East with a diverse, innovative portfolio and a strong focus on access to health for patients. Taiba’s focus and extensive experience in bringing innovative medicines to patients in the Middle East makes them an outstanding partner for Dimerix in the potential commercialisation of DMX-200 in the United Arab Emirates (UAE), Saudi Arabia, Oman, Kuwait, Qatar, Bahrain and Iraq.
Dimerix will continue to fund and execute the global ACTION3 Phase 3 study for DMX-200 in FSGS patients, and Taiba will be responsible for 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$350,0002 (~AU$0.5 1 million) within 30 days. Furthermore, Dimerix is eligible to receive potential payments of up to US$80.4 million (~AU$1201 million) on certain development and commercialisation milestones being achieved and tiered percentage royalties starting at 30% and decreasing by 5% every 5 years down to 20% on net sales of DMX-200 in the region, if successfully commercialised (all contracted financial terms are denominated in US$).
Dimerix and Taiba will form a Joint Steering Committee to align the development and commercialisation of DMX-200 in FSGS in the territories. Taiba also has a right to negotiate a license to develop and commercialize DMX-200 in any additional indications in the licensed territories that Dimerix may achieve for DMX-200. The minimum term is 15 years, or until the last valid patent claim covering the product expires (whichever is the latest). The agreement otherwise contains terms common for an arrangement of this kind, including termination provisions that, amongst other matters, allows for Taiba to terminate on 180 days’ notice.
Following on from Dimerix’ successful interim analysis of DMX-200 in its global ACTION3 Phase 3 study for FSGS (announcement 11 March 2024), Dimerix now has two high quality partners across multiple territories, providing strong support for Dimerix in advancing and commercialising DMX-200 as a potential new treatment for FSGS. Collectively across both licences, Dimerix may become eligible for an additional up to AU$340 million1 in milestone payments, in addition to royalties on net sales. Dimerix continues to negotiate the non-binding term sheets received for licensing opportunities with potential partners outside the Taiba (United Arab Emirates (UAE), Saudi Arabia, Oman, Kuwait, Qatar, Bahrain and Iraq) and Advanz Pharma (EEA, Canada, Switzerland, UK, Australia and New Zealand) territories, with a key focus being the major markets of US and China.
