Dimerix strikes $120m licensing deal for kidney drug in Middle East. Image: Getty.
Health & Biotech
Special Report: Dimerix will receive up to $120.5m after inking an exclusive license agreement for the commercialisation of its Phase 3 kidney disease drug candidate DMX-200 in several Middle Eastern countries.
Clinical-stage biopharmaceutical company Dimerix (ASX:DXB) says Taiba has acquired the exclusive rights to register and commercialise 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.
Under the deal DXB will receive up to US$80.4m (~A$120.5m) from Taiba in upfront and milestone payments on certain development and sales milestones being achieved.
The company will also receive tiered royalties starting at 30% on net sales.
Taiba also has a right to negotiate a license to develop and commercialise DMX-200 in any additional indications in the licensed territories that DXB may achieve for DMX-200.
The minimum term for the deal is 15 years, or until the last valid patent claim covering the product expires. DXB retains all rights to commercialise DMX-200 in all other unlicensed territories, including the US and China.
Established in 1980, privately owned Taiba 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 portfolio of medicines.
DXB says Taiba’s focus and extensive experience in bringing innovative medicines to patients in the Middle East makes them an outstanding partner for the potential commercialisation of DMX-200 in the UAE, Saudi Arabia, Oman, Kuwait, Qatar, Bahrain and Iraq.
DXB says in countries across the Middle East, such as Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and the UAE, citizens typically have free, government-sponsored access to healthcare and any treatments that become available for their diseases.
Across the majority of the Middle East, prices of an orphan disease drug are also commonly set according to either the price in the country of origin or the price of the approved product in the US or Europe.
DXB says 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.
The two companies will form a joint steering committee to align the development and commercialisation of DMX-200 in FSGS in the territories.
Taiba is the second license deal executed for DMX-200 following the license deal with multinational pharmaceutical company Advanz Pharma, announced in October 2023, worth A$230m in upfront and milestone payments, plus royalties.
The previous deal with Advanz covers the European Economic Area, UK, Switzerland, Canada, Australia, and New Zealand for commercialisation of DMX-200 for the treatment of FSGS following regulatory approval.
In September 2023 the FDA granted DXB conditional approval for the brand name QYTOVRA for its DXB-200.
DXB says it continues to negotiate with potential licensees outside the Taiba and Advanz Pharma territories with a key focus being the major markets of US and China, including on various non-binding term sheets it has received for licensing opportunities.
The Taiba licensing deal follows highly anticipated interim analysis results announced in March from its ACTION3 Phase 3 trial of DMX-200 in patients diagnosed with FSGS demonstrating the achievement of its primary endpoint.
The Phase 3 trial achieved success in its pre-specified interim analysis of the proteinuria (efficacy) endpoint, based on data from the initial 72 randomised patients.
The interim analysis indicates that DMX-200 is currently outperforming the placebo in reducing proteinuria, as measured statistically, within a significantly larger participant group compared to its earlier Phase 2 trial involving eight patients.
DXB says the interim analysis suggests the potential for a statistically significant and clinically meaningful reduction in proteinuria at the study’s conclusion.
Moreover, the trial’s Independent Data Monitoring Committee (IDMC) affirmed no safety concerns related to DMX-200, further enhancing the drug’s safety profile.
DXB’s ACTION3 clinical trial has now formally expanded into Part 2 of the study and to April 30, 2023, had randomised and dosed 98 patients with FSGS.
The second interim analysis is planned to be carried out after the first 144 patients complete about 35 weeks of treatment.
DXB CEO and managing director Dr Nina Webster says the company is very pleased to 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,” she says.
“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.”
Taiba CEO Dr Saif Al Hasani says the company is thrilled to partner with DXB 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,” Al Hasani says.
“Our dedication to collaborating with Dimerix underscores our commitment to bringing hope to patients with rare disease conditions such as FSGS.”
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.
Health & Biotech
Health & Biotech
Health & Biotech
