First DMX-200 Patents To Grant In Europe And Canada

Dimerix is a biopharmaceutical company developing innovative new therapies in areas with unmet medical needs Dimerix HQ 425 Smith St, Fitzroy 3065 Victoria, Australia T. 1300 813 321 E. [email protected] For Immediate Release FIRST DMX-200 PATENTS TO GRANT IN EUROPE AND CANADA • First European grant of a patent for EP2663304 will provide protection for DMX-200 until at least 2032; • First Canada patent granted for patent number CA2821985 covering DMX -200 until at least 2032; • The European and Canadian patents will join corresponding patents in Australia, New Zealand and the USA, providing significant commercial protection in some of the world’s largest kidney disease markets MELBOURNE, Australia, 11 July 2019: Dimerix Limited (ASX: DXB), a clinical -stage biopharmaceutical company, announced it has received a granted patent by the Canad ian Intellectual Property Office, as well as a Notice of Intention to Grant a European patent by the European Patent Office , both patents covering the use of Dimerix’ clinical stage candidate, DMX-200. The grant of Canadian patent CA2821985 and the notice of intention to grant European patent EP2663304 demonstrates that global regulatory bodies continue to recognise and provide protections for the Dimerix novel pharmaceutical products. These patents will join corresponding granted patents in numerous key territories including the U nited States of America (US), with additional patent applications underway. The corresponding granted US patents cover the use of any CCR2 antagonist (e.g. DMX -200) in patients receiving any angiotensin receptor blocker (e.g. irbesartan), for various indications including kidney disease. As such, the granted patents may cover more than just DMX -200 and potentially strengthens the company's competitive position against some competitor products in development, in addition to any exclusivity period granted to the products. The granted therapeutic use patents are set to expire post 2032 (2033 in the US), and additional patent applications to extend this date are expected to be filed in due course. The current intellectual property strategy is very much aligned with the Dimerix business strategy and objectives. Dimerix continuously monitors the competitive landscape to identify, assess and minimise any IP risks, and to strengthen the Dimerix IP position. Dimerix is a biopharmaceutical company developing innovative new therapies in areas with unmet medical needs Dimerix HQ 425 Smith St, Fitzroy 3065 Victoria, Australia T. 1300 813 321 E. [email protected] For further information, please visit our website at www.dimerix.com or contact: Dr Nina Webster, Dimerix Limited Chief Executive Officer & Managing Director Tel: +61 1300 813 321 E: [email protected] —END— About Dimerix Dimerix (ASX: DXB) is a clinical-stage biopharmaceutical company developing innovative new therapies in areas with unmet medical needs for global markets. Dimerix is currently developing its proprietary product DMX -200 for both Diabetic Kidney Disease and Focal Segmental Glomerulosclerosis (FSGS). DMX -200 was identified using Dimerix’ proprietary assay, Receptor Heteromer Investigation Technology (Receptor -HIT), which is a scalable and globally applicable technology platform enabling the understanding of re ceptor interactions to rapidly screen and identify new drug opportunities. Receptor-HIT is licensed non -exclusively to Excellerate Bioscience, a UK -based pharmacological assay service provider with a worldwide reputation for excellence in the field of mole cular and cellular pharmacology. About DMX-200 DMX-200 is the adjunct therapy of a chemokine receptor (CCR2) antagonist administered to patients already receiving irbesartan, an angiotensin II type I (AT1) receptor blocker and the standard of care treatme nt for kidney disease. DMX-200 has granted patents in various territories until 2032. In 2017, Dimerix completed its first Phase 2a study in patients with a range of chronic kidney diseases. No significant adverse safety events were reported, and all study endpoints were achieved. In a subsequent sub -group analysis, significant clinical efficacy signals were seen in the diabetic group. DMX-200 administered to patients already taking irbesartan reduced proteinuria levels by a further 36%. This reduction in proteinuria is highly correlated with improved renal function and delay in kidney failure and dialysis. The compelling results from this study prompted the decision to initiate two different clinical studies in 2018: one for patients with Diabetic Kidney Di sease; and the second for patients with another form of kidney disease, Focal Segmental Glomerulosclerosis (FSGS). FSGS is a serious and rare disease that attacks the kidney’s filtering units (glomeruli) causing serious scarring which leads to permanent kidney damage and kidney failure and for which there is a recognised medical need for a new or improved treatment. FSGS affects both children and adults. DMX-200 for FSGS has been granted Orphan Drug Designation by the FDA and EMA. Orphan Drug Designation is granted to support the development of products for rare diseases and qualifies Dimerix for various development incentives including: seven years (FDA) and ten years (EMA) of market exclusivity if regulatory approval is received, exemption from certain application fees, and an abbreviated regulatory pathway to approval.

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