• ADVANZ PHARMA acquires exclusive rights to register and commercialise DMX-200 for the treatment of Focal Segmental Glomerulosclerosis (FSGS) in the European Economic Area, the UK, Switzerland, Canada, Australia, and New Zealand
• Dimerix to receive up to €138.5 million in upfront and milestone payments, plus royalties, comprising of;
  • €6.5 million upfront payment
  • up to €132 million in potential further milestones
  • tiered royalties on sales
• Focal Segmental Glomerulosclerosis (FSGS) is a rare disease that causes kidney scarring and can lead to end-stage kidney disease
• DMX-200 is in development in the global ACTION3 Phase 3 clinical trial
• ADVANZ PHARMA will leverage its specialty, hospital, and rare disease expertise and commercial platform to register and effectively promote the product and offer greater patient access
• Dimerix retains all rights to DMX-200 in all other territories

London, UK – 04/10/2023: - ADVANZ PHARMA Corp. Limited (“ADVANZ PHARMA” or “the Company”), a UK headquartered global pharmaceutical company with a strategic focus on speciality, hospital and rare disease medicines in Europe, Canada, and Australia, today announced they have entered into an exclusive license agreement for the European Economic Area, the UK, Switzerland, Canada, Australia, and New Zealand for the commercialisation of Dimerix’ Phase 3 drug candidate DMX-200 for the treatment of focal segmental glomerulosclerosis (FSGS) kidney disease, following regulatory approval. Dimerix retains all rights to commercialise DMX-200 outside of these territories. DMX-200 is currently in global Phase 3 clinical development.

Dimerix will continue to fund and execute the global ACTION3 Phase 3 study for DMX-200 in FSGS patients, and ADVANZ will be responsible for submission and maintenance of the regulatory dossier in the licensed territories, as well as all sales and marketing activities. In exchange for these rights, Dimerix will receive an upfront payment of €6.5 million within 30 days, plus potential development and commercialisation milestones of up to €132 million. In addition, Dimerix is eligible to receive tiered, escalating, mid-teen to twenty percentage royalties on net sales of DMX-200 if successfully commercialised (all contracted financial terms are denominated in Euros).

Steffen Wagner, CEO, ADVANZ PHARMA, said, “We are excited to announce this partnership with Dimerix, which is fully in line with our strategy to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. We are committed to bring innovative rare disease medicines to market which serve a high unmet patient need.”

Dimerix and ADVANZ will form a Joint Steering Committee to align the development and commercialisation of DMX-200 in FSGS in the territories. Any data and regulatory filings generated by ADVANZ or Dimerix may be used by either party for the development and commercialization of DMX-200 in their respective territories. ADVANZ has a right of first offer to negotiate a license to develop and commercialize DMX-200 in any additional indications in the licensed territories.

Dimerix continues to pursue and progress licensing opportunities with potential partners outside the ADVANZ territories.

CEO & Managing Director of Dimerix, Dr Nina Webster, said, “We are delighted to be partnering with ADVANZ in Europe, UK, Australia, New Zealand and Canada. The ADVANZ team has a proven record in developing and commercialising medicines in areas with no approved therapies and high unmet needs. ADVANZ’s expertise and resources will be invaluable in supporting Dimerix to advance our shared goal of commercialising this novel treatment, and this partnership recognises the decade of work by our dedicated team, consultants, trial participants, and investigators in the developing a new therapy for patients with FSGS.”

Professor Jonathan Barratt, Nephrologist, Mayer Professor of Renal Medicine: University of Leicester, Co-Chair UK Glomerulonephritis Clinical Study Group, said, “With limited treatment options currently available and many patients who do not adequately respond to existing treatment regimes, there remains a significant unmet need for efficacious FSGS therapies Dimerix’ and ADVANZ’s commitment to DMX-200 brings us closer to the first potential treatment specifically for FSGS designed to improve the lives of those suffering from the disease”.

About ADVANZ PHARMA

Partner of choice in specialty, hospital, and rare disease medicines

ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients’ lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our headquarters are in London, UK. We have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia, a Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network. ADVANZ PHARMA’s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, oncology, CNS, and, more broadly, rare disease medicines. Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with biopharma and development companies to bring medicines to patients. We can only achieve this due to our dedicated and highly qualified employees, acting in line with our company values of entrepreneurship, speed, and integrity.

For more information, please visit our Website or LinkedIn.

About ACTION3 FSGS Phase 3 Study

The Phase 3 study, which is titled “Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2 (CCR2) Targets for Inflammatory Nephrosis”, or ACTION3 for short, is a pivotal (Phase 3), multi-centre, randomised, double-blind, placebo-controlled study of the efficacy and safety of DMX200 in patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker (ARB). Once the ARB dose is stable, patients will be randomized to receive either DMX200 (120 mg capsule twice daily) or placebo.

The single Phase 3 trial in FSGS patients has two interim analysis points built in that are designed to capture evidence of proteinuria and kidney function (eGFR slope) during the trial, aimed at generating sufficient evidence to support marketing approval.

Further information about the study can be found on ClinicalTrials.gov (Study Identifier: NCT05183646) or Australian New Zealand Clinical Trials Registry (ANZCTR) (Study Identifier ACTRN12622000066785).

About Dimerix

Dimerix (ASX: DXB) is a clinical-stage biopharmaceutical company working to improve the lives of patients with inflammatory diseases, including both kidney and respiratory diseases. Dimerix is currently focussed on developing its proprietary Phase 3 product candidate DMX-200 (QYTOVRA® in some territories), for Focal Segmental Glomerulosclerosis (FSGS) kidney disease, and is also developing DMX-700 for Chronic Obstructive Pulmonary Disease (COPD). DMX-700 and DMX-700 were both identified using Dimerix’ proprietary assay, Receptor Heteromer Investigation Technology (Receptor-HIT), which is a scalable and globally applicable technology platform enabling the understanding of receptor interactions to rapidly screen and identify new drug opportunities.

For further information about Dimerix, please visit their website at www.dimerix.com

About DMX-200

DMX-200 is the adjunct therapy of a chemokine receptor (CCR2) antagonist administered to patients already receiving an angiotensin II type I receptor (AT1R) blocker - the standard of care treatment for hypertension and kidney disease. DMX-200 is protected by granted patents in various territories until 2032, with patent applications submitted globally that may extend patent protection to 2042, in addition to any exclusivity period that may apply in key territories. In 2020, Dimerix completed two Phase 2 studies: one in FSGS and one in diabetic kidney disease, following a successful Phase 2a trial in patients with a range of chronic kidney diseases in 2017. No significant adverse safety events were reported in any trial, and all studies resulted in encouraging data that could provide meaningful clinical outcomes for patients with kidney disease.

About FSGS

FSGS is a rare disease that attacks the kidney’s filtering units, where blood is cleaned (called the ‘glomeruli’), causing irreversible scarring. This leads to permanent kidney damage and eventual end-stage failure of the organ, requiring dialysis or transplantation. For those diagnosed with FSGS the prognosis is not good. The average time from a diagnosis of FSGS to the onset of complete kidney failure is only five years and it affects both adults and children as young as two years old.[i] For those who are fortunate enough to receive a kidney transplant, approximately 60% will get re-occurring FSGS in the transplanted kidney.[ii] At this time, there are no drugs specifically approved for FSGS anywhere in the world, so the treatment options and prognosis are limited.

FSGS is a billion-dollar plus market: the number of people with FSGS in the US alone is just over 80,000,² and worldwide about 220,000.[iii] The illness has a global compound annual growth rate of 8%, with over 5,400 new cases diagnosed in the US alone each year.[iv] Because there is no effective treatment, Dimerix has received Orphan Drug Designation for DMX 200 in both the US and Europe for FSGS. 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 a fast-tracked regulatory pathway to approval. Dimerix reported positive Phase 2a data in FSGS patients in July 2020.

[i] Guruswamy Sangameswaran KD, Baradhi KM. (2021) Focal Segmental Glomerulosclerosis), online: https://www.ncbi.nlm.nih.gov/b...

[ii] Front. Immunol., (July 2019) | https://doi.org/10.3389/fimmu....

[iii] Delve Insight Market Research Report (2022): Focal segmental glomerulosclerosis (FSGS) – Market Insight, Epidemiology and market forecast – 2032; https://www.delveinsight.com/r...;

[iv] Nephcure Kidney International (2020); Focal Segmental Glomerulosclerosis, online https://nephcure.org/livingwit...;