Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Shareholder Meeting (November 2010)
23 slides from Clinuvel Pharmaceuticals's shareholder meeting presentation, Nov 10, 2010
Slide 1: Turning a scientific concept into commercial reality
For personal use only The most challenging objective in the pharmaceutical industry is turning an unproven idea, a scientific concept, into a commercial reality: Achieved by the Clinuvel team this year. 1
Slide 2: Forward-looking statements
For personal use only This mandatory statement aims to protect from any forward-looking statements that may be inferred from the presentation and that may differ from the actual development by Clinuvel. 2
Slide 3: Three aspects of Clinuvel's business
For personal use only In this presentation, the emphasis will be on three aspects of Clinuvel’s business: • Definition of its assets • Route to market • The next steps to realise shareholder value 3
Slide 4: Clinuvel's assets
For personal use only Clinuvel’s assets are much broader defined than the innovative technology: •The chemistry has been optimised and subject to novel synthesis •The technology has been refined to a patented and proprietary controlled release formulation: •subcutaneously injectable SCENESSE® (afame
Slide 5: Foundation of development: safety, demand, support
For personal use only The foundation of Clinuvel’s unique development hinges on three factors: Safety Demand Support 5
Slide 6: Financial discipline and shareholder registry
For personal use only A strict financial discipline marks the company’s progress over the years. Expenditures are curbed, and much of the work is performed internally with minimal outsourcing of services. Knowledge retention is key to success, and is more cost efficient. The registry is well distrib
Slide 7: Regulatory landscape for novel products
For personal use only In the regulatory landscape where significant decisions are arrived at daily, there are still very few novel products which are achieving successful reviews. Clinuvel’s challenge will be to belong to a select group of companies developing a NME to market. The company is well po
Slide 8: How is the company unfolding its route to market?
For personal use only How is the company unfolding its route to market? 8
Slide 9: Development progress and milestones of SCENESSE
For personal use only A brief overview of the development progress to date, critical milestones in the pharmaceutical development of SCENESSE®. 9
Slide 10: EPP: preventative therapy and analytical matrix
For personal use only In understanding the ‘analytical matrix’, EPP was not only the most likely photodermatosis to respond to SCENESSE®, but it also fitted the criteria: Severity Lack of standard of care Positive regulatory reviews In EPP, Clinuvel addresses a preventative therapy 10
Slide 11: Vitiligo: symptomatic treatment
For personal use only In vitiligo, Clinuvel addresses symptomatic treatment. Severity Lack of standard of care Positive regulatory feedback. A non-orphan drug indication with a sizeable market. 11
Slide 12: Reference to the 2010 Annual Report
For personal use only The reader is referred to the 2010 Annual Report 12
Slide 13: Mapping of EPP patient populations
For personal use only The mapping of EPP populations requires much of CUV’s effort, enabling the company to identify the patients who seek treatment in various continents. Continuous efforts go into understanding the willingness of patients to seek treatment, or whether they have resigned to not rec
Slide 14: Regulatory timeline and European filing
For personal use only This timeline is subject to the regulatory approval process. The company intends to file for first registration in Europe in 2011, pending ongoing safety and clinical efficacy in EPP. 14
Slide 15: Clinuvel is focused on creating shareholder wealth
For personal use only Clinuvel is focused on creating shareholder wealth. 15
Slide 16: Positioning of treatment and pharmacoeconomic modelling
For personal use only Positioning of treatment early on is key to the decisions made by the Clinuvel management. Revealing is that various studies indicate that erythropoietic protoporphyria (EPP) is perceived more severe than solar urticaria (SU) by governmental bodies, payors and medical consultan
Slide 17: Pathway to first reimbursement of SCENESSE
For personal use only To explain the lengthy but complex pathway which led to the first reimbursement of SCENESSE®, a flow diagram is presented illustrating the sequence of events which led to the historical breakthrough for Clinuvel. Most importantly, the European Pricing Survey proved to be accura
Slide 18: Italian reimbursement under law 648/96
For personal use only The survey’s outcome indicated at the end of 2009 that SCENESSE® would be reimbursable for EPP. A hypothetical case turned into reality with the regulatory clearance to include the drug as a preventative therapy for Italian patients. Italy took European leadership and included
Slide 19: Pandermal photoprotection in EPP
For personal use only SCENESSE® provides ‘pandermal’ photoprotection in EPP. What have we learned over the years? 19
Slide 20: Product expansion program
For personal use only Clinuvel is revealing its product expansion program in ‘systemic’ (its current clinical program) and loco regional photoprotection; a rationale is provided. 20
Slide 21: Loco regional photoprotection and CUV9900
For personal use only The proof of concept of developing a drug to provide pandermal photoprotection has been successful to date. The medicinal benefit is being confirmed in Clinuvel’s ongoing trials, e.g. in EPP, SU and PLE. Clinuvel’s further expansion of its program is to provide loco regional ph
Slide 22: Summary
Summary Proof of principle of medicinal photoprotection established Product expansion in photoprotection Reimbursement accepted, 1St revenues EPP Evaluation of collaborations/partnerships ongoing 22
Slide 23: Clinuvel Pharmaceuticals AGM 2010
Clinuvel Pharmaceuticals Ltd SCENESSE® world’s first medicinal photoprotective drug AGM 2010 10 November Philippe Wo 23
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