Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Shareholder Meeting (November 2007)
25 slides from Clinuvel Pharmaceuticals's shareholder meeting presentation, Nov 16, 2007
Slide 1: Annual General Meeting 16 November 2007
For personal use only Clinuvel Pharmaceuticals Ltd ASX:CUV; XETRA-DAX:UR9 Annual General Meeting 16th November 2007 Melbourne, Australia Philippe Wolgen, CEO Roger Aston, Executive Chairman
Slide 2: For personal use only
For personal use only
Slide 3: Safe harbor statement
Safe harbor statement For personal use only Clinuvel is an Australian biopharmaceutical company focused on developing its leading drug candidate, CUV1647, for a range of UV- related skin disorders resulting from exposure of the skin to harmful UV radiation. Pharmaceutical research and development in
Slide 4: May 2007 research on melanin and ionizing radiation
23 May 2007: ”Ionizing Radiation Changes the Electronic For personal use only Properties of Melanin and Enhances the Growth of Melanized Fungi Ekaterina Dadachova1,2*, Ruth A. Bryan1, Xianchun Huang1, Tiffany Moadel1, RADIATION EATERS: New research may show that fungi with melanin—the protective pig
Slide 5: Melanin, photo protection
Melanin, photo protection: biological conductor light For personal use only dermal homeostasis absorbs 200 – 700 nm light 1,050,000 ref. skin cancer 722,000 diseases 579,000
Slide 6: CUV months performance (2005-2007)
For personal use only CUV 24 months performance (2005 -2007)
Slide 7: Value Drivers 2006
Value Drivers 2006 For personal use only • √ Phase II photo protection trial Sydney - p< 0.015 sunburn and p<0.0001 MD increase • √ Phase II sun allergy (PLE) - p< 0.01 systemic steroid use • √ Phase II porphyria (EPP) - p< 0.007 • √ Building IP • √ Funding A$41M
Slide 8: Value Drivers 2007
Value Drivers 2007 For personal use only • √ Funding A$26M • √ Phase III approval MHRA UK/EU in sun poisoning (PLE) • √ 5th indication CUV1647 validated + filed patent application • √ Start Phase III sun poisoning (PLE) • √ Start Phase III porphyria (EPP) • √ Start Phase II skin cancer organ transpl
Slide 9: Clinuvel share price chart
Clinuvel tastPrice Herron 03/30/07 L@wypn 01/25/06 409 oo000 >to ~4i BOK oOn~nn @) W =) wim obra” A = \ A J f Ws / rr Ay ou Sion closed) S412 Ss TT is r AwA ne {“ f: aol 4 ntl Ne f pe bepre pot PFA 9. -- SI, vf - -* Naf Ay SA nr f KL). f. Utne Y 5 se osiemssd Vd ie * Va Layer itgnc afte O- Yolume 0.
Slide 10: Clinuvel Planning 2008
Clinuvel Planning 2008 16 Nov’ 07 1 Jan’ 08 Mar’ 08 July’ 08 1 Oct’ 08 1 Dec ‘08 1 Jan’ 09 For personal use only AGM - Start SU PhII EU AGM - Completion online platform CUV - WHO Generic name CUV1647 - Brand name CUV1647 - Start EPP PhII US - Start PDT PhII US - Start SCC Ph II RMH (Melbourne) - Fil
Slide 11: Regulatory Pathway CUV1647
Regulatory Pathway CUV1647 For personal use only • EU submission – filing by 2009 • Swiss submission – filing by 2009 • Australian submission – filing by 2009 • US IND Q1 2008
Slide 12: Filing for Regulatory Approval 2009
For personal use only Filing for Regulatory Approval 2009
Slide 13: Filing for Regulatory Approval 2009
For personal use only Filing for Regulatory Approval 2009 Recruitment/Retention
Slide 14: Filing for Regulatory Approval 2009: dossier compilation
For personal use only Compilation of dossier (hundreds of volumes) Filing for Regulatory Approval 2009 Recruitment/Retention
Slide 15: Filing for Regulatory Approval 2009: agency evaluations
For personal use only Agency evaluations Compilation of dossier (hundreds of volumes) Filing for Regulatory Approval 2009 Recruitment/Retention
Slide 16: Phase I, II and III: de-risking business in patients
Phase I, II and III: de-risking business in 950 patients Proof Principle For personal use only Questioning Agency evaluations Compilation of dossier Clinical Strategy (hundreds of volumes) Approach Department heads Pre Study assessments (12-18 months) ICHGCP Audit Identify Centres Identify endpoints
Slide 17: Route to Markets CUV1647
Route to Markets CUV1647 For personal use only • Final product, 1st generation, first-in-class CUV1647 – Manufacturing – Pricing product • Regulatory pathway determined • Prepare company for commercial phase – Medical benefit in first underserved population of patients – Distribution, sales – Market
Slide 18: Communication Clinuvel: Open Forum
For personal use only Communication Clinuvel Open Forum CUV Building a captive audience 2001 – 2007: • personalized information, 5 stake holders • interactive • thought leadership
Slide 19: Core expertise Clinuvel
For personal use only Core expertise Clinuvel • Skin & skin diseases • UV and light, biophysics • Melanin, pigmentation
Slide 20: Clinuvel.com monthly webstats
Clinuvel.com monthly webstats Nov 2006 – Oct 2007 For personal use only 80,000 70,000 60,000 50,000 40,000 30,000 20,000 10,000 0 Nov-06 Jun-07 Jul-07 Jan-07 May-07 Aug-07 Feb-07 Dec-06 Mar-07 Apr-07 Oct-07 Sep-07
Slide 21: Clinuvel investor website
Clinuvel Lorem ipsum dolor sit amet, consec tetuer adipiscing elit. Vestibulurn imperdiet viverra magna. Morbi accumsan arcu nec erat. Nullam at tellus eu nunc tempor last trious mon condimentum. Fusce omare tempor mauris. Integer purus eros, pretium eget, consequat vitae, rutrum vitae, libero. Fusc
Slide 22: Investor website: Corporate Overview
Clinuvel Investor website Home = Corporate Corporate Corporate Overview Clinuvel Pharmaceuticals Limited is a Melbourne based biopharmaceutical company focused on developing its leading drug candidate CUV1B47 Busi Products Clinical Applicati Currently in Phase Il and Phase Ill clinical trials, CUV16
Slide 23: Clinical sites and success factors for CUV1647
25 sites, Clinical Coordinator (6) visits patients For personal use only Melbourne, Stockholm, Paris, Zürich, Düsseldorf, Cardiff Success CUV1647: • SAFETY, EFFICACY • Retaining patients in trial • Registration • Awareness
Slide 24: Conclusions
Conclusions For personal use only • Safety CUV1647 in >300 patients since 1995 • Efficacy in sun poisoning (PLE) and porphyria (EPP) Phase 3 started Skin cancer in organ transplant patients, high at risk (AK/SCC) • Increase pigmentation (melanin) offers photo protection in fair-skinned patients • Ai
Slide 25: Thank you
For personal use only Thank you team Clinuvel……unbelievable performance to date….
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