Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Non-Deal Roadshow (May 2009)
17 slides from Clinuvel Pharmaceuticals's roadshow presentation, May 18, 2009
Slide 1: May 2009 European Roadshow
For personal use only May 2009 European Roadshow Dr D Wright, VP Scientific Affairs ASX: CUV Mr LJ Wood, Director Xetra: UR9 Dr Ph Wolgen, CEO ADR: CLVLY
Slide 2: Safe harbor statement
Safe harbor statement For personal use only Clinuvel is an Australian biopharmaceutical company focused on developing its leading drug candidate, afamelanotide, for a range of UV- related skin disorders resulting from exposure of the skin to harmful UV radiation. Pharmaceutical research and developm
Slide 3: Clinuvel's proprietary drug: afamelanotide
Clinuvel’s proprietary drug: afamelanotide For personal use only • Medicinal photoprotection • Activates melanin (pigment) systemically • Protects skin from UV and visible light • Acute clinical need
Slide 4: Biological melanogenesis
Biological melanogenesis For personal use only 3 α-MSH Melanin activation 4 Photoprotection DNA damage 2 UV/visible light 1 impacts skin
Slide 5: Enhanced melanogenesis
Enhanced melanogenesis For personal use only Afamelanotide 1 α-MSH Melanin activation 2 Increased Photoprotection = Reduced DNA damage 4 UV/visible light 3 impacts skin
Slide 6: Drug delivery: pharmacokinetics vs pharmacodynamics
Drug delivery Pharmacokinetics vs pharmacodynamics For personal use only Name Dose Release Plasma level Duration Secondary (peak) endocrine effects Testosterone 100 mg pulsatile 3 - 10 ng/ml 4 – 5 months Estrogen 25 - 50 mg sustained 30 pg/ml 4 - 8 months testosterone 0.25ng/ml LHRH 3.6 mg/10.8 mg c
Slide 7: Afamelanotide implant
Afamelanotide implant For personal use only • Optimal release of afamelanotide • Uniform distribution of drug throughout the implant core
Slide 8: Drug level and melanin density
Drug level and melanin density For personal use only ng/ml Melanin density Drug levels in plasma 0 10 20 30 40 50 60 Days • Drug released over 7 to 10 days • Melanin density elevated for 60 days
Slide 9: Afamelanotide – indications
Afamelanotide – 5 indications For personal use only Erythropoietic Protoporphyria (EPP) Absolute sun/UV intolerance Photodynamic Therapy (PDT) Phototoxicity following cancer treatment Solar Urticaria (SU) Acute immune reaction to sun/UV Actinic Keratosis (AK) / Squamous Cell Carcinoma (SCC) Skin can
Slide 10: Orphan Drug Strategy
Orphan Drug Strategy For personal use only • Incidence: < 200,000 (US), < 5 in 10,000 (EU) • Severe disorders: porphyrias (EPP/CEP) • No current effective therapy • 2008 Orphan Drug Designation: - EMEA / SwissMedic / FDA / TGA (pending) Benefits Advice / Reduced fees / Route to market
Slide 11: Erythropoietic Protoporphyria (EPP)
Erythropoietic Protoporphyria (EPP) For personal use only • Genetic disease: deficiency of ferrochelatase • Absolute sun/UV intolerance: phototoxicity • Childhood: misdiagnosis, misery (and for parents) • Adult patients: adaptive behaviour (sun avoidance) • Clinical protocols: 1 or 2 endpoints
Slide 12: Clinical data to registration
Clinical data to registration Liquid 1,700 doses in 137 patients Implant 450 doses in 324 patients For personal use only Currently 190 patients on trial Pharmacodynamics I p = 0.008 81 patients MD: p < 0.01 Phase II PLE I 18 patients MD: p < 0.05 Pharmacodynamics II p < 0.0001 45 patients MD: p < 0.
Slide 13: Regulatory evaluation
Regulatory evaluation For personal use only Mar 2008 Apr 2008 Jun 2008 Jul 2008 Jan 2009 ODD EMEA ODD WHO generic ODD FDA IND FDA SwissMedic name Risk Benefit Safety established in Therapeutic benefit in large patient serious disease (EPP) populations No safety concerns identified
Slide 14: Route to market
Route to market Probability PDT SU EPP For personal use only OTR AK/SCC Greatest clinical need PLE Value Patient population Condition Treating Physicians Population EPP Hematologists/Dermatologists >5000 OTR AK/SCC Transplant Surgeons/Dermatologists >10m PDT Oncologists/Gastroenterologists >5000 SU
Slide 15: Financials
Financials For personal use only • MKTCAP A$93.9M • A$39.4M reserves • A$1.2M per month cash spend • 15 yr R&D - A$55M to date • A$38M projected to marketing authorisation • 303M shares • 64% held by top 50 shareholders $1.50 $1.25 Volume: 309,299/day (last 6 months average) ASX closing share price
Slide 16: Summary
Summary For personal use only • Strong cash reserves • Proprietary technology • ODD status / IND granted • Defined path to market • Phase III EPP results Q4/09 • Registration application imminent Medicinal photoprotection
Slide 17: For personal use only
"...where no one has gone before..."
Clinuvel Pharmaceuticals — Non-Deal Roadshow (May 2009) on 6ix