Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Investor Presentation (April 2009)
18 slides from Clinuvel Pharmaceuticals's investor presentation, Apr 24, 2009
Slide 1: Investor presentation, Melbourne 23 April 2009
For personal use only Melbourne, 23rd April 2009, 4:30pm Dr D Wright, VP Scientific Affairs Dr H Agersborg, CSO Dr Ph Wolgen, CEO
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 Pharmaceuticals Ltd
Clinuvel Pharmaceuticals Ltd ASX: CUV For personal use only Xetra: UR9 ADR: CLVLY • Afamelanotide: Medicinal photoprotection First-in-class drug • Completion Phase III 2009 + MAA • foster Australian value investment 55:45%
Slide 4: For personal use only
00:00:00 AjuoO esn feuosied JOS
Slide 5: For personal use only
16:05:98 Ajuo esn feuosied JOS
Slide 6: Chemistry, Manufacturing, Controls
Chemistry, Manufacturing, Controls For personal use only
Slide 7: Implant Release Profiles
Implant Release Profiles For personal use only 20 18 16 Afamelanotide Released (mg) 14 12 10 8 10 mg 6 16 mg 20 mg 4 2 0 0 1 2 3 4 5 6 7 Days
Slide 8: Afamelanotide increases melanin density
Afamelanotide increases melanin density For personal use only Photoprotection to fair skin (Fitzpatrick type 1 and 2) Drug released over 7 to 10 days Melanin increased for 60 days Am J Epidemiol, 2002; J Inv Dermatol, 2006; NEJM, 2009
Slide 9: EPP - Photoprotection
EPP - Photoprotection For personal use only • Genetic disease: deficiency of ferrochelatase • Absolute sun intolerance: phototoxicity • Childhood: misdiagnosis, misery (and for parents) • Adult patients: adaptive behaviour (sun avoidance) • Clinical protocols: 1 or 2 endpoints
Slide 10: Orphan Disease(s) = Rare Disease(s)
Orphan Disease(s) = Rare Disease(s) For personal use only • Incidence: < 200,000 (US), < 5 in 10,000 (EU) • Severe disorders: porphyrias • Lack of current effective therapy: photoprotection • 2008 Orphan Drug Designation: - EMEA - SwissMedic - FDA - TGA (pending)
Slide 11: CUV Integrated Clinical Program
CUV Integrated Clinical Program e.g. EPP (porphyria) For personal use only • 5,000 registered patients • 11 countries • Intense program management – online/offline • Networks – patients and physicians
Slide 12: Clinical Data
Clinical Data Liquid 1,700 doses in 137 subjects Implant 450 doses in 324 subjects For personal use only Currently 190 patients Study # 008 p < 0.0001 Phase II 2005 n = 45 MD: p < 0.03 Phase I Studies # 006-007-009 2006 Confirmatory PK, final dose and formulation n = 28 MD: p < 0.05 Study #012 p = 0
Slide 13: Quantitative Analysis Clinuvel
Quantitative Analysis Clinuvel —eT/C —™Reg —*— Bus —<— Acid Score 2007 Years Total score: 40/66 For personal use only
Slide 14: Value proposition
Value proposition Probability PDT EPP SU For personal use only OTR AK/SCC PLE Focus on greatest clinical need serving as a proof of concept Value Patient population Condition Treating Physicians Population EPP Hematologists/Dermatologists >5000 AK/SCC Transplant Surgeons/Dermatologists >10m PDT Onco
Slide 15: Case study: Genzyme orphan drugs
Case study: Genzyme orphan drugs For personal use only Drug Disease Annual cost Incidence Ph III trial per patient size Cerezyme Gaucher disease >$300,000 5000 worldwide 40 Fabrazyme Fabry disease ~$180,000 5000 worldwide 56 0.25 per 10,000 Myozyme Pompe disease $200,000- ~1000 worldwide 18 300,000
Slide 16: Financials
Financials For personal use only • MCAP A$84M (FD=A$108M) • A$39.48M reserves, A$1.2M burn rate (A$1.7M Q3’09) • 15 yr development cycle - A$55M to date, A$93M • 303M o/s (F/D 326M) • 64% in 50 different holdings
Slide 17: Summary
Summary For personal use only • Clinuvel is funded to market A$39.4M • Afamelanotide - first-in-class drug • Intense risk management • Corporate development ongoing
Slide 18: For personal use only
For personal use only “…where no one has gone before…”
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