Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Rodman & Renshaw Healthcare Conference 2009
11 slides from Clinuvel Pharmaceuticals's conference presentation, Sep 11, 2009
Slide 1: Australia's Medicinal Photoprotection – Afamelanotide First-In-Class
Australia’s Medicinal Photoprotection Afamelanotide – First-In-Class For personal use only Clinuvel Pharmaceuticals Ltd Dr Philippe Wolgen, CEO ASX: CUV Thursday, 10th September 2009 XETRA-DAX: UR9 Rodman & Renshaw Healthcare Conference, New York ADR: CLVLY Australia’s medicinal photoprotective drug
Slide 2: Safe harbor statement
Safe harbor statement Clinuvel is an Australian biopharmaceutical company focused on developing its leading drug candidate, afamelanotide, for a range of UV- related skin disorders For personal use only resulting from exposure of the skin to harmful UV radiation. Pharmaceutical research and developm
Slide 3: Financials
Financials • Shares on issue 303,148,665 c/s • Fully diluted basis 320M c/s For personal use only • Market cap US$78m* • OPEX (Dec ’06-Jun ’09) <US$0.79m*/month • Reserves (Jun 30 ’09) US$30.6m* • Projected gross expenditures (Dec 31 ’10) US$24.2m* Clinuvel quarterly spend rate 2006-projected 2010 A
Slide 4: Afamelanotide: a world's first
Afamelanotide: a world’s first • First priority orphan diseases: For personal use only – porphyria (EPP: absolute light intolerance) – solar urticaria (SU: acute immune response to light/UV) • Registration strategy in 4 markets: EMEA, TGA, Swissmedic, FDA • Phase III completion Q4/09 (CUV017) In afa
Slide 5: Clinuvel's concept of biomimicry
Clinuvel’s concept of biomimicry Afamelanotide simulates the biological pigmentary response of the skin For personal use only Biological melanogenesis Activated melanogenesis Afamelanotide α-MSH α-MSH Melanin activation Melanin activation 3 1 2 4 Photoprotection DNA damage Increased Photoprotection
Slide 6: Afamelanotide 16mg implant
Afamelanotide 16mg implant For personal use only • Controlled release formulation • Proprietary technology Afamelanotide delivered by a novel implant technology, proprietary to Clinuvel. Developed over 10 years. 6
Slide 7: Pharmacodynamics
Pharmacodynamics Melanin Density Increase (MDI %) For personal use only Normalised melanin density 160 Skin types I-II (normally burns, no pigmentary response) Skin types III-IV (adequate pigmentary response) 150 140 130 120 110 100 0 12 30 40 60 Time (days) • Drug released over 10 days • Melanin de
Slide 8: Afamelanotide: EPP and SU priorities
Afamelanotide: EPP and SU priorities For personal use only References: Dunn, R et al (2009). “Afamelanotide, an α-melanocyte stimulating hormone (MSH) agonist reduces phototoxicity in Erythropoietic Protoporphyria (EPP), as tested under laboratory conditions.” Australasian Journal of Dermatology. 50
Slide 9: Commercialization of afamelanotide
Commercialization of afamelanotide Focus Orphan Diseases: SU & EPP Clinical program Commercial and regulatory targets For personal use only Q3 ‘09 Preliminary results Phase III EPP – EU, AUS (CUV017) Launch branding afamelanotide Scale up manufacturing afamelanotide Trial completion Phase III EPP –
Slide 10: Registration strategy afamelanotide
Registration strategy afamelanotide Patients to date Proof of concept trials Additional safety trials Liquid 1,700 doses in 137 patients Pharmacodynamics I p = 0.008 Phase II PLE I Implant 450 doses in 324 patients 81 patients MD: p < 0.01 18 patients MD: p < 0.05 Currently 210 patients on trial (~6
Slide 11: Summary
Summary • First-in-class, afamelanotide • Strong cash reserves For personal use only • Proprietary technology • Phase III porphyria (EPP) complete Q4/09 • MAA: EMEA first Photoprotection in orphan diseases 11 11
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