Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Investor Presentation (June 2011)
31 slides from Clinuvel Pharmaceuticals's investor presentation, Jun 9, 2011
Slide 1: Clinuvel Pharmaceuticals investor update
For personal use only Clinuvel Pharmaceu/cals is an Australian biopharmaceu/cal company in late stage development. The company is listed on the Australian Securi/es Exchange (CUV) with a secondary lis/ng on the German XETRA (UR9) and a level 1 ADR (CLVLY). 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 presenta/on and that may differ from the actual development by Clinuvel. 2
Slide 3: For personal use only
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Slide 4: 2010 overview and focus on SCENESSE
For personal use only In 2010 Clinuvel focused its opera/ons in Switzerland, reflec/ng its policy of filing its lead drug in Europe in 2011. Staff are maintained for clinical trials and support in Melbourne and New York. The company’s lead focus is SCENESSE® (afamelano/de), a first-‐in-‐class drug for
Slide 5: Funding and burn rate
For personal use only Clinuvel raised sufficient funds in 2006-‐07 to fund its SCENESSE® program to market for the first indica/on. The company’s burn (spend) rate has been consistent since 2007. The registry remains steady. 5
Slide 6: Lead technology and clinical application
Sse only — Lead technology and clinical application For personal
Slide 7: Clinuvel's technology
For personal use only Clinuvel’s technology is unique. Alpha-‐MSH is a naturally occurring hormone which ac/vates pigment to protect skin from ultraviolet and light damage. Afamelano/de, the ac/ve ingredient in SCENESSE®, is an analogue of alpha-‐MSH which mimics the biological ‘tanning response’
Slide 8: Melanogenesis
For personal use only Melanogenesis is the ac/va/on of melanin in skin, caused when alpha-‐MSH s/mulates melanocytes. By ac/va/ng pigment in skin, afamelano/de mimics a biological process and protects skin from ultraviolet and visible light. 8
Slide 9: Pandermal effect of SCENESSE
For personal use only SCENESSE® has a ‘pandermal’ (en/re skin) effect – administered in a single loca/on, the drug ac/vates pigment in skin across the body. Here you can see the pigmentary response of a pa/ent prior to and at the mid-‐point of a dosing cycle of SCENESSE®. 9
Slide 10: EPP indication
For personal use only EPP is a severe, rare metabolic disorder which causes absolute intolerance to light, par/cularly visible or ‘blue’ light. There are no effec/ve therapies for EPP which is a lifelong disorder. Light intolerance forces pa/ents to avoid sunlight and has a significant impact upon pa/
Slide 11: Vitiligo and INSPIRE program
For personal use only Vi/ligo is a pigmentary disorder causing the loss of melanocyte func/on in skin. This disease has a severe impact upon pa/ent quality of life (Talsania, Lamb & Bewley, 2010 & Linthorst Homan et al, 2009) and no effec/ve treatments have been iden/fied to date. No drugs have been a
Slide 12: Trials in other dermatoses
For personal use only Trials in two other groups of pa/ents with dermatoses are underway with results expected this year. 12
Slide 13: Path to market - SCENESSE
AjUO 8S —» Path to market - SCENESSE® jeuosied 1oJ 13
Slide 14: Regulatory process
For personal use only The regulatory process is not well understood outside of the industry but starts well before dossier submission in ongoing discussions. Regulatory agencies (EMA/FDA) work within set laws to evaluate the safety and efficacy of a drug for a set pa/ent popula/on. This process involv
Slide 15: EPP clinical program
For personal use only Clinuvel’s clinical program for EPP to date has shown the drug is effec/ve in reducing the number and severity of phototoxic reac/ons in EPP. Anecdotally the drug has been shown to have a posi/ve impact on pa/ent quality of life, allowing greater exposure of skin to light, par/c
Slide 16: Safety evaluation
For personal use only The safety evalua/on of the drug will involve a review of all safety data generated to date. Across all of Clinuvel’s clinical program to date, afamelano/de (SCENESSE®, controlled release implant) has maintained a good safety profile. 16
Slide 17: Milestones
For personal use only Milestones are subject to clinical results. 17
Slide 18: European regulatory path
For personal use only In Europe, Clinuvel has had posi/ve discussions with the central agency (EMA). Orphan drug designa/on waives applica/on fees and en/tles the company to assistance throughout the applica/on procedure. Filing date subject to posi/ve results CUV029 and CUV030. Regulatory ac/vi/es
Slide 19: US FDA path
For personal use only Clinuvel is currently analysing data from its Phase II US EPP study (CUV030) amer which it will discuss the ongoing EPP program with the FDA. 19
Slide 20: Italian reimbursement
For personal use only In 2010 SCENESSE® was added to the list of reimbursable drugs under the Italian law 648/96. This allows the drug to be prescribed to Italian EPP pa/ents and the cost be reimbursed to Clinuvel under the Italian healthcare system. Agreed pharmacoeconomic benefit of €32,250 worth o
Slide 21: SCENESSE commercialisation
For personal use only SCENESSE® commercialisation Clinuvel 21
Slide 22: Clinical indication strategy
For personal use only Clinuvel has a clear strategy based around two clinical indica/ons for which there are no effec/ve medical therapies to date. Addi/onal clinical indica/ons (OTR pa/ents and PLE) will be evaluated based on pending clinical results. 22
Slide 23: Global EPP patient populations
For personal use only Clinuvel has invested in iden/fying global EPP pa/ent popula/ons. 23
Slide 24: Distribution options
For personal use only Two distribu/on op/ons exist. Due to Clinuvel’s exper/se in the space, self distribu/on for ‘orphan’ markets is feasible. For larger markets opportuni/es with other par/es are being evaluated. 24
Slide 25: Quality of life positioning
For personal use only The drug’s value has been posi/oned based on its impact on Quality of Life (QoL). A survey by an independent agency in a number of countries and posi/oned EPP’s compara/ve severity between chronic pain (longer than 3 months) and haemophilia, a life long disease. EPP poses a sig
Slide 26: Pharmacoeconomic benefit
For personal use only The pharmocoeconomic benefit of SCENESSE® has been independently evaluated. A number of factors aoribute to the pharmacoeconomic benefit, including: •Impact on quality of life; •Unmet medical need; •Lack of available therapy; •Pediatric pa/ent popula/on and disease impact on chil
Slide 27: Pipeline expansion
AjUO 8S — Pipeline expansion jeuosied 1oJ 27
Slide 28: Expanding the melanocortin pipeline
For personal use only As the SCENESSE® program nears its first regulatory filing, Clinuvel is looking to exploit its unique understanding of novel melanocor/n drugs. We have seen conceptual support in the clinic and from regulators for a pandermal photoprotec/ve, a novel product. The company has expan
Slide 29: CUV9900
For personal use only CUV9900 is a second genera/on melanocor/n drug in development. Preclinical and formulatory work is now underway with this product. Intellectual property on CUV9900 is strong. Results yet to be published. * Image: uploaded to Flickr.com by BrandontheMandon 29
Slide 30: Evaluating further opportunities
For personal use only Clinuvel is evalua/ng further opportuni/es to expand its business. Need to balance the company’s agenda between expansion and our primary focus, SCENESSE®. 30
Slide 31: Summary
For personal use only The company has sufficient funds to meet its commercialisa/on goals for EPP and to evaluate its exis/ng program. Clinuvel is approaching its first filing for SCENESSE® in the orphan indica/on EPP, having established and consolidated the concept of medicinal photoprotec/on in pa/ent
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