Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Corporate Update (March 2012)
15 slides from Clinuvel Pharmaceuticals's corporate update, Mar 21, 2012
Slide 1: Clinuvel Pharmaceuticals: Entering Commercialisation
For personal use only Clinuvel Pharmaceuticals Entering Commercialisation March 2012 Corporate Update Stan McLiesh, Chairman Philippe Wolgen, CEO Darren Keamy, CFO ASX: CUV XETRA-DAX: UR9 ADR: CLVLY
Slide 2: Safe harbor
Safe harbor 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 development involv
Slide 3: Company overview
Company overview • Global biopharmaceutical company focused on the development of drugs for the For personal use only treatment of a range of severe skin disorders • Primary focus is the development of SCENESSE, a proprietary drug with a range of applications (nonsegmental vitiligo, erythropoietic p
Slide 4: Directors and key management
Directors Mr Stan McLiesh, BEd For personal use only Non-Executive Chairman, >30 yrs pharma experience – commercialisation, M&A Mrs Brenda Shanahan, Mr Jack Wood, Mr Elie Ishag Non-Executive Directors, broad background in finance, healthcare, pharma deal making Dr Hank Agersborg, BSc, PhD Chief Scie
Slide 5: SCENESSE (afamelanotide)
SCENESSE® (afamelanotide) For personal use only • An analogue of the naturally occurring melanocortin alpha-MSH • Unique properties due to optimized chemistry • Systemic photoprotection, provides filter for light-UV • First-in-class drug (New Molecular Entity) • Patented injectable 16mg resorbable f
Slide 6: Development cycle & milestones '06-'12
Development cycle & milestones ‘06-‘12 For personal use only EU Ph II EPP results, approval for EU Ph III1 EPP trial FDA allows EPP Ph II FDA allows vitiligo Ph II Clinical & FDA allows IND Vitiligo program starts, US Ph II, EU Final SCENESSE® dose EU Ph III1 EPP regulatory selected starts, EU Ph II
Slide 7: 1st Clinical target: EPP
1st Clinical target: EPP Erythropoietic protoporphyria (EPP) – absolute light intolerance For personal use only Est. global incidence: up to 11,000 assessable patients (4,500 EU/6,500 US) • Rare (orphan) lifelong genetic disorder • No effective treatment/preventative – high unmet clinical need • SCE
Slide 8: Italian EPP program – distribution model
Italian EPP program – distribution model For personal use only • Italian law allows prescription of SCENESSE® to EPP patients, reimbursement for supply by Italian government • Agreed pharmacoeconomic benefit with national reimbursement agency - €32,250/patient/per annum • 12 month (2010-2011) sales
Slide 9: Transitioning from R&D to commercial sales
Transitioning from R&D to commercial sales For personal use only • 1st Marketing Authorisation Application for EPP filed with EMA Feb 2012, decision expected Q4 ’12 - Q1 ‘13 • EU reimbursement discussions underway • High level global physician and patient support • Solo distribution versus partnersh
Slide 10: 2nd Clinical target: vitiligo
2nd Clinical target: vitiligo Vitiligo – acquired depigmentation disorder For personal use only Est. global incidence: 45 million patients • Progressive, psychologically devastating disease • No effective treatment to date, high unmet clinical need (FDA) • SCENESSE® used as combination repigmentatio
Slide 11: Observations from vitiligo clinical programs
Observations from vitiligo clinical programs • Clinical observations presented at leading global dermatology For personal use only conferences (AAD/EADV) • Physicians encouraged at speed, depth of repigmentation following afamelanotide implant + NB-UVB treatment vs NB-UVB alone Day 0 - baseline Day
Slide 12: Preliminary Data on HFH Patients
Preliminary Data on 15 HFH Patients Average Time to Onset of First Repigmentation (From day 1 of NB-UVB treatment) For personal use only No. Weeks of NB-UVB until No. NB-UVB treatments until repigmentation repigmentation Afamelanotide/ NB-UVB 5.75 wks 12.25 tx (n=8) NB-UVB Only 6.7 wks 19.5 tx (n=7)
Slide 13: Prospective markets
Prospective markets India For personal use only • Estimated >10M vitiligo patients • National healthcare system • Vitiligo recognised as national healthcare priority • High level NB-UVB penetration USA - EPP EU - EPP • 6,500 EPP patients • 4,500 EPP patients USA - vitiligo • Up to 6M vitiligo patien
Slide 14: Additional Programs Pipeline
Additional Programs Pipeline Preclinical Phase II Phase III For personal use only Product: SCENESSE® (afamelanotide) Polymorphous light eruption (PLE), likened to sun poisoning – EU Product: SCENESSE® (afamelanotide) Actinic keratosis and squamous cell carcinoma in transplant patients, skin cancer i
Slide 15: Conclusions
Conclusions • Focussed and committed lean organisation based in 3 continents For personal use only • SCENESSE® on track for market registration in erythropoietic protoporphyria (EPP) – Orphan drug indication US and EU, no current therapy – Positive, statistically significant US Phase II and EU Phase
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