Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Investor Presentation (March 2010)
14 slides from Clinuvel Pharmaceuticals's investor presentation, Mar 30, 2010
Slide 1: Approaching end-stage development of the world's first photoprotective
For personal use only Clinuvel is approaching the end-stage of development of a most exciting drug, the world’s first photoprotective. No other drug provides dermal photoprotection, mimicking the physiological response by the skin, following light and UV exposure. 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 presentation and that may differ from the actual development by Clinuvel. 2
Slide 3: FDA allows Phase II trials in EPP under current IND
For personal use only √ √ √ √ Fifty months ago a new management team was installed with the objective to investigate the pathways to develop afamelanotide as first medicinal photoprotective. The management started from an existing base where analogues of alpha-MSH had been extensively tested. A clin
Slide 4: Cash reserves and burn rate
For personal use only Cash reserves are sufficient to meet our regulatory objectives. Burn rate is a monthly cash spend, has been kept consistent over the past 2.5 years. Stability of shareregister is clear. 4
Slide 5: Conservative approach to expenditure
For personal use only The company has adopted a conservative approach to date, aiming to minimise expenditure and focus on its clinical program and drug product development. 5
Slide 6: Path to market for afamelanotide
For personal use only Clinuvel has identified a clear path to market for afamelanotide and is pursuing a program to arrive at an application for marketing authorisation (MAA) first in Europe. The last 18 months Clinuvel has prepared for the commercialisation of afamelanotide. Looking at the current
Slide 7: Afamelanotide implant design
For personal use only √ √ √ √ Implant chosen over liquid injection because of superior pharmacodynamic effect. Polymer is not novel and was chosen because it had been used in pharmaceutical applications already registered. Drug release from implant core optimised to maximise effects on melanin level
Slide 8: Orphan drug strategy and clinical program
For personal use only Orphan drug strategy to develop afamelanotide for patients who have not yet received adequate medicinal therapy. The middle column illustrates Clinuvel’s main clinical program in porphyria (EPP) for which the company anticipates the first registration filing. The right column s
Slide 9: Target patients most affected by UV and light
For personal use only Clinuvel has focused its clinical program on treating patients who are most severely affected by UV and light. Image on the bottom left shows an organ transplant recipient who has had multiple surgeries to his ear to remove actinic damage (lesions). Organ transplant recipients
Slide 10: Clinical and regulatory timeline
For personal use only FDA approval start EPP (US) CUV030 [6 months] US confirmatory PK study results CUV028 EPP Ph III confirmatory trial start (EU) CUV029 [6 months] PLE Ph III trial starts (EU) CUV032 [4 months] EPP Ph III final results (EU/AUS) CUV017 EMA-FDA approval Brand Name EMA filing regist
Slide 11: EPP patient populations globally
For personal use only Clinuvel has identified EPP patient populations globally in preparation for commercialisation. Example of Clinuvel’s global planning is given with the Swedish known-patient distribution. 11
Slide 12: Analyst views on commercial potential
For personal use only Analysts recognize the commercial potential of afamelanotide in EPP, but also map out future revenues upon further development of the product in general light and UV related disorders. 12
Slide 13: Preparing for commercialization
For personal use only The CUV team is preparing for commercialization of the drug product, whereby 2 options are being evaluated. SAFETY in drug development is essential. EPP is the most severe indication: patients have no effective therapy to date. Regulatory interaction is a guide along the way to
Slide 14: Closing summary
For personal use only CUV is approaching the end-stage of development of a most exciting drug, the world’s first photoprotective No other drug provides dermal photoprotection mimicking the physiological response by the skin, following light and UV exposure 14
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