Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Shareholder Meeting (November 2011)
22 slides from Clinuvel Pharmaceuticals's shareholder meeting presentation, Nov 9, 2011
Slide 1: Company Announcement: CEO's AGM Presentation
Company Announcement CEO’s AGM Presentation Wednesday 9 November, 2011 For personal use only Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) has released the CEO’s presentation to the company’s Annual General Meeting of Shareholders, a copy of which is appended below. - End -
Slide 2: Annual General Meeting 2011: Quest for Value
A — TAS Clinuve CLINUVEL PHARMACEUTICALS ANNUAL GENERAL MEETING 2011 Quest for Value Melbourne 9 November S McLiesh, Chairman ASX: CUV Ph Wolgen, CEO XETRA-DAX: UR9 ADR1: CVLVY
Slide 3: Forewarning on speculative comments
For personal use only This statement serves as forewarning against comments that may be interpreted as speculative during presentation. 2
Slide 4: Value creation and the R&D model in the sector
For personal use only At a time when development pipelines are drying up there are fundamental questions being posed on our sector and the role of SME in the R&D process. Does value creation follow R&D efforts? • Classical R&D model under duress in large pharma houses • Cost of R&D of a NME is more
Slide 5: Board consolidation, cash burn and share register
For personal use only •The company has consolidated its Board in 2010-2011. •Monthly cash burn (spend) has been stable during this period. •Share register split 65% International : 35% Australian. 4
Slide 6: Two alpha-MSH analogue technologies in development
For personal use only Clinuvel has two key technologies in development, both of which are based on alpha- Melanocyte Stimulating Hormone analogues. Near term value for shareholders is expected from SCENESSE® (afamelanotide) on which today’s presentation will focus. CUV9900 is a complementary technol
Slide 7: SCENESSE indications from EPP to vitiligo
For personal use only Our current pipeline reflects a diversity of potential application for SCENESSE® with indications ranging in population from 10,000 (EPP) to 45 million (vitiligo). 6
Slide 8: Monitoring success against drug development benchmarks
For personal use only Since a change in management the company has routinely monitored its success against key drug development benchmarks for the company’s first development program. 7
Slide 9: Value creation and regulatory strategy
For personal use only Value creation is determined by safety and efficacy of New Molecular Entity (SCENESSE®), the regulatory strategy chosen and, significantly, whether a drug becomes first-line therapy versus second-line or add-on therapy. The regulatory outcome ultimately influences the positioni
Slide 10: The clinical-regulatory funnel
For personal use only This is the clinical – regulatory funnel we all have to go through, but typically the hurdles are taken in serial order. 9
Slide 11: Positioning and reimbursement ahead of approval
For personal use only At Clinuvel we started to address positioning and reimbursement ahead of any regulatory approval. All boxes are ticked, with three left on our list: • Filing EMA is in process; • FDA is reviewing our data and an End-of-Phase II meeting is being requested for discussing the EPP
Slide 12: Italian sales model of SCENESSE
For personal use only The Italian sales model of SCENESSE® provides insight on patient, physician behaviour, repeat demand for the drug, penetration, patient feedback and aspects to improve. This was achieved within five years of starting the new program. 11
Slide 13: Manufacturing agreements for commercial supply
For personal use only In the past 12 months the company has finalised the necessary manufacturing agreements to ensure commercial supply of SCENESSE® (afamelanotide). • Key suppliers are Solvay – Peptisyntha for drug substance • Brookwood-Evonik Industries GmbH for drug product • CUV proprietary pro
Slide 14: Protocol design
For personal use only Protocol design. Our confirmatory EPP study protocols were designed in direct response to and in conjunction with regulatory feedback from the EMA (protocol assistance). 13
Slide 15: EPP filing at EMA: considerations
For personal use only EPP Filing at EMA, what are their considerations? The EMA have placed importance on the concept of clinical relevance during their review of SCENESSE® as an orphan designated drug. 14
Slide 16: First results showing clinical relevance in US EPP patients
For personal use only We have now released the first of these results showing the drug to be clinically relevant for EPP in US patients. Full results can be accessed on our website. 15
Slide 17: Patient feedback from the CUV030 study
For personal use only Direct feedback from patients involved in the CUV030 study suggest that the drug is of clinical benefit. 16
Slide 18: First results in nonsegmental vitiligo
For personal use only Exciting first results were recently reported on nonsegmental vitiligo (NSV): Afamelanotide 16 mg in combination with NB-UVB seems to accelerate and deepen pigmentation in NSV patients. The various forms of repigmentation are seen within patients. Evaluation of all patients wil
Slide 19: EMA review process timelines
For personal use only What to expect: timelines EMA review process. There is a set timeline to EMA review which includes ‘clock stop’ periods for questions. This timeline provides a framework for planning. In recent years orphan drugs evaluated by the EMA have taken 6-12 months to review, with an av
Slide 20: Near-term value drivers
For personal use only A number of near term value drivers are imminent, with safety results from CUV032 and CUV011 to be included in EMA dossier. 19
Slide 21: Summary
Summary * Developing novel therapies for severe skin disorders — Expertise in the interaction of light and human skin — Two lead indications (EPP 10,000; nonsegmental vitiligo approx. 45m pats.) SCENESSE® first-in-class for photoprotection in EPP and phototherapeutic treatment in vitiligo — Encourag
Slide 22: Thank you to staff, Board and shareholders
thank you to dedicated Clinuvel staff and Board appreciation of shareholders for their continuing confidence in developing SCENESSE® to market 21
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