Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Shareholder Meeting (November 2013)
35 slides from Clinuvel Pharmaceuticals's shareholder meeting presentation, Nov 12, 2013
Slide 1: For personal use only
For personal use only As the Company awaits the final stage in the pharmaceutical development cycle – marketing approval by a leading regulatory agency – an in‐depth review of the history of the molecule and role of the management, and a preview of the next steps are given. 1
Slide 2: For personal use only
For personal use only This presentation includes statements which can be interpreted as forward looking. Investors are encouraged to read and understand the risks inherent in developing SCENESSE® ‐ the first global melanocortin in clinical development ‐ which may affect the performance and results o
Slide 3: For personal use only
For personal use only The agenda for today will comprise of all essential activities by Clinuvel, and those which should be of interest to shareholders of the Company. 3
Slide 4: Melanocortins and afamelanotide
For personal use only Melanocortins, molecules which act on various melanocortin receptors, are well understood, yet none has been developed or approved to date in a pharmaceutical formulation. Clinuvel works in a novel territory in which afamelanotide – the active ingredient in SCENESSE® – is the f
Slide 5: For personal use only
For personal use only Most pharma projects targeting melanocortin receptors have been abandoned over the years. The main industry focus has been to target MC4R and MC3R. 5
Slide 6: For personal use only
For personal use only Clinuvel’s scientific teams are still frequently asked whether alternative formulations, modes of administrations and routes would not be preferable for SCENESSE®. A misconception still exists that the biological alpha‐MSH could exert a similar activity as SCENESSE®. This table
Slide 7: For personal use only
For personal use only Clinuvel’s clinical objectives since 2005 have been clear, consistent and mostly achieved. Regulatory requirements and priorities are defined as seeking novel treatments for diseases with unmet clinical need for groups of patients who deserve or are entitled to a therapy. In de
Slide 8: For personal use only
For personal use only Clinuvel’s clinical program has pursued those indications where scientific evidence, clinical need and regulatory support is the strongest. This has led to the focus on erythropoietic protoporphyria (EPP) and vitiligo as the Company’s main indications. Science is the only crite
Slide 9: For personal use only
For personal use only The European Medicines Agency’s (EMA’s) evaluation of SCENESSE® is now one of the three longest ongoing reviews in the Agency’s history, as per publications by the EMA. There are two overarching questions being answered by the EMA. Firstly is one of benefit versus risk: does th
Slide 10: For personal use only
For personal use only Analysis of the EMA’s track record of new drug approvals shows a clear trend towards, and in favour of, life‐threatening and severe disorders. EPP is discussed in context of the current regulatory climate. 10
Slide 11: For personal use only
For personal use only It is of use to analyse the EMA approvals, those severe disorders which make comparison with EPP of relevance. In this list of approvals, special attention is required for the treatment of PDT (a form of iatrogenic EPP) with Gliolan, and Nexobrid for the treatment of burn wound
Slide 12: For personal use only
For personal use only Based on the review and feedback from the Agency to date, we expect the EMA’s review to restart in January ‘14, leading to a CHMP meeting on SCENESSE® in Q1/Q2 2014. An Oral Presentation to the EMA is anticipated. An Expert Meeting between EMA, patients and physicians expressin
Slide 13: Compassionate use
For personal use only Compassionate use – supplying the drug to patients on a compassionate basis outside of studies – was long discussed and strongly supported by Clinuvel’s Board. Not only did this allow patients access to much needed treatment – fulfilling the mantra to ‘do good’ – this program a
Slide 14: Safety
For personal use only Safety deserves Clinuvel’s full attention in the development program of SCENESSE®. 14
Slide 15: Videoclip: EPP patient interview
VIDEOCLIP 6 MINUTES: EPP PATIENT GERMAN INTERVIEW EXPERIENCES WITH DISEASE EXPERIENCES WITH DRUG in SWITZERLAND THE PATIENT HAS NOT BEEN SPONSORED, INVITED OR INCENTIVISED BY CLINUVEL TO GIVE THIS INTERVIEW THE INTERVIEW WAS INITIATED BY A GERMAN BROADCASTER CLINUVEL HAS NOT ORGANISED OR ENTICED PAT
Slide 16: For personal use only
For personal use only To date, results in EPP have shown the drug is well tolerated and enables patients to lead a normal outdoors existence, gradually increasing their time outdoors in light and sun. However patients are conditioned since childhood to avoid any risk of light exposure. EPP patients
Slide 17: For personal use only
For personal use only CUV039 results show that SCENESSE® improves the patients’ ability to expose to light and sun, and engage in activities not possible prior to treatment. The EPP validated QOL shows a favourable difference for those patients who received the drug. 17
Slide 18: For personal use only
For personal use only To date, results in EPP have shown the drug is well tolerated. Safety is a focus of the company, and each adverse event is scrutinised, followed up and discussed with the respective physicians. The list shows the unedited list of all top ten – most common – adverse events follo
Slide 19: For personal use only
For personal use only A significant burden is placed on patients to participate in clinical trials, with the average patient travelling more than 400 miles to attend clinics in the US. The patients’ motivation and persistence is reflected in these numbers. Clinuvel’s efforts over the years to organi
Slide 20: For personal use only
For personal use only Drug utility in Switzerland and Italy provides valuable information and lessons for distribution of SCENESSE®: patients remain on drug year‐on‐year. 20
Slide 21: For personal use only
For personal use only The share price of CUV has peaked twice, an historical account is given. Volume increased in 2004 and 2005. No substantial news flow supported the share price in 2004 or 2007. The rally in share price caused demand for the stock and resulted in two major capital raisings in 200
Slide 22: For personal use only
For personal use only Management has raised >A$82M since 2005 to fund the current clinical and regulatory program for SCENESSE®. 22
Slide 23: For personal use only
For personal use only The MCAP is a function of the ASX share price and does not reflect the IV at each stage of the Company. 23
Slide 24: For personal use only
For personal use only Cash expenditure has been managed with care and attention throughout the period. 24
Slide 25: For personal use only
For personal use only Monthly cash management is imperative throughout the entire development of a decade, predictability of operational expenditures deserves full attention at CUV: in this context maintaining a flat line is preferable. 25
Slide 26: For personal use only
For personal use only Equity is distributed approximately: Australia 25% : US 35% : EU/CH 25% : ASIA 15% 26
Slide 27: For personal use only
For personal use only Innovation comes in many forms, not only developing a new molecular entity in a new formulation. Clinuvel had to develop instruments, scientific tools, communities and the environment to be able to provide a market position for SCENESSSE®. 27
Slide 28: Vitiligo
VITILIGO ‘All images courtesy of the Vitiligo and Pigmentation Institute of Southern California. Images cropped to maintain patient privacy but are otherwise unaltered Repigmentation with afamelanotide/NB-UVB combination Phase Ila US pilot study (CUV102) complete SCENESSE® used as combination therap
Slide 29: Repigmentation pattern - CUV102
REPIGMENTATION PATTERN — CUV102 New York site, Group A (active) Day 0 Day 27 Day 55 Day 111 Baseline After 9 NBUVB After 15 NBUVB After 27 NBUVB treatments treatments, 1 implant treatments, 3 implants Day 176 After 40 NBUVB treatments, 4im. Clinuvel 29
Slide 30: For personal use only
For personal use only Close up reveals the follicular appearance of repigmentation ‘islands’ throughout the epidermis. 30
Slide 31: For personal use only
For personal use only Having understood the role social media was beginning to play globally, Clinuvel increased its online activities, focusing on patients and the general public. Data source: Yahoo! news 31
Slide 32: For personal use only
For personal use only In parallel to developing online infrastructure, the company identified and commenced working with specialist EPP centres globally as well as research centres specialising in melanin, photodermatology, photobiology and related fields. Clinuvel saw the role social media would pl
Slide 33: For personal use only
For personal use only The Company has consolidated its social media position, with patient communities growing and becoming pro‐active in studies. Cross‐border/language connections have helped patients feel part of a community. YouTube interest, particularly for vitiligo program, indicates great pot
Slide 34: For personal use only
For personal use only In entering new indications, new markets, it helps to look across the field of dermatology and assess the value of assets. Clinuvel is developing a product which is, strictly speaking, treating dermal symptoms while EPP patients are treated mainly by gastroenterologists, haemat
Slide 35: Conclusions
CONCLUSIONS Safety profile SCENESSE® excellent Strong academic & patient demand SCENESSE® Drug Utility: CH-ITA 6-7 years of value EPP is self-limiting disease — QoL improved significantly — exposure time gradually increases — clinical relevance SCENESSE®: loss of deeply rooted anxiety + adopt a new
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