Post on 18-Dec-2014
description
An emerging biotechnology company with a focus on:
December 2002EpiTan Limited
Melbourne, Australia
drug development to reduce the incidence of skin cancer; and
the manufacture and distribution of dermatology products.
Page
Market data 3
The business 4
Trial results 5
Planned trials 9
Current project plan 10
Market size 11
Other initiatives 12
Upside 13
Executional ability 15
Fundraising 16
Current financial position 17
Summary 18
Appendix I - Comparable companies 19
Contents
2
ASX Ticker: EPTListed: February 2001Current price: $0.13Current capital structure: Issued Escrow Trading
(Feb. ‘03)
Shares (m) 86.4 38.0 48.4Options (m) Ordinary (ex price 30 cents) (m) 60.2 23.1 37.1 Incentive scheme (m) 6.1 Ordinary options expire 30 June 2003Shareholding: 1340 shareholders 40% held by 2 largest shareholders (escrowed)Market capitalisation (at $0.13): $11.2 million12 Month High/Low: $0.32 / $0.05
Market data
3
Exclusive worldwide development and commercialisation rights to Melanotan.
Melanotan has the potential to reduce skin damage (caused by the sun) by
stimulating the body’s own protective tanning mechanism.
Skin damage often leads to skin cancer, the most common of all cancers.
Inverse relationship between the incidence of skin cancer and pigmentation of
the skin is well documented.
EpiTan holds patents covering the structure and method of application of
Melanotan in the major jurisdictions.
Ongoing research and development, particularly in drug delivery, will lead to
further intellectual property protection.
The business
4
Physician’s Investigational New Drug (IND) Trials (FDA approved) on 100 human volunteers conducted in Arizona (USA) in the 1990’s.
IND Trials demonstrated safety and showed a small dose of Melanotan given daily over 10 days produces a 4-6 week tan.
Phase I/II clinical trial successfully completed at Royal Adelaide Hospital in March 2002.
Phase I/II trial showed Melanotan caused a statistically significant increase in skin melanin density.
Minor side effects, including mild nausea, injection site irritation and transient facial flushing, related to the mode of administration and drug formulation, which are now able to be resolved by the Company.
Trial results
5
Preclinical animal trials
Light-coloured hair regrowth upon cessation of treatment
No Melanotan
No Melanotan
Following Melanotan treatment
6
No MelanotanThree weeks of
Melanotan treatment
Arizona IND studies
7
-0.15
0
0.15
0.3
0.45
0.6
Forehead Left Cheek Right side ofNeck
Left Shoulder(Scapula)
Right InnerUpper Arm
Left MedialForearm
Right side ofAbdomen
Left Calf
Cha
nge
in %
Mel
anin
Den
sity
Melanotan Day 9 Melanotan Day 30 Placebo Day 9 Placebo Day 30
Baseline Corrected MelaninDensity Values on day 9 and 30
Phase I/II clinical trial results Melanin Density
8
Phase IIb clinical trial commenced in November 2002 (80 subjects).
One objective to measure the effect of Melanotan on reducing the incidence of sunburn
cells after controlled UV exposure.
Clinical trials of a sustained release formulation of Melanotan anticipated to commence
in early 2003.
Sustained release formulation:
being developed in collaboration with the Southern Research Institute (Alabama, USA);
will reduce levels of drug required (a single dose will provide protection of up to 6
months); and
will eliminate side effects noted in Phase I/II clinical trials.
Clinical trial schedule
9
Current Melanotan project plan
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Phase IIb clinical trials
Partnering discussions with "big pharma"
Slow release formulation clinical trials
Phase III clinical trial
Marketing application
Available to market
20062002 2003 2004 2005
10
No other comparable drug known to be in clinical trials.
Global dermatology market well over US$1.5 billion per annum.
Cosmetic market (“fake tanning” stains / dyes and solariums) estimated at >US$5 billion per
annum worldwide.
A$500 million per annum in skin cancer treatment costs in Australia and rising.
Other potential therapeutic indications for Melanotan:
- Vitiligo - Polymorphous Light Eruptions
- Albinism - Porphyria
- Xeroderma Pigmentosa
Market size
11
Expansion into new leading-edge dermatology products to generate
revenues in the short-term.
Appointment of a US-based consultant to source new products for
distribution in the Australasian region.
Appointment of Mr Stan McLiesh (former General Manager -
Pharmaceuticals for CSL Limited) to the Board.
Mr McLiesh brokered numerous in-licensing agreements with
international companies, enabling CSL to expand into new markets.
Other initiatives
12
Share price appreciation to come from:
Phase IIb trial development:
Currently only 13 ASX-listed companies with drugs in Phase II clinical trials;
Of these, EpiTan has one of the lowest market capitalisations (refer Appendix I);
Phase IIb trials commenced in November; and
EpiTan’s trials conducted at a fraction of the cost of other clinical trials because Melanotan is a preventative drug rather than a therapeutic.
Revenue streams now being developed:
Company is currently investigating several in-licensing opportunities for dermatology products for distribution in Australia and New Zealand.
Upside
13
Partnering:
Following successful completion of Phase I/II trials, approaches to consider
partnering have come from “Big Pharma”. A partnering deal could result in:
recoupment of certain project expenditure
substantial project funding;
shortening of time to market;
additional technical support;
global product distribution capability; and
increased credibility / profile.
Upside continued
14
Board of Directors: Dr. Wayne Millen BSc(Hons) PhD FRACI C.CHEM AFAIM CHAIRMAN and CEO
Dr. Helmer Agersborg BS PhD DEPUTY CHAIRMAN
Dr. Terry Winters BSc PhD NON-EXECUTIVE DIRECTOR
Clinical Assoc. Prof. Alan Cooper OAM, BSc MBBS FACD Dip.Amer.Brd.Derm NON-EXECUTIVE DIRECTOR
Mr Stanley McLiesh BEd NON-EXECUTIVE DIRECTOR
Management and consultants
Dr. Stuart Humphrey BSc PhD MANAGER–CLINICAL DEVELOPMENT
Mr. Michael Kleinig BAppSc MANAGER-PHARMACEUTICAL DEVELOPMENT
Professor Robert Dorr BS MS PhD RPh TECHNICAL CONSULTANT Professor of Pharmacology and Director of the Pharmacology Research Program at the Arizona Cancer Center, USA
Professor Terry Dwyer AM MB BS MPH MD TECHNICAL CONSULTANT Director of the Menzies Centre for Population Health Research
Mr Thomas Laughlin BA MBA IN-LICENSING CONSULTANT
Executional ability
15
Shareholder approval has been obtained to issue up to 20 million new
ordinary shares via a placement.
Pricing to be determined (no less than 80% of average market price).
Funds raised to be applied to:
accelerate development of Melanotan;
dermatology products operation; and
working capital.
Fundraising
16
Cash at bank - 1 July 2002 - $4.4 million.
Cash budget - FY’03:
$ million
Cash at 1 July 2002 4.41
Projected income (interest, GST refund) to 30 June 2003 0.50
Total 4.91
Preclinical & clinical studies (1.8)
Drug formulation and development (1.4)
Suppliers, employees, corporate (1.4)
Net surplus – 30 June 2003 0.3
The above does not allow for any revenues generated from the in-licensing and
distribution of dermatology products.
Current financial position
17
Innovative technology.
Granted world patents, licence and trademarks.
Phase I/II clinical trial successfully completed in March 2002.
Phase IIb clinical trial commenced in November 2002.
Major international market US$6.5 billion+ per annum.
Potential partnering with “Big Pharma”.
In-licensed product opportunities being developed.
World-class board and management team.
Strong financial position as at 1 July 2002.
Summary
18
Appendix I - Comparable companies
116 >1,000 Phase II Alzheimer’s Disease Clioquenol Prana Biotechnology
36 >1,000 Phase II Skin cancer / Melanoma therapy
Macrocyclic diterpenes
Peplin Biotech Limited
108 >1,000 Phase II Obesity hGH Peptide Metabolic Pharmaceuticals
16 >5,000 Phase II Colon / Breast cancer / Skin cancer therapy
Hyaluronan Meditech Research
11 3,000 (10,000)
Phase II Skin cancer reduction (sunless tanning)
Melanotan EpiTan Limited
Market cap. (A$million*)
Market size (A$million)
Development Stage Medical Indication Product Company
* Includes market capitalisation of restricted shares
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