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An emerging biotechnology company with a focus on:

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Title: An emerging biotechnology company with a focus on:


1
An emerging biotechnology company with a focus on
  • drug development to reduce the incidence of skin
    cancer and
  • the manufacture and distribution of dermatology
    products.

December 2002EpiTan LimitedMelbourne, Australia
2
Contents
  • 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

2
3
Market data
  • ASX Ticker EPT
  • Listed February 2001
  • Current price 0.13
  • Current capital structure Issued Escrow Trading
  • (Feb. 03)
  • Shares (m) 86.4 38.0 48.4
  • Options (m)
  • Ordinary (ex price 30 cents) (m) 60.2 23.1 37.1
  • Incentive scheme (m) 6.1
  • Ordinary options expire 30 June 2003
  • Shareholding
  • 1340 shareholders
  • 40 held by 2 largest shareholders (escrowed)
  • Market capitalisation (at 0.13) 11.2 million
  • 12 Month High/Low 0.32 / 0.05

3
4
The business
  • Exclusive worldwide development and
    commercialisation rights to Melanotan.
  • Melanotan has the potential to reduce skin damage
    (caused by the sun) by stimulating the bodys 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.

4
5
Trial results
  • Physicians Investigational New Drug (IND) Trials
    (FDA approved) on 100 human volunteers conducted
    in Arizona (USA) in the 1990s.
  • 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.

5
6
Preclinical animal trials
No Melanotan
Following Melanotan treatment
No Melanotan
Light-coloured hair regrowth upon cessation of
treatment
6
7
Arizona IND studies
Three weeks of Melanotan treatment
No Melanotan
7
8
Phase I/II clinical trial results Melanin Density
Baseline Corrected MelaninDensity Values on day
9 and 30
8
9
Clinical trial schedule
  • 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.

9
10
Current Melanotan project plan
10
11
Market size
  • No other comparable drug known to be in clinical
    trials.
  • Global dermatology market well over US1.5
    billion per annum.
  • Cosmetic market (fake tanning stains / dyes and
    solariums) estimated at gtUS5 billion per annum
    worldwide.
  • A500 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

11
12
Other initiatives
  • 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.

12
13
Upside
  • 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
  • EpiTans 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.

13
14
Upside continued
  • 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.

14
15
Executional ability
  • 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 MANAGERCLINICAL
    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

15
16
Fundraising
  • 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.

16
17
Current financial position
  • Cash at bank - 1 July 2002 - 4.4 million.
  • Cash budget - FY03
  • 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.

17
18
Summary
  • 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
    US6.5 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.

18
19
Appendix I - Comparable companies
Includes market capitalisation of restricted
shares
19
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