An emerging biotechnology company with a focus on:

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An emerging biotechnology company with a focus on: December 2002 EpiTan Limited Melbourne, Australia drug development to reduce the incidence of skin cancer; and the manufacture and distribution of dermatology products.

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Transcript of An emerging biotechnology company with a focus on:

Page 1: An emerging biotechnology company with a focus on:

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.

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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

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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

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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

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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

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Preclinical animal trials

Light-coloured hair regrowth upon cessation of treatment

No Melanotan

No Melanotan

Following Melanotan treatment

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No MelanotanThree weeks of

Melanotan treatment

Arizona IND studies

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-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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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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