5. data and comments. 5, page-85

re: 5. frequently asked questions ( faq).5 frequently asked questions
1. What is tanning?
2. What is Melanotan?
3. Why should I use Melanotan?
4. When will Melanotan be available?
5. How will I take it?
6. Will I need a prescription or will I buy Melanotan over the counter (OTC)?
7. Will Melanotan replace sunscreens?

8. I have read that no tanning is safe. Why is Melanotan safe?
9. I have fair skin and don’t tan. Will Melanotan help me tan?
10. Will Melanotan stop the growth of melanoma?
11. How is Melanotan different to tanning pills and lotions?
12. What is EpiTan’s patent and trademark position?
13. Does Melanotan effect weight loss and erectile dysfunction?
14. How can I volunteer for the clinical trial program?
15. Can Melanotan help people with skin disorders such as PMLE, solar urticaria and vitiligo?

1. What is tanning?
Tanning happens when ultraviolet (UV) light from the sun or a solarium comes into contact with the skin. This causes the natural substance alpha-MSH to be released
by the body and stimulate tanning cells in the skin called melanocytes. These in turn produce melanin, the pigment responsible for the brown colour of tanned skin.

2. What is Melanotan?
Melanotan is a synthetic copy of the body's own alpha-MSH, but more potent.
Melanotan stimulates the production of melanin without the need for excessive UV light. It gives the skin its tanned appearance while also acting like an internal
sunscreen, protecting the skin against injury from further UV exposure from the sun or solarium.

3. Why should I use Melanotan?
Under normal circumstances if a person is exposed to UV light, melanin takes several days to form a protective barrier, particularly in fair-skinned people. During this time the skin is especially vulnerable to sunburn, repeated episodes of which contribute to the development of skin cancer.
Melanotan, however, enables melanin to form before exposure to dangerous levels of UV. This new technology will benefit people with fair skin who are most at risk of sunburn injury and therefore of developing skin cancer.

4. When will Melanotan be available?
Melanotan is scheduled to be available in 2006, after the successful completion of clinical trial programs and registration with regulatory authorities.

5. How will I take it?
A clinical trial is currently being conducted in Queensland, Australia using a small sustained release solid injectable that will most probably be injected into the skin under the arm. This will slowly dissolve over a few days releasing a steady stream of Melanotan into the body allowing the appropriate level of melanin to form. Other formulations being investigated include a gel/lotion and patch.

6. Will I need a prescription or will I buy Melanotan over the counter (OTC)?
Melanotan will only be available by prescription because it is a systemic drug and therefore is under government regulation.

7. Will Melanotan replace sunscreens?
No, EpiTan does not recommend replacing sunscreens with Melanotan. Melanotan will be used alongside other sun-smart measures to maximize protection from
harmful UV exposure. If applied thoroughly and regularly, sunscreens are quite effective in blocking UVB
light and preventing sunburn.

However, it is difficult to ensure adequate coverage is maintained, particularly while swimming or exercising.
Recent studies have also shown that many sunscreens are less effective in protecting against UVA radiation, which may be a significant factor in causing melanoma, the most aggressive form of skin cancer (1-2).
To ensure the best protection from sunburn injury and skin damage, use Melanotan together with a sunscreen and protective clothing and avoid the sun during the
middle of the day.

(1) Nita S. Agar , Gary M. Halliday, Ross StC. Barnetson, Honnavara N. Ananthaswamy, Mark Wheeler, and Alexandra M. Jones. The basal layer in human squamous tumors harbors more UVA than UVB fingerprint mutations: A role for UVA in human skin carcinogenesis. Proceedings of the National Academy of
Sciences, published online before print March 23, 2004.

(2) Rachel Haywood, Peter Wardman, Roy Sanders, and Claire Linge. Sunscreens Inadequately Protect Against
Ultraviolet-A-Induced Free Radicals in Skin: Implications for Skin Aging and Melanoma? Journal of Investigative
Dermatology Volume 121 Issue 4 Page 862 - October 2003.

8. I have read that no tanning is safe. Why is Melanotan safe?
Until Melanotan there was no such thing as a safe tan.
Prolonged exposure to UV radiation results in sunburn and skin ageing (wrinkles), which can lead to the development of skin cancer.
Melanotan allows you to get a normal, natural tan without spending excessive time in the sun or at the solarium.
This is of particular benefit to fair-skinned people who usually have a lot of difficulty tanning and a high risk of sunburn injury.

9. I have fair skin and don’t tan. Will Melanotan help me tan?
Yes. Results from EpiTan’s 2003 sunburn injury trial proved conclusively that fair-skinned
people, who normally burn rather than tan, demonstrated the highest
increase in melanin density over the course of the study.
Key findings included:
• Melanin density increases as high as 100% in fair-skinned volunteers in
particular.
•
Sunburn injury was reduced by more than 50% in fair-skinned volunteers.
This is the first time that the level of melanin could be increased in the skin by
means other than by damaging the cells with sunburn. It is also the first time that a
drug has been demonstrated to induce a protective level of melanin in people who
normally cannot make any significant amounts of melanin.

10. Will Melanotan stop the growth of melanoma?
Overall, published and unpublished studies show that Melanotan has either no effect
on melanoma growth or inhibits melanoma growth depending upon the experimental
conditions (1-4). In fact, Melanotan may act in an anti-inflammatory capacity to
oppose the spread of tumor (1).
There is no evidence that normal melanocytes will change into melanomas with the
use of Melanotan.
EpiTan will continue to monitor the effects of Melanotan on melanocytes throughout
the clinical development program.
(1) Zhu,N. et al. Melanoma cell attachment, invasion, and integrin expression is upregulated by tumor necrosis factor
alpha and suppressed by alpha melanocyte stimulating hormone. J. Invest Dermatol. 119, 1165-1171 (2002).
(2) Smalley,K. & Eisen,T. The involvement of p38 mitogen-activated protein kinase in the alpha-melanocyte stimulating
hormone (alpha-MSH)-induced melanogenic and anti-proliferative effects in B16 murine melanoma cells. FEBS Lett.
476, 198-202 (2000).
(3) Brady B.M, Bemis L., Gibbs P & Robinson W.A. Alpha MSH inhibits human m

11. How is Melanotan different to tanning pills and lotions?
Melanotan is not like tanning pills and lotions. It is the only drug designed to increase the concentration of melanin in the skin and backed by exhaustive human
clinical trials.
Tanning lotions use a chemical process to stain the surface layer of the skin. The resulting colour is temporary and is sloughed off over a period of several days.
Tanning pills use vegetable based chemicals to tint the skin by saturating the fat layers just below the skin surface with pigment. These include carotene from carrots (which turns the skin orange/bronze) and lycopene from tomatoes (which has a
red/bronze colour).
The tan provided by tanning lotions and pills offers no protection from harmful UV light.

12. What is EpiTan’s patent and trademark position?
The Melanotan technology is supported by a strong patent position in the major jurisdictions around the world. There are 34 patents currently in force with a further international patent application filed in February 2003.

It is also anticipated that current R&D and clinical trial programs will generate new intellectual property enabling further patent applications to be filed.
EpiTan also has an excellent and aggressive drug life cycle management strategy designed to prolong Melanotan’s market exclusivity.

13. Does Melanotan effect weight loss and erectile dysfunction?
No. Melanotan is being developed solely for the purpose of increasing melanin production in the skin. It has no effect on weight loss, erectile dysfunction, hair or
eye colour.

14. How can I volunteer for the clinical trial program?
Click here to go to the registration form for potential volunteers. You will be contacted should a trial take place in your area.
You can also keep up to date with clinical trial progress by registering for email alerts on the volunteer registration page.

15. Can Melanotan help people with skin disorders such as PMLE, solar urticaria and vitiligo?
EpiTan is confident that Melanotan will alleviate or cure some skin disorders.
The company expects to start a clinical trial for PMLE in 2004.
For sufferers of vitiligo, EpiTan is developing a lotion formulation which will be able to be applied directly to the non-pigmented areas of skin and may help the
condition. A prototype lotion is expected to be ready for trials this year.
END