Already working on protecting white folks so they can move in droves into Sub-Saharan Africa:
EpiTan Limited has a pre-eminent position in the development of new technology for reducing UV-related skin damage.
EpiTan’s unique technology platform is centred on its leading drug candidate Melanotan®. The company has the exclusive worldwide rights to develop Melanotan which, like sunlight, stimulates the production of melanin in the skin resulting in a tan.
Tanning occurs when ultraviolet (UV) light from the sun or a solarium comes into contact with the skin. This causes the natural substance a (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.
Melanotan is a synthetic copy of the body's own a-MSH, but is more potent. It stimulates the production of melanin without the need for excessive UV light, giving 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.
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 circumvents the natural tanning process by triggering melanin production 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.
Phase II clinical trial results for Melanotan have shown that, for the first time, a drug can achieve a 50% reduction in sunburn injury and melanin density increases as high as 100% following UV exposure in fair-skinned volunteers in particular.
EpiTan has also developed a user-friendly drug delivery formulation for Melanotan in the form of
a sustained release solid injectable which will 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.
Potential markets worldwide for Melanotan for dermatology purposes are estimated at US$2.5 billion. An even greater market (more than US$5 billion) exists for Melanotan as a new safe (sunless) tanning drug.
Competitive advantages
Epidemiological studies have clearly associated increased levels of melanin with reduced incidences of skin cancer. Therefore, if the amount of melanin in the skin can be controlled, there is a potential to reduce skin damage and subsequently decrease the risk of skin cancer.
An increased level of melanin in the skin is commonly referred to as a ‘tan’. EpiTan’s key objective is to use Melanotan to increase the concentration of melanin in the skin without the need for exposure to harmful levels of sunlight. Consequently, EpiTan is in a unique position to enter both the global sunscreen and tanning markets.
Skin cancer is the most prevalent of all cancers in the world and a major global health issue affecting millions of lives and costing economies billions of dollars. In the US alone, US$1.1 billion per annum is spent on treatment costs.
The increasing awareness that UV exposure is the primary cause of skin damage and skin cancer drives the global industry for sun care products. US sales of sun protection products are in the order of US$0.44 billion per annum.
Alongside increasing skin cancer awareness is the escalating popularity of tanning. Surveys show that while more people are aware of the dangers of unshielded exposure to UV radiation, the desire to be fashionable outweighs their health concerns. This is evidenced by the rapid growth of the global tanning salon industry.
In the USA, The American Academy of Dermatology estimates greater than one million Americans are visiting tanning salons every day. Other figures quote that in 2001, there were approximately 28 million visits made to 25,000 solariums. The market for tanning in salons in the US is estimated at US$2 billion dollars per annum with a further US$100 million spent on self-tanning products.
Other potential markets for Melanotan are as a therapeutic drug for treatment of various dermatological disorders in which UV radiation may play a part including psoriasis, vitiligo, polymorphous light eruption and solar urticaria. This market has a potential value of US$1 billion per annum.
Technology/Services
Because of its instability, natural a-MSH is unsuitable as a drug. Melanotan, the synthetic analogue of a-MSH was chemically prepared at the University of Arizona and has two changes introduced into the a-MSH molecule to produce Melanotan. Norleucine (Nle4) is substituted at the No. 4 position, and the No. 7 AA is D-Phenylalanine (D-Phe7). Both substitutions enhance potency considerably.
In in-vitro skin pigmentation assays, Melanotan is 1,000 times more active than natural -MSH. Melanotan is also highly resistant to enzymatic degradation, yielding a much longer plasma half-life in humans.
When preclinical studies with Melanotan demonstrated that it had no obvious toxic effects clinical trials to demonstrate tanning of the skin in humans were carried out under an IND program in Arizona. The Arizona team was encouraged to find that Melanotan induced a tan in the volunteers which was slowly produced in the same way as a natural tan and persisted for a similar time.
The results were published in the Journal of the American Association in 1991 (Vol 266; 2730-2736) and this was the first demonstration of a stable drug candidate that could induce a natural tan in human beings. Importantly, further studies showed that the melanin produced by the volunteers was the photoprotective pigment, eumelanin (Photochemistry and Photobiology, 2000, Vol 72; 526-532).
In addition to the more than 100 volunteers treated under the Arizona IND programme, EpiTan has now treated a further 71 volunteers in Australia in two studies and added to the safety data as well as providing strong evidence for the
protective nature of the induced skin melanin against the harmful rays of the sun. The most recent study results showed that skin melanin could be nearly doubled in some fair-skinned volunteers (who are most at risk of sunburn injury) and that increased melanin was associated with a halving of the cell damage caused by UV exposure at three times their minimal erythema (skin reddening) level.
Melanotan is scheduled to be
available in 2006, after the successful completion of clinical trial programs and registration with regulatory authorities.
Corporate Alliances/Partnerships
Since its formation, EpiTan has worked diligently to establish strong collaborative research partnerships with leading researchers in the fields of cancer research, drug delivery and epidemiology.
Australian research partnerships are with Monash University and the Institute of Medical and Veterinary Science. The company also works collaboratively with the
Menzies Centre for Population Research. (??)
EpiTan has the exclusive right to any intellectual property developed under the research agreements with Monash University and IMVS and expects new patents to be filed as a result of this work.
The company has an on-going relationship with the inventors of Melanotan including Professor Robert Dorr, Professor of Pharmacology and Director of the Pharmacology Research Program at the Arizona Cancer Center who is a consultant with the company.
EpiTan has also appointed Dr Perry Robins, an eminent New York-based skin cancer specialist, to facilitate the expansion of EpiTan's clinical trials into the USA and Europe. Dr Robins is Professor of Dermatology and Chief of the Mohs Micrographic Surgery Unit at New York University Medical Center and founder and president of the Skin Cancer Foundation, an international organisation dedicated to skin cancer research and education.
Partnering opportunities
EpiTan is pursuing partnering opportunities to expand its product base and accelerate its clinical trial, drug development and commercialisation programs.
Contact
Iain Kirkwood
Job Title
Chief Administrative Officer
Address
[align=left]Level 10 52 Collins Street[/align]
City/Suburb
[align=left]Melbourne
Victoria 3000 Australia[/align]
Email
[align=left]iain.Kirkwood@epitan.com.au[/align]
Phone
+61 3 9662 4688
Fax
+61 3 9662 4788
Website
www.epitan.com.au