EPITAN - Clinuvel Pharmaceuticals

EPITANProphylacticThis is potentially the largest pharmaceutical market for MELANOTAN with the keyindication being the prevention of sunburn injury in the at risk population. The targetpopulation can be broadly defined as Caucasians with fair skin. However, using theFitzpatrick skin type classification (classifying individuals by their skin sensitivity tosunlight) the target population can be further defined as people with Fitzpatrick types Iand II. These people are at the highest risk for photoaging effects, including wrinkles,and are more importantly at most risk of developing skin cancer. Therefore protectionof this population from sunburn injury during periods of the highest exposure to UVlight should produce a major clinical benefit. This indication is less well defined thanthe therapeutic indications, and late stage clinical trials to demonstrate efficacy willhave to be larger in terms of patient numbers in order to convince regulatory authoritiesof the clinical benefits. EpiTan is attempting to further define the target population bygenotype which should be of benefit when regulators are assessing the product forapproval. Peak sales in this market have the potential to be in excess of $1bn, makingthe commercial rationale for developing the product in this field clear.Skin cancer is a major global health issue affecting millions of lives and costingeconomies billions of dollars in treatment and loss of production. Data from the WorldHealth Organisation published in 2003, estimates that between two and three millionnon-melanoma skin cancers and over 130,000 malignant melanomas occur globallyeach year, and predicts that these numbers are rising.Rates of incidence of melanoma are continuing to increase throughout the EuropeanCommunity. In Germany alone the incidence of skin cancer has increased twenty-foldsince 1930 according to the European Society of Skin Cancer Prevention.Australia has the highest rate of skin cancer in the world. One out of every twoAustralians will develop skin cancer at some stage during their lives. On average,740,000 new cases of skin cancer are diagnosed in Australia every year.7