PEPLIN has achieved positive results for a topical gel that treats sun spots, in the first of phase III trials. Managing director for Peplin Australia Peter Welburn says the trials meet all of the requirements of the Food and Drug Administration (FDA) in the US.
Welburn says the Brisbane-based company’s PEP005 Gel can be used to treat the common pre-cancerous condition of solar keratosis with shorter course and skin reaction times.
“What makes our product so unique is that it takes two or three days treatment versus one to two months treatment with existing products – secondly, skin responses are basically over within two to four weeks,”
Welburn is reluctant to give a market value once the drug has been approved because it will depend on price, but he cites existing topical gels in the US as costing between $400 to $800 per course.
The trials were conducted in Australia and the US with 255 randomised patients and tested reactions non-head areas such as the arms, the back of the hands and the chest, which Welburn says are notoriously difficult to treat and represent about 30 per cent of cases.
“The bigger part of the market is for the face and scalp and we’re starting the FDA’s final phase III studies this month and should be finished by the end of this year – if these trials go as well as then we anticipate approval in 2011.”
CEO Tom Wiggans says the milestone shows that Peplin is on its way to becoming a fully integrated commercial organisation.
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