SolarazeR receives approval in Australia
SkyePharma's SolarazeR, its topical 3% gel (diclofenac sodium) treatment for actinic keratosis, has been approved for registration by the Australian Government Department of Health and Ageing Therapeutic Goods Administration (TGA).
SkyePharma's SolarazeR, its topical 3% gel (diclofenac sodium) treatment for actinic keratosis, has been approved for registration by the Australian Government Department of Health and Ageing Therapeutic Goods Administration (TGA).
Actinic Keratoses (AKs) are an early stage skin cancer recently defined by the European Dermatology Forum as in situ squamous cell carcinoma (SCC).
AK is the most frequently occurring form of carcinoma in situ and has approximately a 10% risk of developing into invasive squamous cell carcinoma.
SkyePharma's marketing partner in Australia is Shire Pharmaceuticals, who hopes to launch SolarazeR in early 2007 subject to discussions with distributors and approval of product information by the TGA. SkyePharma will receive double digit royalty payments on net sales once marketed.
Frank Condella, SkyePharma ceo, said: 'We are delighted to receive approval from the Australian Therapeutic Goods Administration and look forward to the launch of SolarazeR in Australia next year.'