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FDA Approves Solaraze (Diclofenac Sodium) Topical Gel For Actinic Keratosis LONDON, UK -- October 23, 2000 -- SkyePharma PLC announced that it has received final approval from the U.S. Food and Drug Administration (FDA) to market its lead dermatology product, Solaraze (diclofenac sodium), for the treatment of actinic keratosis. SkyePharma is currently seeking a North American marketing partner. Solaraze is currently approved for marketing in five member states of the EU (France, Germany, Italy, Sweden, and UK) and has been licensed to Bioglan Pharma Plc for European marketing, manufacturing and distribution. It is also approved in Canada. Solaraze is a topical gel for the treatment of actinic keratosis, a pre-cancerous skin condition caused by over exposure to the sun. Solaraze utilizes SkyePharma's Hyaluronan Induced Targeting transdermal delivery technology. Age, sun exposure and fair skin are risk factors for the development of actinic keratosis which if left untreated may develop into squamous cell carcinoma. The market for actinic keratosis is estimated at US$250 million in the U.S. alone. Approximately 1.3 million people are diagnosed with actinic keratosis annually in the U.S. Michael Ashton, Chief Executive Officer of SkyePharma said, "This approval is an exciting milestone for the Company. We are delighted that the labelling of Solaraze covers all major body areas for the treatment of this pre-cancerous skin condition. This validates the delivery advantages of this technology and as a result we believe that Solaraze will be an important source of revenue commencing in early 2001." SkyePharma PLC, one of the world's leading drug delivery companies, provides innovative services to major pharmaceutical partners from the point of drug discovery through the approval process. Its five technologies, oral, injectable, inhalation, topical, and nanoparticulate solubilization enable SkyePharma to meet 95 percent of the pharmaceutical industry's delivery needs. E-mail this page to a friend or colleague! To print, use this version