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FDA Approves Picato® (ingenol mebutate) Gel, the First and Only Topical Actinic Keratosis (AK) Therapy With 2 or 3 Consecutive Days of Once-Daily Dosing
Date:1/25/2012

erythema, flaking/scaling, crusting and swelling. 

"LEO Pharma is committed to helping people achieve healthy skin. We are pleased to introduce Picato® gel, a new treatment option for patients with actinic keratosis, a common precancerous condition," said John Koconis, President and CEO, LEO Pharma Inc. "The approval of Picato® gel in the United States is another step forward in helping us realize our vision of becoming a preferred dermatology care partner worldwide."   

For more information about Picato® gel, including full prescribing information, please visit www.leo-pharma.us/home/products/LEO-pharma-products.aspx.

About Actinic Keratosis
Actinic keratosis (AK) is a dry, scaly, rough-textured patch or lesion that forms on the outermost layer of the skin after cumulative exposure to ultraviolet (UV) light, such as sunlight. In some cases, the lesions may be easier to feel than see. The name actinic keratosis literally means "sun-induced rough spot" and therefore the lesions, which can be gray, pink, red or the same color as the skin, are often called sun spots and/or age spots.

A job that requires spending hours of time outside, or everyday activities such as gardening, exercise or attending outdoor sporting events, can lead to sun damage if skin isn't adequately protected. People at high risk are often fair-skinned men and women over the age of 40 who may have accumulated a significant amount of sun exposure over the course of many years.[1]

About Picato® (ingenol mebutate) gel, 0.015%, 0.05%
Picato® gel is indicated for the topical treatment of actinic keratosis.

To date, 18 clinical trials have been completed for the use of Picato® gel, from phase I trials through pivotal phase III trials. In phase III clinical trials, 60-68 percent of patients with actinic k
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SOURCE LEO Pharma Inc.
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