LEO Pharma Announces That Picato® gel has Been Approved by US FDA for Once-Daily, 2 or 3 day Treatment of Actinic Keratoses

LEO Pharma today announced that Picato® (ingenol mebutate) gel (0.015%, 0.05%) has been approved by the US Food and Drug Administration (FDA) as a treatment for actinic keratoses (AK) on the face, scalp, trunk and extremities. Picato® gel is a once-daily, field-directed topical treatment for AK, a potential precursor to non-melanoma skin cancer caused by cumulative sun exposure. Treatment with Picato® gel is completed over two consecutive days for AK on the trunk and extremities and over three consecutive days on the face and scalp.

Commenting on today's announcement, Mark Lebwohl, M.D, Professor and Chair, Department of Dermatology, Mount Sinai Medical Center in New York, said,"Since there is no way to predict which actinic keratoses will advance to skin cancer, early detection and treatment of lesions are critical. What makes this new therapy particularly exciting is the two or three day course of treatment."

Gitte P. Aabo, Chief Executive Officer of LEO Pharma, said, "Actinic keratoses affect millions of people, but many are not aware that they have the condition or that in some cases it can lead to skin cancer.Picato® gel requires just two or three consecutive days of treatment, compared to several weeks or months for existing topical therapies. We believe this shorter duration of treatment will be well received by both patients and clinicians. The approval of Picato® gel is another important step in LEO Pharma's goal of becoming one of the world's leading dermatology companies."

LEO Pharma expects Picato® to be available to US physicians in March 2012.

 

For further information, please contact
Helga Heyn
Corporate External Relations Manager
Tel.: +44(0)207-269-9364
E-mail: helga.heyn@leo-pharma.com

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