Picato® Gel Receives EU Marketing Authorisation for Treatment of Actinic Keratosis (1)

BALLERUP, Denmark, November 19, 2012 /PRNewswire/ --

Today LEO Pharma announced that the European Commission (EC) has granted marketing authorisation for Picato(R) (ingenol mebutate) gel as a treatment for actinic keratosis in the European Union (EU). Picato(R) gel is a once-daily, two or three day field-directed topical treatment for actinic keratosis, a common skin condition which if not treated can lead to squamous cell carcinoma, a form of non-melanoma skin cancer.[1]

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Actinic keratosis can be an under-diagnosed condition,[2] yet the prevalence in adults aged over 40 years ranges between 11-25 per cent in susceptible populations of the northern hemisphere, and between 40-60 per cent in the southern hemisphere.[3] Current topical treatments have long treatment durations that last for periods from one, up to four months, which can lead to low patient adherence.[4-6]

Professor Eggert Stockfleth, Head of Dermatology at the Skin Centre Charite Hospital in Berlin, Germany and Head of the European Skin Cancer Foundation (ESCF), commented:

"Since it is impossible to predict which actinic keratosis lesions will advance to non-melanoma skin cancer, early detection and effective treatment is critical. What makes Picato(R) gel a particularly appealing product is the short treatment duration needed to treat actinic keratosis. This short duration - just two or three days - should lead to higher patient adherence. In clinical trials adherence was as high as 98 per cent."

Actinic keratoses often appear as red, scaly lesions predominantly seen on skin frequently exposed to the sun, such as the face, head, arms and legs. They can occur as single lesions or multiple lesions affecting an area of skin (a 'field').[7] Actinic keratoses can lead to squamous cell carcinoma - in fact, research shows 65 per cent of squamous cell carcinomas arise from lesions previously diagnosed as actinic keratoses.[8]

Picato(R) gel is indicated for the cutaneous treatment of adult patients with non-hyperkeratotic, non-hypertrophic actinic keratosis. Picato(R) gel treats actinic keratoses over a limited area (field) of sun-damaged skin. Picato(R) gel is available in two different dosage strengths for treatment of specific areas of the body. For treatment of the face and scalp, Picato(R) gel is applied at a concentration of 150 mcg/g once daily for three consecutive days. For treatment of the trunk and extremities, the gel is applied at a concentration of 500 mcg/g once daily for two consecutive days.

Gitte P. Aabo, Chief Executive Officer (CEO) of LEO Pharma, commented:

"Actinic keratosis is a growing problem across the world, yet many patients do not recognise their symptoms or the significance of them, unaware that lesions can in some cases develop into non-melanoma skin cancer. Picato(R) gel requires just two or three consecutive days of treatment, compared to several weeks or months for existing topical therapies. Following approval in the US, the approval of Picato(R) gel in the EU is another important step in our goal of helping people across the world achieve healthy skin."

Picato(R) gel was approved by the US Food and Drug Administration (FDA) in January 2012, by the Agencia Nacional de Vigilancia Sanitaria (ANVISA) in Brazil in July 2012 and by the Therapeutic Goods Administration (TGA) in Australia in November 2012.

About Picato(R) gel

        
        - Picato(R) gel is a topical, field-directed therapy which is
          self-administered by the patient to the affected areas of the skin once a day for two
          or three consecutive days, depending on the treatment area.
        - Picato(R) gel has two strengths and two application regimens to follow,
          dependent upon the location of the actinic keratoses. Picato(R) gel is applied over a
          25cm2 treatment area for two consecutive days when treating actinic keratoses on the
          trunk and extremities (500 mcg/g) and over three consecutive days for the face and
          scalp (150mcg/g).
        - Picato(R) gel has been shown in a large clinical trial programme to
          effectively clear actinic keratosis lesions on the face and scalp, as well as on the
          trunk and extremities.[4]
        - The mechanism of action (MoA) for Picato(R) gel is not fully understood. In
          vivo and in vitro data suggest a dual MoA, including direct lesional cell death and
          infiltration of immunocompetent cells.[9,10] Non-invasive examination of skin treated
          with Picato(R) gel showed an almost complete resolution of induced skin changes
          measured at two months post treatment, and patients treated with Picato(R) gel showed
          a higher treatment satisfaction than placebo-treated patients.

Important product information

        
        - Contact with the eyes should be avoided. Eye disorders such as eye pain,
          eyelid oedema and periorbital oedema should be expected to occur after accidental eye
          exposure of Picato(R) gel.
        - Picato(R) gel must not be ingested.
        - Administration of Picato(R) gel is not recommended until the skin is healed
          from treatment with any previous medicinal product or surgical treatment and should
          not be applied to open wounds or damaged skin where the skin barrier is compromised.
        - Picato(R) gel should not be used near the eyes, on the inside of the nostrils,
          on the inside of the ears or on the lips.
        - Local skin responses such as erythema, flaking/scaling, and crusting should be
          expected to occur after cutaneous application of Picato(R) gel.
        - Due to the nature of the disease, excessive exposure to sunlight (including
          sunlamps and tanning beds) should be avoided or minimised.
        - Lesions clinically atypical for actinic keratosis or suspicious for malignancy
          should be biopsied to determine appropriate treatment.
        - There are no data from the use of ingenol mebutate in pregnant women. Risks to
          humans receiving cutaneous treatment with ingenol mebutate are considered unlikely as
          Picato(R) gel is not absorbed systemically. As a precautionary measure, it is
          preferable to avoid the use of Picato(R) gel during pregnancy.
        - There is no relevant use of Picato(R) gel in the paediatric population.
        - Please see full prescribing information available at
          http://www.leo-pharma.com.

About actinic keratoses

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