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Picato® Gel Receives EU Marketing Authorisation for Treatment of Actinic Keratosis 19.11.2012 - 11:45 Uhr, LEO PharmaBallerup, Denmark (ots/PRNewswire) - Today LEO Pharma announced that the European Commission(EC) has granted marketing authorisation for Picato(R) (ingenol mebutate) gel as a treatmentfor actinic keratosis in the European Union (EU). Picato(R) gel is a once-daily, two orthree day field-directed topical treatment for actinic keratosis, a common skin conditionwhich if not treated can lead to squamous cell carcinoma, a form of non-melanoma skincancer.[1] To view the Multimedia News Release, please click: Actinic keratosis can be an under-diagnosed condition,[2] yet the prevalence in adults agedover 40 years ranges between 11-25 per cent in susceptible populations of the northernhemisphere, and between 40-60 per cent in the southern hemisphere.[3] Current topicaltreatments 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 inBerlin, 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 makesPicato(R) gel a particularly appealing product is the short treatment duration needed totreat actinic keratosis. This short duration - just two or three days - should lead tohigher 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 frequentlyexposed to the sun, such as the face, head, arms and legs. They can occur as single lesionsor multiple lesions affecting an area of skin (a 'field').[7] Actinic keratoses can lead tosquamous cell carcinoma - in fact, research shows 65 per cent of squamous cell carcinomasarise 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 keratosesover a limited area (field) of sun-damaged skin. Picato(R) gel is available in two differentdosage strengths for treatment of specific areas of the body. For treatment of the face andscalp, Picato(R) gel is applied at a concentration of 150 mcg/g once daily for threeconsecutive days. For treatment of the trunk and extremities, the gel is applied at aconcentration 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 recognisetheir symptoms or the significance of them, unaware that lesions can in some cases developinto non-melanoma skin cancer. Picato(R) gel requires just two or three consecutive days oftreatment, compared to several weeks or months for existing topical therapies. Followingapproval in the US, the approval of Picato(R) gel in the EU is another important step in ourgoal 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, bythe Agencia Nacional de Vigilancia Sanitaria (ANVISA) in Brazil in July 2012 and by theTherapeutic Goods Administration (TGA) in Australia in November 2012. - 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 fortwo 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 appliedover 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 onthe 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 skintreated 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) gelshowed a higher treatment satisfaction than placebo-treated patients. Important productinformation - Contact with the eyes should be avoided. Eye disorders such as eye pain, eyelid oedema and periorbital oedema should be expected to occur after accidentaleye 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 iscompromised.
- 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 unlikelyas 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 - Actinic keratoses are skin lesions, which are often red, scaly and may initially be mistaken for a rash or other skin irritation. The majority of lesionsare caused by sun exposure in fair-skinned people.
- The number of patients with actinic keratosis is rapidly growing, especially in Europe, the US and Australia.[11] In the UK, around 3.6 per cent of men aged between 40 and 49 years, and 20 per cent of patients over 60 years, have at leastone actinic keratosis lesion.[12,13] - Actinic keratoses are more common in males, and individuals with a fair skin type. Additional risk factors include advanced age and immunodeficiency.
Immunocompromised patients have a 65 to 250 fold higher risk for actinic keratosesand invasive squamous cell carcinoma.[14] - Actinic keratoses are considered by some to be the earliest stage in the development of non-melanoma skin cancer, with the potential to progress to squamous cell carcinoma, a non-melanoma cancer which is the second most common type of skin cancer.[15,16] - After receiving a diagnosis of actinic keratosis, the risk of developing squamous cell carcinoma over a ten year period is approximately ten per cent for a patient having an average of 7.7 actinic keratosis lesions[16-18] and it isimpossible to predict which lesions will develop into skin cancer.[19] - A study has shown that around 65 per cent of squamous cell carcinoma cases may begin as actinic keratoses[8] and patients with the condition are six times more likely to develop any type of skin cancer than people without it.[20] About LEOPharma - Founded in 1908, LEO Pharma is an independent, research-based pharmaceutical company. - LEO Pharma develops, manufactures and markets pharmaceutical drugs to dermatologic andthrombotic patients in more than 100 countries globally. - The company has its own sales forces in 61 countries and employs around 5,000 peopleworldwide. - LEO Pharma is headquartered in Denmark and is wholly owned by the LEO Foundation. - For more information about LEO Pharma, visit 1. Cohen JL. Actinic keratosis treatment as a key component of preventive strategies fornonmelanoma skin cancer. J Clin Aesthet Dermatol. Jun 2010;3(6):39-44. 2. Naldi L, Chatenoud L, Piccitto R, Colombo P, Placchesi EB, La Vecchia C. Prevalence ofactinic keratoses and associated factors in a representative sample of the Italian adultpopulation: Results from the Prevalence of Actinic Keratoses Italian Study, 2003-2004. ArchDermatol. Jun 2006;142(6):722-726. 3. Frost CA, Green AC. Epidemiology of solar keratoses. Br J Dermatol. Oct 1994;131(4):455-464. 4. Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel foractinic keratosis. N Engl J Med. Mar 15 2012;366(11):1010-1019. 5. Shoimer I, Rosen N, Muhn C. Current management of actinic keratoses. Skin therapy letter.
May 2010;15(5):5-7. 6. Yentzer B, Hick J, Williams L, et al. Adherence to a topical regimen of 5-fluorouracil,0.5%, cream for the treatment of actinic keratoses. Arch Dermatol. Feb 2009;145(2):203-205. 7. Stockfleth E, Kerl H. Guidelines for the management of actinic keratoses. Eur J Dermatol.
Nov-Dec 2006;16(6):599-606. 8. Criscione VD, Weinstock MA, Naylor MF, et al. Actinic keratoses: Natural history and riskof malignant transformation in the Veterans Affairs Topical Tretinoin Chemoprevention Trial.
Cancer. Jun 1 2009;115(11):2523-2530. 9. Cozzi SJ, Ogbourne SM, James C, et al. Ingenol mebutate field-directed treatment of UVB-damaged skin reduces lesion formation and removes mutant p53 patches. J Invest Dermatol. Apr2012;132(4):1263-1271. 10. Ogbourne SM, Suhrbier A, Jones B, et al. Antitumor activity of 3-ingenyl angelate:plasma membrane and mitochondrial disruption and necrotic cell death. Cancer Res. Apr 152004;64(8):2833-2839. 11. Ulrich M, Drecoll U, Stockfleth E. Emerging drugs for actinic keratosis. Expert OpinEmerg Drugs. Dec 2010;15(4):545-555. 12. Harvey I, Frankel S, Marks R, Shalom D, Nolan-Farrell M. Non-melanoma skin cancer andsolar keratoses. I. Methods and descriptive results of the South Wales Skin Cancer Study. BrJ Cancer. Oct 1996;74(8):1302-1307. 13. Memon AA, Tomenson JA, Bothwell J, Friedmann PS. Prevalence of solar damage and actinickeratosis in a Merseyside population. Br J Dermatol. Jun 2000;142(6):1154-1159. 14. Euvrard S, Kanitakis J, Claudy A. Skin cancers after organ transplantation. N Engl JMed. Apr 24 2003;348(17):1681-1691. 15. Mittelbronn MA, Mullins DL, Ramos-Caro FA, Flowers FP. Frequency of pre-existing actinickeratosis in cutaneous squamous cell carcinoma. Int J Dermatol. Sep 1998;37(9):677-681. 16. Berman B, Amini S, Valins W, Block S. Pharmacotherapy of actinic keratosis. Expert OpinPharmacother. Dec 2009;10(18):3015-3031. 17. Dodson JM, DeSpain J, Hewett JE, Clark DP. Malignant potential of actinic keratoses andthe controversy over treatment. A patient-oriented perspective. Arch Dermatol. Jul1991;127(7):1029-1031. 18. Salasche SJ. Epidemiology of actinic keratoses and squamous cell carcinoma. J Am AcadDermatol. Jan 2000;42(1 Pt 2):4-7. 19. Stockfleth E. Topical management of actinic keratosis and field cancerisation. G ItalDermatol Venereol. Aug 2009;144(4):459-462. 20. Chen GJ, Feldman SR, Williford PM, et al. Clinical diagnosis of actinic keratosisidentifies an elderly population at high risk of developing skin cancer. Dermatol Surg. Jan2005;31(1):43-47. Contact: Polly Lutter, Corporate External Relations Manager, LEO Pharma, Email: , Tel: +44(0)203-077-0499

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