Picato® Gel Receives EU Marketing Authorisation for Treatment of Actinic Keratosis (y 2)

        
        - 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 lesions are
          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 least one
          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 keratoses and
          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 is impossible
          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 LEO Pharma

-- Founded in 1908, LEO Pharma is an independent, research-based pharmaceutical company.

-- LEO Pharma develops, manufactures and markets pharmaceutical drugs to dermatologic and thrombotic patients in more than 100 countries globally.

-- The company has its own sales forces in 61 countries and employs around 5,000 people worldwide.

-- LEO Pharma is headquartered in Denmark and is wholly owned by the LEO Foundation.

-- For more information about LEO Pharma, visit http://www.leo-pharma.com.

References

1. Cohen JL. Actinic keratosis treatment as a key component of preventive strategies for nonmelanoma 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 of actinic keratoses and associated factors in a representative sample of the Italian adult population: Results from the Prevalence of Actinic Keratoses Italian Study, 2003-2004. Arch Dermatol. 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 for actinic 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 risk of 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. Apr 2012;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 15 2004;64(8):2833-2839.

11. Ulrich M, Drecoll U, Stockfleth E. Emerging drugs for actinic keratosis. Expert Opin Emerg Drugs. Dec 2010;15(4):545-555.

12. Harvey I, Frankel S, Marks R, Shalom D, Nolan-Farrell M. Non-melanoma skin cancer and solar keratoses. I. Methods and descriptive results of the South Wales Skin Cancer Study. Br J Cancer. Oct 1996;74(8):1302-1307.

13. Memon AA, Tomenson JA, Bothwell J, Friedmann PS. Prevalence of solar damage and actinic keratosis 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 J Med. Apr 24 2003;348(17):1681-1691.

15. Mittelbronn MA, Mullins DL, Ramos-Caro FA, Flowers FP. Frequency of pre-existing actinic keratosis 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 Opin Pharmacother. Dec 2009;10(18):3015-3031.

17. Dodson JM, DeSpain J, Hewett JE, Clark DP. Malignant potential of actinic keratoses and the controversy over treatment. A patient-oriented perspective. Arch Dermatol. Jul 1991;127(7):1029-1031.

18. Salasche SJ. Epidemiology of actinic keratoses and squamous cell carcinoma. J Am Acad Dermatol. Jan 2000;42(1 Pt 2):4-7.

19. Stockfleth E. Topical management of actinic keratosis and field cancerisation. G Ital Dermatol Venereol. Aug 2009;144(4):459-462.

20. Chen GJ, Feldman SR, Williford PM, et al. Clinical diagnosis of actinic keratosis identifies an elderly population at high risk of developing skin cancer. Dermatol Surg. Jan 2005;31(1):43-47.

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CONTACT: Contact: Polly Lutter, Corporate External Relations Manager, LEOPharma, Email: polly.lutter@leo-pharma.com , Tel: +44(0)203-077-0499