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Published on 6 June 2013

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Picato® launched by LEO Pharma

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A new treatment for sun-damaged skin that can lead to skin cancer has been launched  by LEO Pharma.
 
Picato®▼ (ingenol mebutate) gel is a topical treatment licensed for the cutaneous treatment of non- hyperkeratotic, non-hypertrophic actinic keratosis (AK) in adults – which is a type of skin damage caused by long-term sun or UV exposure, that has the potential to progress to the non-melanoma skin cancer, squamous cell carcinoma (SCC).(1,2)
Current topical, patient-applied therapies have treatment durations from three weeks up to three months,(3–7) longer treatment durations can lead to levels of patient adherence as low as 37%.(8)* Picato® effectively manages actinic keratosis with a once-daily treatment, which is applied over two or three days(9) and demonstrates high patient adherence in clinical trials of over 98%.(9)
Actinic keratosis often appears as red, rough, sandpapery patches of skin(10) on areas that are more exposed to sun,(11) such as the face, head, arms and legs. It can occur as a single lesion or multiple lesions affecting an entire area (known as the ‘field’). Where there are multiple lesions, it is important to treat the entire field.(12) Picato® is a field-directed topical gel, indicated for the treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis in adults.(13)
An extensive phase III clinical trial programme has demonstrated that, three days’ treatment application with Picato® 150mcg/g on the face or scalp led to an 83% median reduction in the number of AK lesions compared to baseline, when measured at Day 57.(9) Following two days’ treatment application on the trunk or extremities with Picato® 500mcg/g, there was a 75% median reduction in the number of AK lesions compared to baseline, when measured at Day 57.(9)
Commenting on the launch Rod Tucker, Community Pharmacist and Honorary Research Associate, Faculty of Health and Social Care, University of Hull said, “The launch of Picato® in the UK is a very positive step forward for patients living with actinic keratosis. In England alone 1.6 million people visit a pharmacy each day,(14) which often puts pharmacists in a front line role in advising patients.
 
Pharmacists are also seen as the gateway to the GP and are key to the referral of patients with actinic keratosis. As it is impossible to predict which actinic keratosis lesions will advance to non- melanoma skin cancer offering advice on early detection is very important.”
In March this year, the Scottish Medicines Consortium (SMC) accepted Picato® for use in Scotland (the full advice can be found at the end of this press release).(15) NICE recently published an Evidence Review Summary for ingenol mebutate gel (ESNM14), which recognised that the simple dosing regimen and the short duration of the treatment course compared with other self-applied, field-directed agents (with side effects peaking after treatment is completed) may be beneficial in terms of adherence to treatment.(16)
Dr Stephen Kownacki, Executive Chair of the Primary Care Dermatology Society (PCDS) said, “Actinic keratosis is a condition that in the majority of cases can be managed and treated effectively in primary care, avoiding unnecessary referrals. When treatment is needed, Picato® provides GPs and their patients with an effective and fast treatment to address this potentially pre-cancerous condition.”
Patients are likely to develop local skin responses (LSRs) following treatment with topical therapies for actinic keratosis. The development of LSRs following treatment with Picato® are typically of same day onset, generally predictable over time and typically resolve within two to four weeks depending on body location(9) causing less inconvenience to the daily life of patients.
Rod Tucker added, “Nearly 20% of sales(17) and 12-23%(18) of all consultations are for skin problems – so it is a core part of what we do in pharmacy. 
 
Pharmacists play a pivotal role in medicines management to help patients get the best outcomes from their treatment. For Picato® that means communicating to the patient the importance of storing the treatment in the fridge as well as providing advice on the local skin responses that are common with this type of treatment. Better compliance will result in the ultimate goal of improved outcomes for patients.”
Every year there are more new cases of skin cancer in the UK than breast and lung cancers combined.(19) Worldwide, the number of patients with actinic keratosis is rapidly growing, especially in Europe, the US and Australia. In the UK, approximately one in five patients aged 60+ years have one or more actinic keratoses lesions.(20)
Charlotte Fionda, Director of Skcin, the UK’s only national skin cancer-specific charity, said, “Sadly, public awareness of the dangers of overexposure to UV light is very poor and the incidence of skin cancer and potential precursors such as actinic keratosis is on the rise. It is now more important than ever for the general public to be skin savvy and check their skin for any changes.”
Ingenol mebutate, the active ingredient in Picato® is derived from the sap of the plant Euphorbia peplus (also known as E. peplus). The product has been developed as a new treatment for actinic keratosis following an extensive and complex manufacturing and clinical programme over many years.
Geraldine Murphy, Managing Director of LEO Pharma UK/IE, commented, “LEO Pharma UK/IE is committed to providing total care solutions to people living with skin disease and the launch of Picato® in the UK and Ireland is a significant advance for patients suffering from actinic keratosis. Actinic keratosis can lead to non-melanoma skin cancer and is a growing problem throughout the world. This launch of Picato® in the UK is another step forward towards our goal of helping people achieve healthy skin.”
LEO Pharma is developing a Patient Support Programme to answer questions that patients may have regarding their condition and its treatment. This is called QualityCareTM. A free and confidential nurse supportline for Picato® patients is currently available on Tel: 0800 090 2165. This programme will later include a website for all actinic keratosis patients.
References
  1. Berman B et al. Supplement to: The Journal of Family Practice. May 2006;1-8
  2. Cohen J. J Clin Aesthet Dermatol. 2010; 3:39-44
  3. [SmPC] Meda Pharmaceuticals. Zyclara® (imiquimod) Summary of Product Characteristics Available at www.medicines.org.uk. [Last accessed March 2013]
  4. [SmPC] Almirall. Solaraze® (Diclofenac) Summary of Product Characteristics. Available at www.medicines.org.uk. [Last accessed March 2013]
  5. [SmPC] Almirall. Actikerall® (Fluorouracil/Salicylic Acid) Summary of Product Characteristics. August 2011. Available at www.medicines.org.uk. [Last accessed March 2013]
  6. [SmPC] Meda Pharmaceuticals. Efudix® (Fluorouracil) Summary of Product Characteristics. Available at www.medicines.org.uk. [Last accessed March 2013]
  7. [SmPC] Meda Pharmaceuticals. Aldara® (imiquimod) Summary of Product Characteristics. Available at www.medicines.org.uk. [Last accessed March 2013]
  8. Data on File AK-001 Hamell Market Research. 2012;
  9. Lebwohl M et al. N Eng J Med. 2012; 366:1010-9
  10. Stockfleth E et al. Eur J Dermatol. 2008; 18:651-59
  11. Feldman SR and Fleischer AB, Jr. Cutis. 2011; 87:201-7
  12. Stockfleth E and Kerl H. Eur J Dermatol. 2006; 16:599-606
  13. [SmPC150] LEO Pharma. Picato® 150 mcg/g (ingenol mebutate) gel Summary of Product Characteristics. November 2012. [SmPC500] LEO Pharma. Picato® 500 mcg/g (ingenol mebutate) gel Summary of Product Characteristics. November 2012. Available at www.medicines.org.uk. [Last accessed March 2013]
  14. The Royal Pharmaceutical Society. Available at http://www.rpharms.com/home/about- pharmacy.asp. [Last accessed March 2013]
  15. Scottish Medicines Consortium, March 2013 ingenol mebutate, 150 & 500 micrograms/g, gel (Picato®). SMC No. (851/13). Available at www.scottishmedicines.org.uk.
  16. NICE evidence summary – ESNM14: Actinic keratosis: ingenol mebutate gel. Available at http://publications.nice.org.uk/esnm14-actinic-keratosis-ingenol-mebutate-gel-esnm14.
  17. Smith F and Salkind M. J Soc Adm Pharm 1990; 7:221
  18. Tucker R. In J Pharm Pract. 2012; 20:244
  19. Skin Cancer UK. Skin cancer in the UK: the facts. Available at http://www.skcin.org/Documents/SCUK-DOWNLOAD-VERSION-(1). [Last accessed Dec 2012]
  20. Bonerandi B, Caquant et al. JEADV. 2011; 25:1-51


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