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New treatment for solar keratoses now available in New Zealand

Peplin Biotech Tuesday 18 February 2014, 10:34AM

Media release from Peplin Biotech

Picato® (ingenol mebutate) gel, a new innovative topical treatment was launched in New Zealand yesterday. Picato® gel provides a short dosing duration for the treatment of solar keratoses (a very common skin condition).1 Solar keratoses (sometimes referred to as sun spots) often present as rough, scaly patches pre-dominantly on skin frequently exposed to the sun, and can lead to non-melanoma skin cancer if not diagnosed and treated effectively.2,3 There are approximately 67,000 new cases of non-melanoma skin cancers in New Zealand each year.4

Picato® gel is a topical treatment that patients apply once a day for only two or three days, depending on the area of the body being treated.1 Other topical treatments already available can require weeks or even months of therapy, which patients can find difficult to adhere to.5,6,7

Picato® gel works in two ways: firstly it kills sun-damaged cells directly. Secondly, it stimulates the body's own immune system to remove any remaining sun-damaged cells.8

Hon. Assoc. Prof. Amanda Oakley, Waikato Dermatologist and Manager of DermNet New Zealand website, said: "This is great news for New Zealand, where the total number of new melanoma and non-melanoma skin cancer cases amount to around 80% of all new cancers each year.4 If you have solar kera-toses, you have a high risk of developing a type of non-melanoma skin cancer.9"

The availability of Picato® gel was announced at an event yesterday evening in Auckland attended by leading Dermatologists, skin cancer GPs, other health care professionals and key people involved in the 15 year research and development program to bring this new medication to patients who need it. This launch follows approval from the New Zealand regulatory authority (Medsafe) for the treatment of solar keratoses in adults.1

A problem affecting many New Zealanders

Historically New Zealand has one of the highest non-melanoma skin cancer inci-dences in the world.10 More than 90 per cent of skin cancers are due to excessive sun exposure in high UV environments such as New Zealand. UV levels are 40 per cent higher during summer than at corresponding latitudes in the Northern hemisphere. A significant proportion of the population has a fair skin type which burns easily and most New Zealanders have an outdoor lifestyle and a tendency to 'seek the sun'.10,11

Dr Peter Welburn, who was previously Head of R & D for Peplin and whose team developed Picato® is thrilled that this new treatment for actinic keratosis is now being made available to patients in New Zealand. The approval of this product by MedSafe here in New Zealand follows similar approvals in the US, Europe, Canada and Australia.

A New Innovative Treatment

Picato® gel was discovered in Australia. This discovery led to the formation of the Australian company Peplin Biotech, which evaluated the anti-cancer properties of this compound in conjunction with the Queensland Institute of Medical Research (QIMR).

The medication's active ingredient, ingenol mebutate, is derived from the plant Euphorbia peplus, first discovered in 1997 by Australian scientists.

Although Picato® gel is an Australian invention, NZ dermatologists were involved in some important early stage clinical research that was conducted locally.

1. New Zealand Picato® Data Sheet. 11 October 2013.
2. Cohen JL. Actinic kerstoses treatment as a key component of preventive strategies for nonmelanoma skin cancer. J Clin Aesthet Dermatol. Jun 2010;3(6):39-44.
3. Drake LA, Ceilley RI, Cornelison RL, et al. Guidelines of care for actinic keratoses. Committee on Guidelines of Care. J Am Acad Dermatol. Jan 1995;32(1):95-98.
4. http://www.cancernz.org.nz/reducting-your-cancer-risk/sunsmart/about-skin-cancer/skin-cancer-facts-and-figures/ (accessed Dec 2013)
5. Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel for actinic kerstoses. N Engl J Med. Mar 15 2012;366(11):1010-1019.
6. Shoimer I, Rosen N, Muhn C. Current management of actinic keratoses. Skin Therapy Lett. May 2010;15(5):5-7.
7. 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.
8. Berman B. New developments in the treatment of actinic kerstoses: focus on ingenol mebutate gel. Clinical, Cosmetic and Investigational Dermatology. 2012;5(1):111-122
9. Feldman SR, Fleischer AB, Jr. Progression of actinic kerstoses to squamous cell carcinoma revisited: clinical and treatment implications. Cutis; cutaneous medicine for the practitioner. Apr 2011;87(4):201-207.
10. Brougham NDL, Dennett ER, Tan ST. Non-melanoma skin cancers in New Zealand-a neglected problem. NZ Med J. Nov 15 2010;123(1325):59-65.
11. http://www.sciencelearn.org.nz/Contexts/You-Me-and-UV/Looking-Closer/NZ-skin-cancer-statistics (accessed Dec 2013)
12. Stockfleth E, Kerl H. Guidelines for the management of actinic keratoses. Eur J Dermatol. Nov-Dec 2006;16(6):599-606.
13. Criscione VD, Weinstock MA, Naylor MF, Luque C, Eide MJ, Bingham SF. 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.
Full information is available from LEO Pharma Limited, Level 31, Vero Centre, 48 Shortland Street, Auckland 1010 New Zealand or by calling 0800 497 456. Picato, LEO and LEO/lion device are registered trademarks of LEO Pharma A/S, Denmark. © 2014 LNZ-14-001

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