New Data Presented at WCCS Confirm High Long-term Efficacy of Picato(R) in Patients with Actinic Keratosis

PR57763

BALLERUP, Denmark, Sept. 4, 2014 /PRN=KYODO JBN/ --

    - Not for US media

    - The digital press release with multimedia content can be accessed here:

http://www.multivu.com/players/uk/7276254-WCCS-Picato-actinickeratosis/

    New data from the international FIELD Study Repeat presented today at the

15th World Congress of Cancers of the Skin (WCCS) in Edinburgh, Scotland,

demonstrate initial treatment with Picato(R) (ingenol mebutate gel) 0.015% is

efficacious in treating actinic keratoses (AK) and, when followed by a repeat

cycle for persistent and newly emerging AKs, this efficacy is further

increased.[1] The data also confirm two treatment cycles of Picato(R) are well

tolerated by patients.[2]

    These findings are significant as AK is a chronic disease.[1] The presence

of underlying sub-clinical (invisible) lesions can lead to recurrence of

original AKs and the development of new lesions over time[3], which normally

require repeat treatment. The FIELD Study Repeat followed patients over a

one-year-period, confirming both the short and in particular the long-term

benefits when treating once or twice of Picato(R) - with an overall 50%

complete clearance of all AK lesions after one year*.[1]

    Presenting the data at WCCS today, Professor Claus Garbe, Department of

Dermatology, University Hospital Tubingen, Germany and Principal Investigator

of the FIELD Repeat Study, commented: "AK is a very common precursor to

non-melanoma skin cancer, which requires ongoing treatment. The new data from

the FIELD Study Repeat validate Picato(R) as a well-tolerated field-directed

therapy, suitable for the long-term treatment of actinic keratoses, showing an

overall high complete clearance rate after one year."

    The FIELD Study Repeat is part of the larger international FIELD Study

Programme being run by LEO Pharma, designed in partnership with leading

clinicians to investigate the potential broader role of Picato(R) in the

management of AK.

    Additional data from the FIELD Study Programme was recently published in

the Journal of Drugs in Dermatology (JDD)[4] with the long-term results of the

FIELD Study 1, investigating the efficacy of Picato(R) as a field-directed

therapy used sequentially following treatment with cryosurgery.[4]

Results show that combining lesion-specific cryosurgery with Picato(R) field

therapy significantly improves the clearance of AK lesions, with an overall

30.5% complete clearance rate, compared to 18.5% with cryosurgery plus vehicle

gel over a one year period.[4]

    This elevated efficacy results from enhancing the effect of cryosurgery

with Picato(R) on the visible baseline lesions, and from a 'field treatment

effect' of Picato(R) on sub-clinical lesions not visible at baseline

(demonstrated by fewer patients experiencing new lesions when treated with

Picato(R) compared to vehicle gel).[4] The data also confirm Picato(R) field

therapy after cryosurgery is well tolerated.[4]  

    Dr William Hanke, Founder and Medical Director, Dermatologic Surgery, Laser

and Skin Center of Indiana, US, and FIELD Study 1 Principal investigator, added:

"The recently published 12 month data from FIELD Study 1 show sustained patient

benefits of field treatment with Picato(R) in combination with cryosurgery.

These data are now reinforced with evidence that repeat use of Picato(R) is

efficacious and well tolerated over the same time period. Combined, these

studies provide further evidence for the role of field treatment with Picato(R)

in achieving long-term clearance of AK lesions."

    Follow @LEOHealthySkin for the latest updates from #WCCS2014.  

    * Patients treated twice with Picato(R) or treated once and remained clear

at 8w, 26w and 44w, 50% were still clear at 12m (44.0%-56.1%, 95% CI)

    NOTES TO EDITORS

    1. About Picato(R) (ingenol mebutate gel)

    Picato(R) 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 location.[5] Picato(R) has

demonstrated efficacy in clearing actinic keratosis lesions on the face and

scalp, as well as on the trunk and extremities, in a large clinical trial

programme.[5]

Picato(R) 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; by the Therapeutic Goods Administration (TGA) in Australia and the

European Commission (EC) in Europe in November 2012, by Health Canada in

January 2013 and by the Swiss Agency of Therapeutic Products (Swissmedic) in

June 2013.

    2. About FIELD Study Repeat[1]

    The FIELD Study Repeat involved 450 patients across 5 countries globally,

designed to explore the efficacy and tolerability of Picato(R) repeated

treatment within the same area or 'field' on the face or scalp over a 12 month

period. For further information please refer to the

http://www.clinicaltrials.gov website (identifier: NCT01600014).

    3. About the FIELD Study 1[4]

    The FIELD Study 1 involved more than 300 patients across 35 US trial sites

and explored the efficacy and safety profile of sequential treatment of AK on

the face or scalp with cryosurgery followed by Picato(R), 0.015% treatment

compared with cryosurgery followed by vehicle gel. For further information

please refer to the http://www.clinicaltrials.gov website (identifier:

NCT01541553).

    4. About actinic keratosis (AK)

    Actinic keratoses are common skin lesions which are often red and scaly.[6]

The majority of lesions are caused by cumulative sun exposure in fair-skinned

people.[7] AK is a precursor to non-melanoma skin cancer (NMSC).[8] The number

of patients with actinic keratosis is rapidly growing, especially in Europe,

the US and Australia.[9] Prevelance currently ranges from 11-25% in the

Northern Hemisphere to 40-60% in the Southern Hemisphere.[7]

    5. 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 4,800 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.

Watch us on YouTube: http://www.youtube.com/leopharmaglobal.  

    6. Picato(R) Abrev. SmPC  

    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). Picato(R) must not be ingested.

Administration of Picato(R) 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) 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). 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 gel in pregnant women. Risks to humans

receiving cutaneous treatment with ingenol mebutate gel are considered unlikely

as Picato(R) is not absorbed systemically. As a precautionary measure, it is

preferable to avoid the use of Picato(R) during pregnancy. Actinic keratosis is

not a condition generally seen within the paediatric population. The safety and

efficacy of Picato(R) for actinic keratosis in patients less than 18 years of

age have not been established. Please see full prescribing information

available at http://www.leo-pharma.com.

    7. References:

    1. Garbe C. Ingenol mebutate gel 0.015% repeat use for multiple actinic

keratoses on face and scalp: a 12 month pahse 3 clinical study. Presented at

the World Congress on Cancers of the Skin, Edinburgh, Scotland. 4 September 2014

    2. LP0041-22 Clinical Study Report EudraCT no. 2011-005018-13 01-Jul-2014

page 1,165  

    3. Berman B et al. Cutis. 2012; 89:241-50

    4. Berman B et al. Journal of drugs in dermatology : JDD. 2014; 13:741-7

    5. Lebwohl M et al. N Eng J Med. 2012; 366:1010-9

    6. Goldberg L and Mamelak A. Journal of drugs in Dermatology. 2010;

9:1125-32

    7. Frost C et al. The British journal of dermatology. 1994; 142:722-6

    8. Sober A. Cancer. 1995; 75(2 Suppl):645-50

    9. Ulrich M et al. Expert Opinion. 2010; 15:545 - 55

    Global Media Contact  

    Polly Lutter

    Global Communications Manager

    LEO Pharma A/S, Denmark

    polly.lutter@leo-pharma.com

    Tel: +44-(0)20-7300-6137

    http://www.multivu.com/players/uk/7276254-WCCS-Picato-actinickeratosis/

    SOURCE: LEO Pharma