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

Ballerup, Denmark (ots/PRNewswire) -

Not for US media

The digital press release with multimedia content can be accessed
here: http://www.multivu.com/players/uk/7276254-WCCS-Picato-actinicke
ratosis

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 Tübingen, 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 Agência Nacional de Vigilância
Sanitária (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

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

ots Originaltext: LEO Pharma
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