LEO Pharma Receives Scientific Approval of Enstilar(R) for the Treatment of Psoriasis in EU

PR63599

BALLERUP, Denmark, Mar. 21, 2016 /PRNewswire=KYODO JBN/--

            The marketing approval of Enstilar(R) would make it the first fixed

combination topical foam treatment for people living with psoriasis vulgaris in

the EU.

    LEO Pharma today announced that it received scientific approval of

Enstilar(R) (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5

mg/g)  for the treatment of psoriasis vulgaris in patients 18 years of age or

older. Enstilar(R) is an alcohol-free foam formulation for the topical

treatment for psoriasis vulgaris.[1]

         (Logo: http://photos.prnewswire.com/prnh/20130221/595427 )

    "The scientific approval of Enstilar(R) is exciting news, not only for LEO

Pharma but also for the millions of Europeans living with psoriasis," said

Gitte Aabo, President and CEO of LEO Pharma. "Enstilar(R) is a

first-of-its-kind topical spray foam and we believe it will help people living

with psoriasis by providing a new type of treatment option that they are

looking for."

    Enstilar(R) was developed to treat patients with psoriasis vulgaris[2],[3]

- the most common clinical form of psoriasis.[4] In Europe, nearly four million

people are living with psoriasis.[5]

    The application in the EU decentralized procedure for Enstilar(R) was based

on the pivotal Phase 3a PSO-FAST study which evaluated the efficacy and safety

profile across a four week period,[5] and the Phase 2 MUSE safety profile

study.[6] In the PSO-FAST clinical trial, over half of patients treated with

Enstilar(R) were "Clear" or "Almost Clear" by Week 4 as measured by the

Investigator Global Assessment (IGA) improvement score.[1] Additionally, more

than half of patients treated with Enstilar(R) achieved a 75% improvement in

Psoriasis Area and Severity Index (PASI) score from baseline.[7]

    The scientific approval means that LEO Pharma has received a positive

outcome of the decentralized procedure.  Receiving this positive outcome is the

final step before national marketing authorisations can be granted by the 30 EU

countries which are part of the procedure.  The national approvals of

Enstilar(R) are expected later this year.  In October 2015, Enstilar(R) was

approved for use by the U.S. Food and Drug Administration (FDA).

    About Enstilar(R)

    Enstilar(R) is a novel topical spray foam treatment for psoriasis that is

designed to provide patients with a convenient treatment option that can be

easily applied. In clinical trials, Enstilar(R) was well-tolerated and provided

fast relief from psoriasis symptoms.  Patients treated with Enstilar(R) in

clinical trials experienced significant improvements in symptoms within the

first week and more than half achieved treatment success after four weeks.

    About Psoriasis

    Psoriasis is a chronic, inflammatory skin disease, which is frequently

accompanied by multiple physical and/or psychological comorbidities, such as

metabolic syndrome and psoriatic arthritis.[6]

    Psoriasis is estimated to affect about 2-4% of the population in western

countries.[8] 80% of patients are affected by psoriasis vulgaris - the most

common type of psoriasis.[4]

    Topical treatments can be used as first-line therapies for the majority of

patients suffering from psoriasis.[4]

    For more information about psoriasis visit our QualityCare[TM] website at:

http://www.qualitycarebyleo.co.uk.

    About LEO Pharma A/S

    LEO Pharma helps people achieve healthy skin. By offering care solutions to

patients in more than 100 countries globally, LEO Pharma supports people in

managing their skin conditions.

    Founded in 1908 and owned by the LEO Foundation, the healthcare company has

devoted decades of research and development to delivering products and

solutions to people with skin conditions.

    LEO Pharma is headquartered in Denmark and employs around 4,800 people

worldwide.

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

    Subscribe to our YouTube channel: http://www.youtube.com/leopharmaglobal

    Follow us on Twitter: https://twitter.com/leohealthyskin

    Visit us at LinkedIn: http://www.linkedin.com/company/leo-pharma

    References

    1.  Enstilar(R) SmPC; 2016

    2.  Hollesen Basse L, et al. Enhanced in vitro skin penetration and

antipsoriatic effect of fixed combination calcipotriol plus betamethasone

dipropionate in an innovative foam vehicle. Journal of Investigative

Dermatology 2014; 134(S30): abstract 192

    3.  Queille-Roussel C, et al. Antipsoriatic effect of a novel aerosol foam

formulation of the fixed combination calcipotriene plus betamethasone

dipropionate in patients with psoriasis, using a modified psoriasis plaque

test. Presented at the Fall Clinical Dermatology Conference, Encore, Las Vegas,

October 16-19, 2014

    4.  Reich K, et al. Efficacy of a fixed combination of with

calcipotriol/betamethasone dipropionate topical gel in adult patients with mild

to moderate psoriasis: blinded interim analysis of a phase IV, multicentre,

randomized, controlled, prospective study. Journal of European Academy of

Dermatology Venereology 2014: October (epub ahead of print) DOI:

10.1111/jdv.12774

    5.  EFPIA Who does psoriasis affect? Available at

http://www.efpia.eu/diseases/134/59/Psoriasis.  Last accessed on February 9,

2016.

    6.  LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris.

2013. ClinicalTrials.gov Identifier: NCT01866163.

    7.  Taraska V, et al. Fixed combination aerosol foam calcipotriene 0.005%

(Cal) plus betamethasone dipropionate 0.064% (BD) exhibits no impact on the HPA

axis and calcium homeostasis in patients with extensive psoriasis vulgaris: a

multicenter, single-arm, Phase II, 4-week MUSE study. Presented at the Skin

Disease Education Foundation's 15th Annual Las Vegas Dermatology Seminar & the

11th Annual SDEF Psoriasis Forum, October 30-November 1, 2014

    8.  Parisi R, et al. Global Epidemiology of Psoriasis: A Systematic Review

of Incidence and Prevalence. The Society for Investigative Dermatology. J

Invest Dermatol 2013;133(2):377-85

     Global Media Contacts

     James Freeman

     Global Patient Communications

     LEO Pharma A/S

     James.Freeman@leo-pharma.com

     Tel: +45-3166-3637

SOURCE: LEO Pharma A/S