LEO Pharma Announces US Regulatory Submission of the First Aerosol Foam for Psoriasis

PR59082

BALLERUP, Denmark, Jan. 6 /PRN=KYODO JBN/ --

    - Not Intended for US Media

    LEO Pharma announced it has submitted a New Drug Application to the US Food

and Drug Administration (FDA) for calcipotriene/betamethasone dipropionate

aerosol foam 0,005%/0,064% for the treatment of psoriasis vulgaris.

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

    The novel aerosol foam formulation of the fixed combination

calcipotriene/betamethasone dipropionate has been developed with the aim of

improving treatment for patients with psoriasis vulgaris[1],[2]- the most

common clinical form of psoriasis.[3]

    The regulatory submission in the US is based on studies of patients with

psoriasis vulgaris. These include the Phase 3a PSO-FAST study which evaluated

efficacy, safety, itch relief and itch-related sleep loss across a four week

period,[4] and the Phase 2 MUSE safety study.[5]

    Kim Kjoller, Senior Vice President, Global Development, commented:

"Psoriasis is a chronic, debilitating disease. Patients with inadequately

managed psoriasis can experience substantial burden of illness, with similar

reductions in quality of life to those experienced by patients with diabetes or

cancer.[5]

    With the regulatory submission announced today, we are taking a step

further in our mission towards reducing this burden by making

calcipotriene/betamethasone dipropionate aerosol foam available for people

living with psoriasis."

    Regulatory filings in Europe and other countries are planned during the

course of 2015 and 2016.

    With this latest submission LEO Pharma reinforces a strong commitment to

dermatology.

    NOTES TO EDITORS

    About Psoriasis

    Psoriasis is a chronic, inflammatory disease, which is frequently

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

metabolic syndrome and psoriatic arthritis.[5]

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

countries.[6] 80% of patients are affected by psoriasis vulgaris - the most

common clinical form of psoriasis.[3]

    Topical treatments are first-line therapies for the majority of patients

since approximately 80% of the patients have mild or moderate psoriasis.[3]

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 visit http://www.leo-pharma.com

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

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

References

    1. 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

    2. 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

    3. 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

    4. LEO 90100 Compared to Vehicle in Subjects With Psoriasis Vulgaris. 2013.

ClinicalTrials.gov Identifier: NCT01866163.

5. 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

    6. 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

    Polly Lutter

    Senior Global Communications Manager

    LEO Pharma A/S, Denmark

    polly.lutter@leo-pharma.com

    Tel: +45-41-37-12-27

    Tony Jackson

    Burson-Marsteller, London

    tony.jackson@bm.com

    Tel: +44-207-400-6370

    SOURCE: LEO Pharma