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

Ballerup, Denmark (ots/PRNewswire) -

- 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 Kjøller, 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 thisburden 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

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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

Photo:
http://photos.prnewswire.com/prnh/20130221/595427

ots Originaltext: LEO Pharma
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