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New Preclinical Data for Calcipotriol/betamethasone dipropionate (0,005%/0,05%) Foam Presented at American Academy of Dermatology Congress

- BALLERUP, Denmark, March 7, 2016 /PRNewswire/ --

Data presented in a Late Breaking Science session at the 74th Annual Meeting of the American Academy of Dermatology (AAD) in Washington, D.C. demonstrate that calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g) foam formulation is a stable supersaturated solution of the active ingredients, compared to calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g ointment in which the active ingredients are suspended.[ 1] The data presented at AAD showed that no calcipotriol or betamethasone dipropionate crystals were identified in the foam spray following application and for up to 18 hours. However, crystals were present immediately upon application of the ointment formulation. These data may provide a potential explanation for the improved clinical efficacy observed in clinical trials.

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

"We are extremely pleased with the results of this preclinical study, which continue to build our base of evidence to support the efficacy for our product and illustrate why this treatment can make a difference to people living with psoriasis vulgaris," said Gitte Aabo, President and CEO of LEO Pharma. "The data presented at AAD highlight the supersaturation of the product and provide further of evidence of how the product can help patients living with psoriasis vulgaris."

The calcipotriol/betamethasone dipropionate foam has shown increased skin penetration[2] and improved clinical efficacy[3] , [4] compared to the calcipotriol/betamethasone dipropionate ointment. In a Phase II head-to-head clinical trial conducted in 376 subjects with plaque psoriasis, 54.6% of patients using once-daily calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g) foam achieved treatment success as determined by Investigator's Global Assessment at Week 4 compared to 43% of patients using the calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g ointment treatment (p=0.025).[ 4]

"Supersaturation is important for a topical treatment from a dermatological perspective, as it has been shown to improve how effectively a medicine can penetrate the skin," said Dr. Richard Warren, Senior Lecturer and study author. "The results of this study provide a potential explanation that, at least in part, may help us understand why the foam formulation of calcipotriol and betamethasone dipropionate was more effective than the ointment in skin penetration and clinical efficacy."

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.[ 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 type of psoriasis.

[ 7]

Topical treatments are first-line therapies for the majority of patients suffering from psoriasis.[ 7]

About LEO Pharma A/S

LEO Pharma helps people achieve health 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 5,000 people worldwide.

For more information about LEO Pharma, visit http://www.leo-pharma.comSubscribe to our YouTube channel: http://www.youtube.com/leopharmaglobal Follow us on Twitter: https://twitter.com/leohealthyskinVisit us at LinkedIn: http://www.linkedin.com/company/leo-pharma

References

Global Media ContactsJames Freeman Global Communications LEO Pharma A/SJames.Freeman@leo-pharma.comTel: +45-31-66-36-37

7 marzo 2016 ADNKronos
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