LEO Pharma Inc. Announced New Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064% Indication for Treatment of Scalp Plaque Psoriasis in Pediatric Patients Ages 12-17

LEO Pharma Inc. Announced New Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064% Indication for Treatment of Scalp Plaque Psoriasis in Pediatric Patients Ages 12-17

First Approved Combination Topical Treatment for Scalp Plaque Psoriasis in Adolescent Patients

Parsippany, NJ — September 30, 2014  — LEO Pharma Inc., a wholly owned U.S. subsidiary of LEO Pharma A/S, today announced a new Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension indication for a topical combination treatment of plaque psoriasis of the scalp in patients 12 to 17 years – the first indication for adolescent patients aged 12 years and older with scalp plaque psoriasis on the market.
Taclonex® Topical Suspension is a first-line, once-daily combination product indicated for treatment of both scalp and body plaque psoriasis in adults age 18 and above for up to eight weeks, and now for the treatment of plaque psoriasis of the scalp in pediatric patients 12 to 17 years for the same period.

"At LEO, our goal is to help people achieve healthy skin," said Jorgen Damsbo Andersen, chief executive officer of LEO Pharma Inc. "With this new indication, we're able to help younger people with scalp plaque psoriasis who until now have not had access to Taclonex® Topical Suspension."
Psoriasis is a non-contagious, chronic disease of the immune system that affects an estimated 125 million people worldwide.1 The most common form, which affects roughly 80 percent of people who have the condition, is plaque psoriasis (psoriasis vulgaris). It is characterized by patches of raised, reddish skin covered with silvery-white scales.2 The exact prevalence in children is not known; however, approximately one-third of people with psoriasis are first diagnosed before age 20.3

"I am thrilled that we now have an FDA-approved therapy for plaque psoriasis of the scalp for adolescent patients," says Dr. Kelly Cordoro, M.D., Associate Professor of Dermatology and Pediatrics, University of California, San Francisco. "The scalp is a very common site of involvement in this age group and can be extremely difficult to manage.  Taclonex offers the strength of a potent topical steroid along with the added efficacy of combining it with calcipotriene. One product, applied once daily is ideal for adolescent patients for whom lack of adherence to complex regimens represents a significant barrier to gaining control of the disease."

The dual action of a corticosteroid (betamethasone dipropionate) and vitamin D analog (calcipotriene) in Taclonex® Topical Suspension provides enhanced efficacy and may reduce side effects as compared to either agent used alone.4 It is the only once-daily, topical treatment that combines these two active ingredients, requiring a single prescription for treatment of both scalp and body plaque psoriasis in adults and now for scalp plaque psoriasis in adolescents.

Dr. Jerry Bagel, M.D., Psoriasis Treatment Center of Central New Jersey, adds: "The psychological burden resulting in loss of self esteem from scalp psoriasis is especially devastating in the adolescent. The new indication for Taclonex in the treatment of scalp psoriasis in patients over the age of 12 offers the adolescent not only an effective therapy to combat the appearance of psoriasis, but can help them regain their self-esteem and self confidence which may transcend a lifetime."

For more information about the new indication, visit http://www.taclonex.com.

Taclonex® Topical Suspension is indicated for the topical treatment of plaque psoriasis of the scalp and body in patients 18 years and older and for plaque psoriasis of the scalp in patients 12 to 17 years. Apply Taclonex® Topical Suspension to affected areas once daily for up to 8 weeks. Therapy should be discontinued when control is achieved. Patients 18 years and older should not use more than 100 g per week and patients 12 to 17 years should not use more than 60 g per week.

FOR TOPICAL USE ONLY. Taclonex® Topical Suspension is not for oral, ophthalmic, or intravaginal use and should not be applied to the face, axillae, or groin.  Do not use if atrophy is present at the treatment site. Do not use with occlusive dressings unless directed by a physician.

Hypercalcemia and hypercalciuria have been observed with use of Taclonex®. If hypercalcemia or hypercalciuria develop, discontinue treatment until parameters of calcium metabolism have normalized. Taclonex® can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. Use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression and calcium abnormalities. If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent steroid. Cushing's syndrome and hyperglycemia may also occur in adults due to the systemic effects of the topical corticosteroid. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity, HPA axis suppression and adrenal insufficiency. Rare systemic toxicities such as Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients.

In clinical trials, the most common adverse reactions that occurred in >1% of subjects treated with Taclonex® and at a rate higher than in subjects treated with vehicle were folliculitis and burning sensation of skin.  Other less common adverse reactions (<1% but >0.1%) were, in decreasing order of incidence: acne, exacerbation of psoriasis, eye irritation, and pustular rash. Local adverse reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform dermatitis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria and may be more likely with occlusive use or more potent corticosteroids.

Taclonex® may cause eye irritation. Avoid eye exposures. Patients who apply Taclonex® to exposed skin should avoid excessive exposure to either natural or artificial sunlight, including tanning booths, sun lamps, etc. There are no adequate and well-controlled studies of Taclonex® Topical Suspension in pregnant women. Taclonex® should be used during pregnancy only if the potential benefit to the patient justifies the potential risk to the fetus. Because many drugs are excreted in human milk, caution should be exercised when Taclonex® Topical Suspension is administered to a nursing woman. The patient should be instructed not to use Taclonex® Topical Suspension on the breast when nursing. Safety and effectiveness of the use of Taclonex® Topical Suspension in pediatric patients under the age of 12 years have not been established.

For full prescribing information, visit www.taclonex.com

About LEO Pharma Inc.
LEO Pharma Inc. is a wholly owned subsidiary of LEO Pharma A/S. Founded in 1908, LEO Pharma A/S is an independent, research-based pharmaceutical company. LEO Pharma A/S develops, manufactures and markets pharmaceutical drugs in more than 100 countries globally. The company has its own sales forces in 61 countries and employs more than 4,600 employees worldwide. LEO Pharma A/S is headquartered in Denmark and is wholly owned by the LEO Foundation.

1  "Facts About Psoriasis" Psoriasis.org. National Psoriasis Foundation. Accessed October 5, 2012. http://www.psoriasis.org/document.doc?id=1492

2  "Psoriasis" AAD.org. American Academy of Dermatology. Accessed October 5, 2012.  http://www.aad.org/media-resources/stats-and-facts/conditions/psoriasis/psoriasis

3 National Psoriasis Foundation Psoriasis and Children Issue Brief Executive Summary January 2012

4 Segaert S, Ropke M. The biological rationale for use of vitamin D analogs in combination with corticosteroids for the topical treatment of plaque psoriasis. J Drugs Dermatol. 2013;12(8);e129-e137.

LEO, the LEO Lion Design and Taclonex are registered trademarks of LEO Pharma A/S.
Copyright 2014 LEO Pharma Inc.        3428-TS-14-123          September 2014          Printed in USA

Kristi Lane
srpr |  shev rush public relations
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