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LEO Pharma Inc. Receives FDA Approval for Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064% for Body Plaque Psoriasis

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PARSIPPANY, N.J.--(BUSINESS WIRE)--

LEO Pharma Inc., a wholly owned U.S. subsidiary of LEO Pharma A/S, today announced that the U.S. Food and Drug Administration (FDA) approved Taclonex® (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064% for the treatment of body plaque psoriasis. Taclonex® Topical Suspension is a first-line single treatment now indicated for both scalp and body plaque psoriasis for up to 8 weeks.

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. Many patients who have body plaque psoriasis also have psoriasis on their scalp. 2

Taclonex® Topical Suspension is the only once-daily, steroid-containing topical treatment that combines the strength and benefits of 2 active ingredients, a vitamin D analog (calcipotriene) and a corticosteroid (betamethasone dipropionate). Taclonex® Topical Suspension requires only one prescription for both scalp and body treatment of plaque psoriasis. Patients using Taclonex® Topical Suspension may also be eligible to participate in LEO Quality Care™, a patient support program.

“A once-daily application makes Taclonex® Topical Suspension an effective, first-line choice of treatment for a significant number of psoriasis patients, with positive clinical results seen in a recent eight-week study,” said Dr. Alan Menter, founder of the International Psoriasis Foundation. “In addition to its prior approval for use on the scalp, it has been shown to be safe and effective for use on the body.”

In two Phase III clinical studies of more than 1,600 patients with psoriasis on the scalp, and one phase III clinical study of over 1100 patients with psoriasis on the body, a higher percentage of patients treated with Taclonex® Topical Suspension achieved controlled disease than either monotherapies or vehicle used alone. In clinical trials, the most common adverse reactions that occurred in >1% of subjects treated with Taclonex® Topical Suspension and at a rate higher than in subjects treated with vehicle were folliculitis and burning sensation of the skin.

“We are pleased to introduce Taclonex® Topical Suspension as part of our ongoing commitment to helping people achieve healthy skin,” said John Koconis, president and chief executive officer of LEO Pharma Inc. “This most recent FDA approval offers a new, single treatment option for patients suffering from plaque psoriasis on both scalp and body locations, and we look forward to continuously driving patient-centered innovation in the field of dermatology in the years to come.”

INDICATION AND USAGE

Taclonex® Topical Suspension is indicated for the topical treatment of plaque psoriasis of the scalp and body in patients 18 years and older. Apply Taclonex® Topical Suspension to affected areas once daily for up to 8 weeks. Treatment may be discontinued earlier, if cleared. Instruct patients not to exceed a maximum weekly dose of 100 g.

IMPORTANT SAFETY INFORMATION

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.

Hypercalcemia and hypercalciuria have been observed with use of Taclonex® Topical Suspension. If hypercalcemia or hypercalciuria develop, discontinue treatment until parameters of calcium metabolism have normalized. Systemic absorption of topical corticosteroids can produce 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, attempt to withdraw the drug, reduce the frequency of application, or substitute a less potent steroid. Cushing's syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.

In clinical trials, the most common adverse reactions that occurred in ≥1% of subjects treated with Taclonex® Topical Suspension and at a rate higher than in subjects treated with vehicle were folliculitis and burning sensation of the 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 eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria and may be more likely with occlusive use or more potent corticosteroids. Some local adverse reactions may be irreversible.

Taclonex® Topical Suspension may cause eye irritation. Avoid eye exposure. Patients who apply Taclonex® Topical Suspension 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® Topical Suspension 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 have not been studied.

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.

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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

SRPR
Brenda Patterson
440.623.9581
brenda@shevrushpr.com

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