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FDA Approves Taclonex Scalp®


- Once Daily Therapy for Treatment of Moderate to Severe Scalp Psoriasis

Warner Chilcott and LEO Pharma announced that the United States Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Taclonex Scalp® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension.

LEO Pharma submitted the NDA for Taclonex Scalp® to the FDA in July 2007. Taclonex Scalp® is a topical suspension containing a combination of calcipotriene 0.005% and betamethasone dipropionate 0.064% for the treatment of moderate to severe psoriasis vulgaris of the scalp in adults. Taclonex Scalp® is called Xamiol® outside the United States.

“Taclonex Scalp® represents an exciting addition to our Taclonex® and Dovonex® franchise, expanding the treatment options for psoriasis patients in the U.S.,” said Roger Boissonneault, CEO of Warner Chilcott Limited.

US launch 2008

Warner Chilcott is LEO Pharma’s exclusive licensee of Taclonex® and Dovonex® products in the United States. Warner Chilcott expects to launch Taclonex Scalp® in the second half of 2008.

As a result of the FDA approval of Taclonex Scalp®, Warner Chilcott will pay a milestone payment of $40 million to LEO Pharma in June 2008. Warner Chilcott will record the milestone payment as an intangible asset on its balance sheet and will amortize it over the useful life of the product.

Scalp psoriasis

Psoriasis is a chronic, inflammatory skin disease for which there is no cure. In plaque psoriasis (psoriasis vulgaris), the most common type, patches of skin called “lesions” become inflamed and are covered by silvery white scales. A non-contagious disorder, psoriasis can occur on any part of the body, and can significantly alter a sufferer’s life both physically and mentally, including the ability to work, play and interact with others.

Scalp psoriasis is very common. In fact, at least half of all people who have psoriasis have it on their scalp. As with psoriasis elsewhere on the body, skin cells grow too quickly on the scalp and cause red lesions covered with scales to appear. As many as 7.5 million Americans have been diagnosed with psoriasis.


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