FDA Approves Taclonex Scalp(R) Once Daily Therapy For Treatment Of Moderate To Severe Scalp Psoriasis

Main Category: Eczema / Psoriasis
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 14 May 2008 - 0:00 PDT

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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(R) (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension. LEO Pharma submitted the NDA for Taclonex Scalp(R) to the FDA in July 2007. Taclonex Scalp(R) 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(R) is called Xamiol(R) outside the United States.

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

Warner Chilcott is LEO Pharma's exclusive licensee of Taclonex(R) and Dovonex(R) products in the United States. Warner Chilcott expects to launch Taclonex Scalp(R) in the second half of 2008. As a result of the FDA approval of Taclonex Scalp(R), 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.

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.

About Warner Chilcott

Warner Chilcott is a leading specialty pharmaceutical company currently focused on the Women's Healthcare and Dermatology segments of the U.S. pharmaceuticals market. It is a fully integrated company with internal resources dedicated to the development, manufacturing and promotion of its products. WCRX-G

Read more on http://www.warnerchilcott.com.

About LEO Pharma

LEO Pharma is a research based pharmaceutical company with headquarters in Denmark and 100% owned by the LEO Foundation. LEO Pharma is a global leading company within topical dermatology and parenteral treatment of thromboembolic disorders and employing about 3,000 people in more than 40 countries.

Read more on http://www.leo-pharma.com.

Warner Chilcott's Forward Looking Statements:

This press release contains forward-looking statements, including statements concerning our operations, our economic performance and financial condition, and our business plans and growth strategy and product development efforts. These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words "may," "might," "will," "should," "estimate," "project," "plan," "anticipate," "expect," "intend," "outlook," "believe" and other similar expressions are intended to identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of their dates. These forward-looking statements are based on estimates and assumptions by our management that, although we believe to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties.

The following represent some, but not necessarily all, of the factors that could cause actual results to differ from historical results or those anticipated or predicted by our forward-looking statements: our substantial indebtedness; competitive factors in the industry in which we operate (including the approval and introduction of generic or branded products that compete with our products); our ability to protect our intellectual property; a delay in qualifying our manufacturing facility to produce our products or production or regulatory problems with either third party manufacturers upon whom we may rely for some of our products or our own manufacturing facility; pricing pressures from reimbursement policies of private managed care organizations and other third party payors, government sponsored health systems, the continued consolidation of the distribution network through which we sell our products, including wholesale drug distributors and the growth of large retail drug store chains; the loss of key senior management or scientific staff; adverse outcomes in our outstanding litigation or an increase in the number of litigation matters to which we are subject; government regulation affecting the development, manufacture, marketing and sale of pharmaceutical products, including our ability and the ability of companies with whom we do business to obtain necessary regulatory approvals; our ability to manage the growth of our business by successfully identifying, developing, acquiring or licensing new products at favorable prices and marketing such new products; our ability to obtain regulatory approval and customer acceptance of new products, and continued customer acceptance of our existing products; changes in tax laws or interpretations that could increase our consolidated tax liabilities; the other risks identified in our Annual Report on Form 10-K for the year ended December 31, 2007; and other risks detailed from time-to-time in our public filings, financial statements and other investor communications.

We caution you that the foregoing list of important factors is not exclusive. In addition, in light of these risks and uncertainties, the matters referred to in our forward-looking statements may not occur. We undertake no obligation to publicly update or revise any forward-looking statement as a result of new information, future events or otherwise, except as may be required by law.

Warner Chilcott
http://www.warnerchilcott.com