Warner Chilcott and LEO Pharma Announce NDA Submission for Taclonex Scalp(R) Gel
HAMILTON, Bermuda, and COPENHAGEN, Denmark, June 29 /PRNewswire-FirstCall/ -- Warner Chilcott and LEO Pharma announced today that LEO Pharma has submitted a New Drug Application for Taclonex Scalp(R) gel to the U.S. Food and Drug Administration. Taclonex Scalp(R) gel is a topical gel for the treatment of scalp psoriasis vulgaris in adults. Taclonex Scalp(R) gel contains the same active ingredients as Taclonex(R) ointment (a combination of calcipotriene 0.005% and betamethasone dipropionate 0.064%).
More than 4.5 million adults in the United States have been diagnosed with psoriasis, and approximately 150,000 new cases are diagnosed each year. According to the National Psoriasis Foundation, at least half of all people diagnosed with psoriasis have it on their scalp.
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 scale. 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.
Warner Chilcott is LEO Pharma's exclusive licensee of Taclonex Scalp(R) gel, Taclonex(R) ointment and Dovonex(R) in the United States.
Warner Chilcott Warner Chilcott is a leading specialty pharmaceutical company focused on developing, manufacturing, marketing and selling branded prescription products in the women's healthcare and dermatology therapeutic categories in the United States. WCRX-G
Read more on www.warnerchilcott.com.
LEO Pharma is a research based pharmaceutical company employing 3,300 people in more than 40 countries. Headquartered in Denmark, LEO Pharma is among the world's leading companies in topical dermatology and parenteral treatment of thromboembolic disorders.
Read more on 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; 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; an increase in litigation, including product liability claims and patent litigation; 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 business; our ability to manage the growth of our business by successfully identifying, developing, acquiring or licensing and marketing new products, obtain regulatory approval and customer acceptance of those products, and continued customer acceptance of our existing products; the other risks identified in our December 31, 2006 annual report on Form 10-K; and other risks detailed from time-to-time in our 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
CONTACT: Investors, Rochelle Fuhrmann of Warner Chilcott, +1-973-442-3281,rfuhrmann@wcrx.com; or Dag Holmstad, Director, Corporate Communication ofLEO Pharma, +45-72-26-23-53, dag.holmstad@leo-pharma.com