HAMILTON, Bermuda, and COPENHAGEN, Denmark, June 29 /PRNewswire/ --
Warner Chilcott (Nasdaq: WCRX) 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.
Web site: http://www.warnerchilcott.com
http://www.leo-pharma.com
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