FDA Approves Taclonex Scalp(R) - Once Daily Therapy for Treatment of Moderate to Severe Scalp Psoriasis
May 12 2008 - 8:09AM
PR Newswire (US)
ST. DAVID'S, Bermuda and COPENHAGEN, Denmark, May 12
/PRNewswire-FirstCall/ -- Warner Chilcott and LEO Pharma announced
today 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. DATASOURCE:
Warner Chilcott CONTACT: Rochelle Fuhrmann, Investor Relations,
+1-973-442-3281, Web site: http://www.warnerchilcott.com/
http://www.leo-pharma.com/ http://www.taclonex.com/
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