FDA Approves Taclonex Scalp(R) - Once Daily Therapy for Treatment of Moderate to Severe Scalp Psoriasis
12/05/2008 15:56
PR Newswire
ST. DAVID'S, Bermuda and COPENHAGEN, Denmark, May 12 /PRNewswire/ --
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
US$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 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 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.
Web site: http://www.warnerchilcott.com
http://www.leo-pharma.com
http://www.taclonex.com
Rochelle Fuhrmann, Investor Relations, +1-973-442-3281, rfuhrmann@wcrx.com