Navigation Links
FDA Approves Taclonex Scalp(R) - Once Daily Therapy for Treatment of Moderate to Severe Scalp Psoriasis

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


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.


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.

SOURCE Warner Chilcott
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. FDA Approves Health Claim for Brown Rice
2. FDA Approves Strattera(R) for Maintenance of ADHD in Children and Adolescents
3. FDA approves HeartMate II mechanical heart pump for heart-failure patients
4. FDA Approves Advair(R) 250/50 for Reduction of Exacerbations in Patients With COPD
5. FDA Approves New Once-a-Month Dose of Actonel for Postmenopausal Osteoporosis
6. FDA approves VYVANSE, first and only once-daily prodrug stimulant to treat ADHD in adults
8. House Overwhelmingly Approves Renewal and Tripling of Successful U.S. Global AIDS Prevention Effort
9. VeriPrime Approves New Best Practices for Beef Production
10. U.S. EPA Approves Registration of Antimicrobial Copper Alloys
11. Arizona Senate Approves Smoking Cessation Treatments for State Medicaid Beneficiaries
Post Your Comments:
(Date:10/13/2015)... ... October 13, 2015 , ... ... private messaging application, announced today a significant contract that will provide its award-winning ... plans to build on the growing success of its Relay program, IBX Wire™, ...
(Date:10/13/2015)... ... 13, 2015 , ... e-con Systems Inc., a leading embedded design services company ... industry’s first RGB-IR pixel format camera with a USB 3.0 interface and e-CAM40_CUMI4682_MOD, ... of UVC USB 3.0 cameras, is based on the 1/3-inch OV4682 - a 4-megapixel ...
(Date:10/13/2015)... , ... October 13, 2015 , ... A child without ... why SmileCareClub , the leading remote invisible aligner system, has joined with ... otherwise go without it. For each aligner treatment plan purchased, SmileCareClub will donate one ...
(Date:10/13/2015)... (PRWEB) , ... October 13, 2015 , ... Protein is ... the body, including muscle, bone, and blood. But how much protein does the average ... than it might seem, according to the October 2015 issue of Harvard Men's ...
(Date:10/13/2015)... ... October 13, 2015 , ... ... targets the unique health needs of new moms. Postnatal Omega-3, which has ... ), utilizes Nordic Naturals’ exclusive, new, ultra-concentrated omega-3 oil. This breakthrough ...
Breaking Medicine News(10 mins):
(Date:10/13/2015)... LA JOLLA, Calif. , Oct. 13, 2015 /PRNewswire/ ... to revolutionize the practice of medicine, announced today the ... powered clinical research project that has the potential to ... San Diego, CA , at HLI,s ... open in 2016 in other US and International cities. ...
(Date:10/13/2015)... PARK, Calif. , Oct. 13, 2015 /PRNewswire/ ... of up to $100 million over five years ... Diseases (NIAID), part of the National Institutes of ... or treat acute or delayed effects of radiation ... , a division of SRI International will provide ...
(Date:10/13/2015)... MILFORD, Mass. , Oct. 13, 2015  SeraCare ... diagnostics manufacturers, announced today that the company,s precision medicine ... growing line of reference materials for next-generation sequencing (NGS)-based ... Mutation Mix-I (AF1-10) contains the same mixture of mutations ... the previously launched AF20 mix , but is ...
Breaking Medicine Technology: