Warner Chilcott and LEO Pharma announced today that Taclonex® (calcipotriene 0.005% and betamethasone dipropionate 0.064%), a once-daily topical ointment for the treatment of psoriasis vulgaris in adults, is now available for prescription in the United States. Available outside the U.S. as Dovobet® or Daivobet®, Taclonex® was cleared for marketing by the U.S. Food and Drug Administration (FDA) in January. Psoriasis is a lifelong skin disease affecting more than five million adults in the United States.
“The availability of Taclonex® is significant because it makes the treatment of psoriasis easy for patients,” said Dr. Mark Lebwohl, Chair, Department of Dermatology, Mount Sinai School of Medicine, New York. “It only needs to be applied once a day and is rapidly effective. In clinical studies, most patients saw improvement within the first week of use. Additionally, the two-compound ointment is more effective than either of its components alone, and also appears to be more tolerable than the components alone based on a lower percentage of total adverse events reported in clinical studies.”
“At Warner Chilcott, we are continually striving to improve treatment and quality of life for people suffering from diseases of the skin,” said Roger Boissonneault, CEO of Warner Chilcott. “We recognize that psoriasis can be a disabling condition that alters a person’s life, both physically and emotionally, and we are pleased to provide Taclonex® as a new tool in managing its symptoms. Based on the efficacy and rapid action it has demonstrated in clinical studies, we are confident that Taclonex® will be an important new therapy for the topical treatment of psoriasis.”
Taclonex® Clinical Trials
The efficacy and safety of Taclonex® have been demonstrated in seven large, multicenter clinical trials, which enrolled approximately 7,000 psoriasis patients (more than 3,000 of whom were treated with Taclonex®) amenable to topical therapy, with lesions affecting at least 10% of one or more body regions. Patients treated with Taclonex® had significantly greater and more rapid improvement in the Psoriasis Area and Severity Index (PASI) than patients treated with either calcipotriene or betamethasone dipropionate alone. In addition, Taclonex® was safe and well tolerated.
In one randomized, multicenter, double-blind trial, investigators enrolled 1,603 patients to compare the mean change in PASI from baseline to four weeks. They compared Taclonex® with calcipotriene, betamethasone dipropionate, or vehicle (placebo), all used once daily. The study demonstrated that the mean percentage change in PASI from baseline was significantly greater for patients treated with Taclonex® than for those receiving once-daily betamethasone, calcipotriene, or placebo at week 1 (-39.2% vs. -33.3% vs. -23.4% vs. -18.1%, p<0.001) and week 4 (-71.3% vs. -57.2% vs. -46.1% vs. -22.7%, p<0.001), respectively. This study confirmed that Taclonex® used once daily achieved rapid and sustained lesion clearance. In addition, more patients treated with Taclonex® achieved disease control than those treated with either calcipotriene or betamethasone dipropionate alone.
Efficacy Across All Levels of Psoriasis Severity: Pooled Analysis
To determine if Taclonex® was effective in clearing lesions across all levels of psoriasis severity, data were pooled from five double-blind, placebo- and/or active-controlled studies, which randomized 2,661 patients with mild to severe psoriasis to treatment with Taclonex®, calcipotriene, betamethasone dipropionate, or vehicle (placebo). Patients were grouped according to baseline severity. All treatments were applied once daily to lesions on the trunk or limbs over four weeks. The results of the analysis showed that Taclonex® applied once daily had a faster onset of action and a greater reduction in mean percent PASI from baseline, regardless of disease severity (38-41% reduction in PASI at the end of week 1, 55-60% at the end of week 2, and 68-72% at the end of week 4).
About Taclonex®
Taclonex® is a stable, topical combination of calcipotriene 0.005%, a vitamin D3 analog that helps regulate and inhibit cell growth, and betamethasone dipropionate 0.064%, a potent corticosteroid that helps manage inflammation. Developer LEO Pharma A/S of Ballerup, Denmark has partnered with Warner Chilcott to commercialize the product in the United States. The product is already available in more than 60 countries outside of the United States. It is marketed in Europe under the brand name Daivobet®, and in Canada and the United Kingdom as Dovobet®.
Taclonex® is now available by prescription in pharmacies throughout the U.S.
Important Safety Information about Taclonex® Ointment
Taclonex® Ointment is indicated for the topical treatment of psoriasis vulgaris in adults 18 years of age and above for up to 4 weeks.
FOR EXTERNAL USE ONLY. Should not be applied to the face, axillae or groin.
Taclonex® Ointment should not be used in patients with hypersensitivity to any of its components; known or suspected disorders of calcium metabolism; or erythrodermic, exfoliative or pustular psoriasis.
Systemic absorption of products containing topical corticosteroids, including Taclonex® Ointment, has produced reversible hypothalamic- pituitary-adrenal (HPA) axis suppression.
In clinical trials, the most frequent side effects were pruritus, scaly rash and worsening of psoriasis.
For further information on the safety and use of Taclonex, please see the full prescribing information for Taclonex available at www.taclonex.com.
About Psoriasis
Psoriasis is a chronic, inflammatory skin disease for which there is no cure. In plaque psoriasis, 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. According to the National Psoriasis Foundation, close to five million adults in the United States have psoriasis, and up to 260,000 are diagnosed every year.
About Warner Chilcott
Warner Chilcott is a specialty pharmaceutical company focused on marketing, developing and manufacturing branded prescription pharmaceutical products in dermatology and women’s healthcare in the United States. Read more on www.warnerchilcott.com.
About LEO Pharma
LEO Pharma is a research based pharmaceutical company employing 3,000 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. For a discussion of these risks and uncertainties, see our quarterly reports to the holders of the 8-3/4% Senior Subordinated Notes due 2015 (the “Notes”) issued by the Company’s affiliate, Warner Chilcott Corporation. These documents and other information are available upon request at no cost, by sending a request by email to bkozinski@wcrx.com or by mail to 100 Enterprise Drive, Rockaway, New Jersey, 07866, Attention: Beth Kozinski.
CONTACTS: Warner Chilcott Paul Herendeen Tel: +1 973-442-3200 Executive Vice President pherendeen@wcrx.com And Chief Financial Officer
LEO Pharma Adam Estrup Tel: +45 72 26 23 53 Director, Corporate Communications adam.estrup@leo-pharma.com
MCS Public Relations Tel: +1 908-234-9900 Ginger Hall, Vice President gingerh@mcspr.com
Source: Warner Chilcott
