ROCKAWAY, N.J., Oct. 25 /PRNewswire-FirstCall/ -- Researchers reported today that the investigational topical combination therapy calcipotriene/betamethasone dipropionate may provide an effective treatment option for adults suffering from psoriasis. Positive data from three clinical studies were presented during the Fall Clinical Dermatology Conference in Las Vegas, Nevada. Psoriasis is a lifelong skin disease affecting more than 4.5 million adults in the United States.
“Most people diagnosed with psoriasis are candidates for topical therapy,” said Dr. Mark Lebwohl, Chair, Department of Dermatology, Mount Sinai School of Medicine, New York. “There is a need for a more effective topical option that could be used alone or in combination with other treatment strategies.”
Positive results were reported from a 52-week adjudicated safety study of calcipotriene/betamethasone dipropionate in the treatment of 634 adults with psoriasis. In this double-blind study, patients were randomized to one of three treatment groups:
* Calcipotriene/betamethasone dipropionate applied once daily for 52 weeks; * Alternating four-week periods of the two-compound product and calcipotriene ointment alone applied once daily for 52 weeks; or * Four weeks of the two-compound product followed by 48 weeks of calcipotriene ointment alone.
Study findings indicated that there was a smaller proportion of patients with adverse drug reactions of any type in the two-compound group than in the other two treatment arms (21.7% vs 29.6% vs 37.9%, p=<0.001). The incidence of adverse drug reactions associated with long-term use was low (<5%) in all three groups, and no statistically significant differences were found among the groups. The most common adverse events were those related to irritation of the skin.
“These results are particularly meaningful, as they may assuage any concerns regarding long-term use of this product,” said Dr. Lebwohl. “The combination of calcipotriene and betamethasone dipropionate appears to be safe and well-tolerated over an extended period of time.”
The results of two pooled analyses evaluating calcipotriene/betamethasone dipropionate also were presented during the conference. The first analysis examined the efficacy and rapid response of the two-compound ointment previously demonstrated in four large, randomized, controlled Phase 3 clinical studies. Patients who took part in the studies had psoriasis that affected at least 10% of their arms and/or torso and/or legs. Out of a total of 1,534 patients who were treated with the two-compound ointment once daily for four weeks, 81.4% achieved 50% improvement in PASI from baseline (“PASI 50"), which means that this measure of psoriasis severity improved by 50% from the start of the study. Quality-of-life studies show that a 50% improvement in PASI score correlates with the greatest improvement in quality of life for psoriasis patients.
The second pooled analysis examined the efficacy of calcipotriene/betamethasone dipropionate, regardless of disease severity, following four weeks of therapy. A pooled analysis of data from six large, randomized, double-blind, parallel-group, multi-center, multi-national studies involving both once- and twice-daily treatment regimens examined the reduction in PASI scores in patients diagnosed with mild, moderate or severe baseline psoriasis. Also examined were investigators’ assessments of disease severity and patients’ assessments of disease response to treatment.
Findings demonstrated that the two-compound ointment benefited patients in a proportionately similar manner regardless of disease severity. More than 50% of patients with severe disease (PASI scores >17, n=155) judged themselves to be markedly improved or free of disease after four weeks of once-daily treatment. Sixty percent of patients with moderate disease (PASI scores 5-17, n=1,124) and 60% of patients with mild disease (PASI scores <5, n=245) reported the same assessments.
In terms of physician perceptions of treatment success, more than 30% of patients with severe disease (n=119) were considered to have very mild symptoms or absence of disease at the end of the study. Approximately 50% of patients with moderate disease (n=839) and more than 60% with mild disease (n=177) were similarly assessed.
The decrease in patients’ PASI scores at the end of the study was more than 67% in all treatment arms, including a 76.4% reduction among patients with severe disease who were treated once a day and 71.6% treated twice a day.
“The definition of ‘severe’ psoriasis can vary greatly among individuals based on the percentage of body area affected, the location of skin lesions and the psychosocial impact of the disease on a sufferer’s daily life,” said Dr. Lebwohl. “This therapy has demonstrated efficacy regardless of a patient’s disease severity.”
About Calcipotriene/Betamethasone Dipropionate
Calcipotriene/betamethasone dipropionate is a stable, topical combination of calcipotriene, a vitamin D3 analog that helps regulate and inhibit cell growth, and betamethasone dipropionate, 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 63 countries outside of the United States. It is marketed in Europe under the brand name Daivobet(R), and in Canada and the United Kingdom as Dovobet(R).
LEO Pharma submitted a new drug application for calcipotriene/betamethasone dipropionate to the U.S. Food and Drug Administration (FDA) in March 2005. Subject to approval by the FDA, Warner Chilcott expects to initiate marketing of the product in the second quarter of 2006.
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 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. 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.
Psoriasis is an immune-mediated disease that develops when the immune system signals the body to over-react and accelerate the growth of skin cells. Occurring equally in males and females, the disease also carries a genetic component; approximately one-third of people who develop psoriasis have at least one family member with the condition. Signs and symptoms of psoriasis usually appear between 15 and 35 years of age, however, it is possible to develop psoriasis at any age. The earlier the psoriasis appears, the more likely it is to be widespread and recurrent. People often experience flares and remissions throughout their life; controlling the symptoms typically requires lifelong therapy.
For more information, visit the National Psoriasis Foundation website at http://www.psoriasis.org .
About Warner Chilcott
Warner Chilcott is a U.S. specialty pharmaceutical company focused on marketing, developing and manufacturing branded prescription pharmaceutical products in dermatology and women’s healthcare. Read more at http://www.warnerchilcott.com .
About the Fall Clinical Dermatology Conference
The 24th Anniversary Fall Clinical Dermatology Conference(TM) is a four- day program aimed at providing the practicing dermatologist with a comprehensive update on the diagnosis and treatment of a variety of conditions that face dermatologists on a daily basis. The conference is held by the Foundation for Research and Education in Dermatology and is one of the largest annual meetings of dermatologists.
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.
Warner Chilcott
CONTACT: Ginger Hall, 1-800-477-9626 x16, gingerh@mcspr.com, for WarnerChilcott
