FDA Approves Taclonex - Once Daily Therapy for Treatment of Psoriasis
ROCKAWAY, N.J., and COPENHAGEN, Denmark, January 10, 2006 -- 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. LEO Pharma submitted the NDA for Taclonex to the FDA in March 2005. Taclonex is a topical ointment containing a combination of calcipotriene 0.005% and betamethasone dipropionate 0.064% for the treatment of psoriasis vulgaris in adults. Taclonex is sold outside the U.S. as Dovobet or Daivobet.
Warner Chilcott acquired the U.S. marketing rights for Dovonex (calcipotriene 0.005%), the leading non-steroidal topical treatment for psoriasis in the U.S., from Bristol-Myers Squibb Company as of January 1. Warner Chilcott is now LEO Pharma's exclusive licensee of Taclonex and Dovonex in the United States. Warner Chilcott expects to launch Taclonex in the first half of 2006.
"Taclonex presents an exciting proposition for the treatment of psoriasis in the U.S., and we are preparing for its launch with great anticipation," said Roger Boissonneault, CEO of Warner Chilcott.
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 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.
Posted: January 2006