Warner Chilcott (ST. DAVID'S, Bermuda) and LEO Pharma (COPENHAGEN, Denmark) announced that the US FDA has approved the new drug application (NDA) for Taclonex Scalp^® (calcipotriene 0.005% and betamethasone dipropionate 0.064%) topical suspension for the treatment of moderate-to-severe psoriasis vulgaris of the scalp in adults. LEO Pharma submitted the NDA for Taclonex Scalp to the FDA in July 2007. Taclonex Scalp is marketed as Xamiol^® outside the US.

Warner Chilcott, a leading specialty pharmaceutical company currently focused on the women's healthcare and dermatology segments of the US pharmaceuticals market, is LEO's exclusive licensee of Taclonex and Dovonex^® products in the US. Warner expects to launch Taclonex Scalp in the second half of 2008. As a result of the FDA approval of Taclonex Scalp, Warner will pay a milestone payment of $40 million to LEO in June 2008. At least half of all people who have psoriasis have it on their scalp.

In January 2006, the US FDA approved Taclonex once-daily topical ointment containing a combination of calcipotriene 0.005% and betamethasone dipropionate 0.064% for the treatment of psoriasis vulgaris in adults. LEO submitted the NDA for Taclonex to the FDA in March 2005. Taclonex is sold outside the US as Dovobet^® or Daivobet^®. Also in January 2006, Warner acquired the US marketing rights for Dovonex (calcipotriene 0.005%), a leading nonsteroidal topical treatment for psoriasis in the US, from Bristol-Myers Squibb Co.