August 24, 2004

FEMTRACE APPROVED BY FDA TO RELIEVE VASOMOTOR SYMPTOMS OF MENOPAUSE

Warner Chilcott Plc's Femtrace (estradiol acetate) tablets were approved by the Food and Drug Administration to be used for relieving the vasomotor symptoms of menopause. The company expects to launch the pharma brand treatment in the first quarter of 2005.

The FDA approved all dosage strengths of Femtrace--0.45 mg, 0.9 mg and 1.8 mg; however, the pharmaceutical name was not approved for the secondary indication of vulvar-vaginal atrophy.

Femtrace is the first of three applications that Warner Chilcott filed with the FDA. Femhrt LO (norethindrone acetate/ethinyl estradiol), a low-dose version of Femhrt, and a line extension to the antibiotic Doryx (doxycycline hyclate) for an acne treatment indication, are expected to gain approval during the first six months of 2005.

The Northern Ireland-based firm also said that, based on recent meetings with LEO Pharma S/A, it expects a New Drug Application for Dovobet (calcipotriol/betamethasone dipropionate), designed for treating psoriasis, will be filed by March 2005. The company has agreed to license Dovobet from LEO once the pharmaceutical brand is approved for use in the United States.

Lastly, Warner Chilcott announced that it will end its development of a metronidazole vaginal ring for treating bacterial vaginosis and a fluconazole vaginal ring for treating candidiasis.