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FDA Approves Osteoporosis Indication for Climara Pro

WAYNE, N.J., January 4, 2006 -- Berlex, Inc., a U.S. affiliate of Schering AG, Germany , announced today that the FDA has approved the hormone therapy patch, Climara Pro (estradiol/levonorgestrel transdermal system), for the prevention of postmenopausal osteoporosis. Climara Pro was approved by the FDA in November 2003 as a treatment for moderate to severe vasomotor symptoms such as hot flashes and night sweats associated with menopause. Now Climara Pro is the only combination once-a-week hormone therapy patch approved for the prevention of postmenopausal osteoporosis and the relief of vasomotor symptoms associated with menopause.

"While it has long been accepted that estrogen helps maintain bone density following menopause, our studies, and this new indication, solidify the positive effect that Climara Pro has on bones, while helping women manage moderate to severe vasomotor symptoms associated with menopause," said Paul Korner, M.D., Executive Director, Medical Affairs for Female Healthcare at Berlex.

The transdermal technology of Climara Pro allows for week-long continuous delivery of the hormones estradiol (0.045 mg/day), the same estrogen made by the ovaries prior to menopause, and levonorgestrel (0.015 mg/day) which helps protect the endometrium. Climara Pro delivers the hormones through a thin, translucent patch that is easily affixed to the skin and is virtually invisible after being applied. Like Climara (estradiol transdermal system), Berlex's once-a-week estrogen-only patch, Climara Pro delivers the hormones continuously and directly through the skin, with the benefits of unique 3M Drug Delivery Systems technology. With the addition of levonorgestrel, Climara Pro is indicated for use by women with an intact uterus, whereas Climara is appropriate for women who have had a hysterectomy.

Osteoporosis Data

Climara Pro was shown to be safe and effective in the prevention of postmenopausal bone loss in a multicenter, double-blind, randomized, placebo-controlled study involving 150 women. During the two-year treatment period, women treated with Climara Pro significantly maintained bone mineral density at the lumbar spine and hip compared to those on placebo.

Menopause Management Data

Two well-controlled, randomized clinical trials showed that Climara Pro rapidly and effectively controlled menopausal symptoms. For many patients, the frequency and severity of hot flashes was significantly reduced as early as week one, and 90 percent of women experienced an 80 percent reduction in hot flash frequency by week 12.

Climara Pro has an acceptable side effect profile. Clinical trial participants using Climara Pro also experienced a low skin irritation rate, no effect on body weight and a bleeding profile comparable to other combination hormone therapies.

Estrogen/progestin combinations should not be used by women with known or suspected pregnancy, breast cancer, estrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, active thrombophlebitis, thromboembolic disorders or stroke, liver dysfunction or disease, or any known hypersensitivity to estrogen, progestin or any Climara Pro transdermal system components. Estrogens with or without progestins should not be used to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase a woman's risk of heart attacks, strokes, breast cancer, and blood clots. A woman and her healthcare provider should discuss regularly whether she still needs estrogen treatment. In the absence of data on Climara Pro comparable in scope to that of the Women's Health Initiative (WHI), the risks identified in the WHI should be assumed to be similar for all postmenopausal hormone therapy. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should be considered only for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.

Source: Schering AG

Posted: January 2006