FDA approves Climara Pro to treat menopause symptoms

Berlex, Inc., a U.S. affiliate of Schering AG, Germany (NYSE: SHR), announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Climara Pro®(estradiol/levonorgestrel) transdermal system. Climara Pro, a thin, translucent patch, is the first once-a-week, combined hormone therapy for the relief of moderate to severe vasomotor symptoms associated with menopause, such as hot flashes and night sweats.

Transdermal (patch) technology allows for continuous delivery of hormones at doses much lower than in pills. Climara Pro delivers 0.015 mg per day of levonorgestrel and 0.045 mg per day of estradiol. Estradiol is the most active estrogen made by the ovary. The patch will be available in pharmacies in January 2004.

"Climara Pro offers a significant change from the hormonal treatment options of the past," said Marie Foegh, M.D., D.Sc., Vice President of Clinical Development for Female Healthcare at Berlex. "This is the first hormone therapy in the U.S. with levonorgestrel, a progestin that has been used worldwide in women's health therapies for more than 20 years, with millions of patient-years of experience." Thousands of U.S. women each day reach menopause, many of them suffering from vasomotor symptoms that negatively impact their lives. FDA approval of a new, unique option lends credibility to the fact that hormone therapy remains an important and effective way to manage those often detrimental symptoms.

"Recent studies have underscored the importance of having new options for women during menopause, and it is critical for a woman to carefully review all of her options with her healthcare provider," said James A. Simon, M.D., Clinical Professor, George Washington University, specializing in menopause, infertility, reproductive endocrinology, osteoporosis and gynecology, and a Climara Pro investigator. "New low dose Climara Pro provides another important opportunity to individualize treatment for ea

Contact: Kim Schillace, Berlex Laboratories
Porter Novelli

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