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FDA Approves Menostar (Estradiol Transdermal) for Osteoporosis Prevention Patch Delivers Half the Lowest Currently Available Estrogen Dose Requiring No Daily or Monthly Progestin MONTVILLE, NJ -- June 9, 2004 -- Berlex, the U.S. affiliate of Schering AG, Germany (NYSE: SHR), announced to today that the U.S. Food and Drug Administration (FDA) approved Menostar™ (estradiol transdermal system) 14 micrograms/day, an advancement in osteoporosis prevention in a convenient transdermal patch. This patch delivers such a low dose of plant-derived estrogen that it can be used in women with or without a uterus. Menostar is a clear, dime-sized, once-a-week patch that delivers half the dose-only 14 micrograms per day-of the lowest currently available dose of transdermal estrogen therapy for post-menopausal osteoporosis prevention. "Menostar is a fundamentally new approach to post-menopausal osteoporosis prevention. In a two-year clinical study, Menostar, with a very low dose of estrogen, did not increase the risk of endometrial hyperplasia among women with a uterus. Therefore, this patch does not require a daily or monthly concomitant progestin,"(1) said Marie Foegh, M.D., Vice President, Medical Affairs for Berlex Laboratories. "Until now, we in the medical community never knew such small amounts of estrogen could help maintain bone health. With Menostar, we can return a woman's estrogen to the lowest level proven to prevent bone loss." The extent of estrogen deficiency in post-menopausal women may pre-determine osteoporosis risk. Women with low estrogen syndrome, or those with trace or undetectable estrogen levels (estradiol levels < 5 pcg/mL), are at a 2.5 times greater relative risk for osteoporosis and debilitating bone and hip fractures compared to other post-menopausal women. In addition, women with trace or undetectable levels of estrogen combined with high concentrations of sex hormone-binding globulin (SHBG) are at up to eight times greater relative risk for developing osteoporosis. "Menostar is a dramatic new approach to preventing bone loss among women with or without a uterus. With the population of post-menopausal women expanding rapidly in the U.S., Menostar is an opportunity to serve a growing medical need," said Reinhard Franzen, President and CEO, Berlex Laboratories. "As a leader in women's health, Berlex is committed to offering novel options for women whether they seek contraception, relief of menopausal symptoms or bone protection." Clinical Trials To assess the efficacy and safety of Menostar, the FDA reviewed data from a two-year, randomized, multi-center, placebo-controlled clinical trial of 417 post-menopausal women 60 to 80 years old. After two years, Menostar increased lumbar spine bone mineral density (BMD) by three percent over baseline (p= <0.001) and 2.6 percent over placebo (p= <0.001). In addition, Menostar increased hip BMD by 0.84 percent over baseline (p= <0.001) and 1.6 percent over placebo (p= <0.001). In the clinical trial, the safety and tolerability profile of Menostar was comparable to placebo; the most frequently reported side effects were application site irritation, joint pain and leukorrhea. Results of the study indicate that Menostar does not cause clinically significant endometrial hyperplasia. Therefore, this patch does not require a daily or monthly concomitant progestin to protect against endometrial cancer among women with an intact uterus.(2) In this study, there was no difference in the number of incidents of breast cancer, blood clots or cardiovascular events in the active group over placebo. "Our study of Menostar showed that with nearly half of the lowest dose of estrogen currently available in a patch for osteoporosis prevention-about one quarter of the standard doses used for osteoporosis prevention-bone density increased to a clinically and statistically significant degree," said Bruce Ettinger, MD, Clinical Professor of Medicine at the University of California, San Francisco and lead investigator the study. "Menostar can be especially beneficial for women with extremely low estrogen by bringing their levels up just a little bit." Furthermore, transdermal delivery allows for estrogen delivery directly into the bloodstream through the skin, and therefore is not metabolized by the liver. A "first-pass effect" through the liver with oral delivery has been shown to cause increases in SHBG, triglycerides, and C-reactive protein. The transdermal delivery for Menostar is made possible through unique 3M Drug Delivery Systems technology. About Osteoporosis Despite its prevalence and debilitating effects on women's health, osteoporosis continues to be under-recognized and under-treated in post-menopausal women. According to the National Osteoporosis Foundation, as many as eight million women suffer from osteoporosis and another 22 million women have bone density deficiency, putting them at risk for bone fracture and associated complications. In fact, 24 percent of women 50 years and older who suffer a hip fracture die within a year of the fracture. About Menostar Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of "natural" estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses. Estrogens with and without progestins should not be used for the prevention of cardiovascular disease. The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625mg) combined with medroxyprogesterone acetate (MPA 2.5mg) relative to placebo. The Women's Health Initiative Memory Study (WHIMS), a sub-study of WHI, reported increased risk of developing probable dementia in post-menopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger post-menopausal women or to women taking estrogen alone therapy, such as Menostar. Estrogens and estrogen/progestin therapy should not be used in individuals with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of cancer of the breast; known or suspected estrogen-dependent neoplasia; blood clots; stroke or myocardial infarction; known or suspected pregnancy, and liver dysfunction or disease. Menostar should not be used in patients with known hypersensitivity to its ingredients. For more information and full prescribing information, please visit www.berlex.com. SOURCE: Ogilvy Public Relations Worldwide E-mail this page to a friend or colleague! To print, use this version