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| |  Evista (Raloxifene) Approved in Europe for Postmenopausal Osteoporosis INDIANAPOLIS, IN -- May 9, 2000 -- Eli Lilly and Company announced at the 27th European Symposium on Calcified Tissues meeting that Evista(R) (raloxifene) has been approved in the European Union to treat postmenopausal osteoporosis, a disease that affects up to 50 percent of postmenopausal European women. Evista, first brought to markets worldwide as a postmenopausal osteoporosis preventive, has now been cleared for marketing in 35 countries to treat this highly prevalent disease. "This new treatment license is significant for Lilly and for women in the 15 European Union member countries who now have a new choice to treat osteoporosis," said Bryce Carmine, president of primary care products at Lilly. "Lilly is proud to bring to the European marketplace the first selective estrogen receptor modulator (SERM) proven to protect a postmenopausal woman's bones and reduce her risk of fracture." The basis for the European treatment license are scientific findings from the Multiple Outcomes of Raloxifene Evaluation (MORE), one of the largest osteoporosis treatment trials of its kind. According to the European product label, once-daily treatment with Evista over a three-year-period reduced an osteoporotic woman's risk of having a first spinal fracture by 50 percent and subsequent spinal fractures by 30 percent. In addition to reducing fracture risk, Evista increased bone mineral density in the hip, spine and total body. Evista provided these bone benefits without stimulating a woman's reproductive tissues or increasing her breast or uterine cancer risks. Spinal fractures are the most common and earliest occurring fracture among postmenopausal women. Studies have shown that women who sustain a spinal fracture are more likely to suffer additional spinal fractures and sustain hip fractures. Lilly intends to make Evista available worldwide for both the prevention and treatment of postmenopausal osteoporosis. To date, Evista is approved to prevent the disease in 67 countries and to treat the disease in 35 countries, with additional submissions pending. Lilly continues to support several long-term women's health studies with Evista, including the Raloxifene Use for The Heart (RUTH) trial, the Continuing Outcomes Relevant to Evista (CORE) trial and the Study of Tamoxifen and Raloxifene (STAR). Evista reached $100.5 million in sales during the first quarter of 2000, an 84 percent increase in sales over the first quarter of 1999. In the U.S., Evista recently surpassed the seven-million-prescriptions milestone. Evista is not for everyone. Evista is contraindicated for women who are or can become pregnant, are nursing, have severe liver problems or have had blood clots that have required a doctor's treatment. An infrequent but serious side effect of Evista is blood clots in the veins. The most commonly reported side effects were hot flashes and leg cramps. However, most women taking Evista did not experience these side effects. Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Related Links: Evista (raloxifene and Eli Lilly and Company.
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