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Phase III Trial Showed Investigational Compound Arzoxifene Was Superior to Evista(R) (raloxifene HCl) in Increasing BMD in Postmenopausal Women with Osteoporosis
Date:3/23/2009

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"The significant increases in BMD and suppression of markers of bone turnover seen in these data show the potential benefits of arzoxifene for the treatment of osteoporosis in postmenopausal women," said investigator Jose Zanchetta, M.D., specialist in osteology and mineral metabolism, Metabolic Research Institute, Buenos Aires, Argentina. "I'm encouraged by these results and interested in seeing the next Phase III data for arzoxifene."

These data are from the "NEXT" Study, the second of three Phase III trials for arzoxifene. In September 2008, results from the "FOUNDATIONS" Phase III prevention study were first presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in Montreal. The third Phase III trial, the "GENERATIONS" Study, is a 5-year, randomized, double-blind, placebo-controlled study assessing the effects of arzoxifene on vertebral fracture incidence and on invasive breast cancer incidence in postmenopausal women with osteoporosis or with low bone density. Results from that trial are anticipated in late 2009.

"We are pleased with the results of the 'NEXT' Study and its implications for arzoxifene as a potential treatment option for postmenopausal women with osteoporosis," said Adrien Sipos, M.D., Ph.D., medical director for Eli Lilly and Company. "We are committed to research that will help bring innovative prevention and treatment options to patients suffering from this devastating disease, which affects one in three women over 50." (2)

Osteoporosis is a disease in which bones become fragile and more likely to break. Primary osteoporosis, which is deterioration of bone mass that is unassociated with other chronic illness, is related to aging and decreased gonadal function, including menopause. If not prevented, or if left untreated, osteoporosis can progress painlessly until a bone breaks. These broken bones, or fractures,
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SOURCE Eli Lilly and Company
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