Lilly Reports on Outcome of Phase III Study of Arzoxifene
Eli Lilly and Company announced that initial results from its pivotal, five-year, Phase III GJAD "GENERATIONS" trial for arzoxifene met its primary endpoints of significantly reducing the risk of vertebral fracture and invasive breast cancer in postmenopausal women. However, the study failed to demonstrate a statistically significant difference in key secondary efficacy endpoints, such as non-vertebral fractures, clinical vertebral fractures, cardiovascular events and cognitive function, compared to placebo. In addition, certain adverse events, including venous thromboembolic events, hot flushes and gynecological-related events, were reported more frequently in the arzoxifene group compared with placebo. After reviewing the overall clinical profile of arzoxifene in light of currently available treatments, including Lilly's own osteoporosis products, the company has decided not to submit the compound for regulatory review. The final GJAD "GENERATIONS" study results will be published in 2010.
"At Lilly, our goal is to provide innovative therapies that result in better patient outcomes," said M. Johnston Erwin, global brand development leader for the musculoskeletal platform at Lilly. "While arzoxifene met its primary efficacy objectives in this study, we are disappointed that the GENERATIONS data did not convincingly demonstrate that arzoxifene would represent a meaningful advancement in the treatment of osteoporosis."
The decision not to submit arzoxifene for regulatory review is expected to result in a third-quarter charge to earnings of approximately $.03 to $.04 per share. The company confirmed its previous 2009 earnings per share guidance range of $4.14 to $4.24 on a reported basis, or $4.20 to $4.30 on a pro forma non-GAAP basis.
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