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Lilly pulls arzoxifene development

US firm halts development of promising bone treatment after it failed to meet key secondary endpoints

Eli Lilly & Co has stopped development of arzoxifene, its experimental bone drug, after study results showed that it did not prevent non-vertebral fractures and cardiovascular events.

Initial results from the pivotal five-year phase III GJAD Generations trial for arzoxifene met primary endpoints to significantly reduce 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 fracture, clinical fractures, cardiovascular events and cognitive function, compared to placebo.

The study also revealed a number of adverse reactions, including venous thromoembolic events, hot flushes and gynaecological-related events. Following the study results for arzoxifene, which was once seen as one of Lilly's most promising treatments, the company has decided not to submit the drug for regulatory review.

"The results of arzoxifene's Generations study serve as a reminder of the high risks associated with pharmaceutical innovation," said Lilly chairman and CEO, Dr John Lechleiter.

"Despite this setback, our business remains strong, supported by the growth of key marketed products. In addition, we have the largest and most promising clinical stage pipeline in our history with more than 60 molecules in clinical development, including a late-stage pipeline targeting unmet medical needs in areas such as Alzheimer's disease, cancer and diabetes," he added.

Subject to protocol, trials for arzoxifene will be discontinued and patients enrolled will be encouraged to talk to their doctor regarding other treatments.

The GJAD Generations is a phase III, double-blind, randomised, placebo-controlled, five-year study of 9,354 postmenopausal women in 22 countries, aged 60-85 years old, with either documented osteoporosis or low bone mass. Trial participants were randomly assigned to arzoxifene 20mg/day or placebo, and also received elemental calcium 500mg/day and 400-600 IU/day vitamin D.

19th August 2009

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