Lilly Reports on Outcome of Phase III Study of ...(addition we have the largest and most pr...),Health

Date:8/18/2009

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."

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.

Lilly is in the process of contacting the clinical investigators conducting ongoing arzoxifene clinical trials. Subject to protocol requirements, the trials will be discontinued, and the patients currently enrolled will be encouraged to speak with a healthcare professional regarding other therapeutic options. Patients involved in arzoxifene clinical studies who have questions should contact their study investigator.

About GJAD "GENERATIONS" Study

The GJAD "GENERATIONS" Study is a Phase III, double-blind, randomized, placebo-controlled, five-year study of 9,354 postmenopausal women, throughout 22 countries, 60-85 years of age, with either documented osteoporosis or low bone mass. Participants were randomly assigned to arzoxifene 20 mg/day or placebo, and also received elemental calcium 500 mg/day and 400-600 IU/day vitamin D.

Primary endpoints were vertebral fractures in the osteoporosis population and invasive breast cancer in the overall study population. Secondary efficacy endpoints included non-vertebral fractures, clinical vertebral fractures, cardiovascular events (coronary events and stroke), and cognitive function. Key safety endpoints included all-cause mortality, gynecological-related events (including endometrial carcinoma and hyperplasia), and venous thromboembolic events (VTEs).

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SOURCE Eli Lilly and Company Copyright©2009 PR Newswire. All rights reserved

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