MEDIA RELEASE PR35757
Lilly Reports on Outcome of Phase III Study of Arzoxifene
INDIANAPOLIS, Aug. 19 /PRNewswire-AsiaNet/ --
Based on Preliminary Phase III GJAD Study Results, Lilly Concludes Arzoxifene's Clinical Profile Does Not
Support Regulatory Submission
Eli Lilly and Company (NYSE: LLY) announced today 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 results of arzoxifene's GENERATIONS study serve as a reminder of the high risks associated with
pharmaceutical innovation," commented John Lechleiter, Ph.D., Lilly chairman and chief executive officer. "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."
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).
The primary vertebral fracture endpoint was based on three-year data, consistent with FDA guidance on
development of osteoporosis products, whereas the primary invasive breast cancer analysis, secondary outcome
analyses and safety analyses were based on four-year data.
About Lilly
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of 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.
C-LLY
Forward Looking Statement
This press release contains forward-looking statements that are based on management's current expectations,
but actual results may differ materially due to various factors. There are significant risks and uncertainties in
pharmaceutical research and development. There can be no guarantees with respect to pipeline products that the
products will receive the necessary clinical and manufacturing regulatory approvals or that they will prove to be
commercially successful. The company's results may also be affected by such factors as competitive developments
affecting current products; rate of sales growth of recently launched products; the timing of anticipated regulatory
approvals and launches of new products; regulatory actions regarding currently marketed products; other
regulatory developments and government investigations; patent disputes and other litigation involving current and
future products; the impact of governmental actions regarding pricing, importation, and reimbursement for
pharmaceuticals; changes in tax law; asset impairments and restructuring charges; acquisitions and business
development transactions; and the impact of exchange rates and global macroeconomic conditions. For additional
information about the factors that affect the company's business, please see the company's latest Form 10-Q filed
July 2009 and Form 10-K filed February 2009. The company undertakes no duty to update forward-looking
statements.
SOURCE: Eli Lilly and Company
CONTACT: Teresa Shewman,
Global Product Communications,
+1-317-292-8940,
Mark E. Taylor,
Corporate Communications,
+1-317-276-5795,
Phil Johnson,
Investor Relations,
+1-317-655-6874,
all of Eli Lilly and Company
(LLY)
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