Lilly to Showcase Data from its Alzheimer's Disease Portfolio at the Alzheimer's Association International Conference 2014 (AAIC 2014)

INDIANAPOLIS, July 8, 2014 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that 23 presentations will be given at the Alzheimer's Association International Conference 2014 (AAIC 2014) in Copenhagen, Denmark from July 12 – 17, 2014. Of particular interest are three oral presentations being highlighted by the Alzheimer's Association via a "reporter tips sheet" or a "featured research session" that may provide important insights to physicians, and increase knowledge through basic research that could inform future clinical research trials:

• Combination Therapy with a Plaque Specific Abeta Antibody and BACE Inhibitor Results in Dramatic Plaque Lowering in Aged PDAPP Transgenic Mice (Sun., July 13, 4:00 p.m. – 5:30 p.m. CEST, Auditorium 15): This study provides basic research to support the possibility of using combination therapy to achieve maximal removal of beta-amyloid pathology, a possible cause of Alzheimer's disease.
• Cognitive Impairment Precedes and Predicts Functional Impairment in Mild Alzheimer's Disease (Tues., July 15, 8:30 a.m. – 10:00 a.m. CEST, Auditorium 15): This study evaluates the relationship between cognitive and functional decline in mild Alzheimer's disease.
  • Also to be presented during a Poster Session (P2-390), Mon., July 14, 11:45 a.m. – 2:15 p.m.CEST
• Effect of Amyloid Imaging on Diagnosis and Management of Patients with Cognitive Decline: Impact of Appropriate Use Criterion (Wed., July 16, 2:15 p.m. – 3:45 p.m. CEST, Hall C5 A): This study looks at whether patients who meet the Appropriate Use Criteria (AUC) would be more likely to receive different care if they had a beta-amyloid imaging scan as part of their diagnostic work-up, compared to patients who do not meet the AUC.

Lilly will also present a poster, "Delayed-Start Analyses of Solanezumab Phase 3 EXPEDITION Studies in Mild Alzheimer's Disease," (Poster [P4-172], Wed., July 16, 11:45 a.m. – 2:15 p.m. CEST), which will compare effects among delayed-start and early-start treatment groups.

"We are pleased to have a strong scientific presence at this year's AAIC, highlighting our continued commitment to research and sharing key learnings with the Alzheimer's disease community as a whole," said Eric Siemers, M.D., senior medical director of Lilly's Alzheimer's disease team. "The coming together of the scientific community at this meeting is crucial as the prevalence of the disease continues to rise with over 44 million people around the world with dementia, set to reach over 75 million by 2030."¹

Additional data to be presented by Lilly researchers include:

• Employing Early Uptake Data from F18-Florbetapir Scans as an Estimate of Regional Cerebral Blood Flow: Comparison to F18-FDG (Poster [IC-P-183], Sat., July 12, 12:45 p.m. – 2:45 p.m. CEST)
• In Vivo Two-Photon Imaging of Progressive Synapse Loss and Altered Spine Dynamics in the rTg4510 Tauopathy Model (Poster [P1-281], Sun., July 13, 11:45 a.m. – 2:15 p.m. CEST)
  • Also to be presented on Sat., July 12, 12:45 p.m. – 2:45 p.m.CEST, Center Hall E
• A Comparison of In Vivo Potency in Two BACE Inhibitors as Determined in Humans and Dogs (Poster [P1-365], Sun., July 13, 11:45 a.m. – 2:15 p.m. CEST)
• Use of Quantile Regression to Characterize Solanezumab Effects across Percentiles of Disease Progression in EXPEDITION Alzheimer's Disease Trials (Poster [P1-366], Sun., July 13, 11:45 a.m. – 2:15 p.m. CEST)
• Assessing the Economic Burden of Alzheimer's Disease Patients Treated by Specialists Within Three Months of Preliminary Diagnosis of Cognitive Decline (Oral Presentation, Sun., July 13, 4:00 p.m. – 5:30 p.m. CEST, Hall A3)
• Characterisation of Tau from P301S Mouse Reveals that Seed Competent Tau Comprise Small Fibrils Composed of Hyperphosphorylated Tau (Oral Presentation, Sun., July 13, 4:00 p.m. – 5:30 p.m. CEST, Hall A1)
• Empirically Defining Trajectories of Late-Life Cognitive and Functional Decline (Poster [P3-160], Tues., July 15, 11:45 a.m. – 2:15 p.m. CEST)
• Characterisation of a Co-Culture Cell Based Model of Tau Aggregation and Propagation (Poster [P3-049], Tues., July 15, 11:45 a.m. – 2:15 p.m. CEST)
• Addressing the Challenges for Clinical Trial Design: Retrofitting Existing Tools across the Alzheimer's Disease Spectrum (Oral Presentation, Wed., July 16, 8:30 a.m. – 10:00 a.m. CEST, Hall A3)
  • Part of a Featured Research Session: "Addressing the Challenges for Clinical Trial Design: An ADNI-PPSB Pre-Competitive Cross-Pharma Collaboration"
• Measuring Change in Beta Amyloid Burden Over Time Using Florbetapir-PET and a Subcortical White Matter Reference Region (Poster [P4-316], Wed., July 16, 11:45 a.m. – 2:15 p.m. CEST)
• Effects of In Vivo Amyloid Burden on Cognition in Healthy Adults Aged 30 to 89: Initial Longitudinal Results across 3.5 Years from The Dallas Lifespan Brain Study (Poster [P4-306], Wed., July, 16, 11:45 a.m. – 2:15 p.m. CEST)
• Is Florbetapir-PET Occipital SUVR a Late Biomarker in Mild or Moderate AD Dementia as Compared to Hippocampal Volume? (Poster [P4-311], Wed., July 16, 11:45 a.m. – 2:15 p.m. CEST)
• Does Hippocampal Volume Predict Positive Amyloid Status on Florbetapir-PET in Healthy Controls and Prodromal Stages of Alzheimer's Disease?  (Poster [P4-136], Wed., July 16, 11:45 a.m. – 2:15 p.m. CEST)
• Excess Costs Associated with Possible Misdiagnosis of Alzheimer's Disease among Patients with Vascular Dementia in a UK CPRD Population (Poster [P4-339], Wed., July 16, 11:45 a.m. – 2:15 p.m. CEST)
• Regional Variation in Alzheimer's Disease Progression in a Clinical Trial Setting (Poster [P4-101], Wed., July 16, 11:45 a.m. – 2:15 p.m. CEST)
• Inclusion of Patients with Alzheimer's Disease Pathology in Solanezumab EXPEDITION 3 Using Florbetapir PET Imaging or INNO-BIA AlzBio3 CSF Aß1-42 (Poster [P4-076], Wed., July 16, 11:45 a.m. – 2:15 p.m. CEST)
• Comparing Recruitment Among Geographic Regions in Multinational Alzheimer's Disease Clinical Trials (Poster [P4-174], Wed., July 16, 11:45 a.m. – 2:15 p.m. CEST)
• Test–Retest Data for the Tau PET Imaging Agent 18F-AV-1451(previously, 18F-T807) (Poster [P4-314], Wed., July 16, 11:45 a.m. – 2:15 p.m. CEST)
• Characterization of Amino Terminal Truncations of Plaque Associated Aβ after Combination BACE Inhibitor and Antibody Therapy in Aged PDAPP Mice (Poster [P4-227], Wed., July 16, 11:45 a.m. – 2:15 p.m. CEST)

About Alzheimer's Disease
Alzheimer's disease is a fatal illness that causes progressive decline in memory and other aspects of cognition.² It is the most common form of dementia, accounting for 60 to 80 percent of dementia cases.² There are currently an estimated 44 million people living with dementia worldwide.¹ The number of people affected by dementia is expected to be more than 75 million in 2030 and 135 million in 2050.¹   

About Amyvid (Florbetapir F 18 Injection)³
Amyvid is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline. A negative Amyvid scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive Amyvid scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Amyvid is an adjunct to other diagnostic evaluations.

Limitations of Use:

• A positive Amyvid scan does not establish a diagnosis of AD or other cognitive disorder
• Safety and effectiveness of Amyvid have not been established for:
  • Predicting development of dementia or other neurologic condition
  • Monitoring responses to therapies

WARNINGS AND PRECAUTIONS

Risk for Image Misinterpretation and Other Errors

• Errors may occur in the Amyvid estimation of brain neuritic plaque density during image interpretation
• Image interpretation should be performed independently of the patient's clinical information. The use of clinical information in the interpretation of Amyvid images has not been evaluated and may lead to errors. Other errors may be due to extensive brain atrophy that limits the ability to distinguish gray and white matter on the Amyvid scan as well as motion artifacts that distort the image
• Amyvid scan results are indicative of the brain neuritic amyloid plaque content only at the time of image acquisition and a negative scan result does not preclude the development of brain amyloid in the future

Radiation Risk

• Amyvid, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure

MOST COMMON ADVERSE REACTIONS

• The most common adverse reactions reported in clinical trials were headache (1.8%), musculoskeletal pain (0.7%), blood pressure increased (0.7%), nausea (0.7%), fatigue (0.5%), and injection site reaction (0.5%)

For more information about Amyvid, please see the Prescribing Information at http://pi.lilly.com/us/amyvid‐uspi.pdf.

AM HCP ISI 10JAN2014

About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and http://newsroom.lilly.com/social-channels.

©Lilly USA, LLC 2014. All rights reserved.

Amyvid™ is a trademark of Eli Lilly and Company.

P-LLY

This press release contains certain forward-looking statements about florbetapir, a radioactive diagnostic agent indicated for brain imaging of beta-amyloid plaque density in patients with cognitive impairment who are being evaluated for Alzheimer's Disease and other causes of cognitive decline, and solanezumab, an agent being investigated as a potential treatment for Alzheimer's disease. This release reflects Lilly's current beliefs; however, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that florbetapir will be commercially successful, that solanezumab will receive regulatory approvals or, if approved, would be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

¹ Alzheimer's Disease International. Policy Brief for Heads of Government: The Global Impact of Dementia 2013 - 2050. http://www.alz.co.uk/research/GlobalImpactDementia2013.pdf. Published December 2013. Accessed on June 4, 2014.
² Alzheimer's Association. 2014 Alzheimer's Disease Facts and Figures. http://www.alz.org/downloads/facts_figures_2014.pdf. Accessed on June 4, 2014.
³ Amyvid [package insert]. Indianapolis, IN: Lilly USA, LLC; 2012.

Refer to: Stefanie Prodouz, +1 (317) 224-5331, [email protected]

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