News Release

INDIANAPOLIS, March 9, 2021 /PRNewswire/ -- New data from 10 studies will be presented by Eli Lilly and Company (NYSE: LLY) at the upcoming virtual International Conference on Alzheimer's & Parkinson Diseases^™ 2021 (AD/PD^™ 2021), March 9-14, 2021. Lilly will present detailed results of the TRAILBLAZER-ALZ phase 2 study, which showed that donanemab treatment resulted in significant slowing of decline in a composite measure of cognition and daily function in people with early symptomatic Alzheimer's disease (AD) compared to placebo. Additional data highlight Lilly's AD program focused on developing both disease-modifying therapies that slow clinical progression by targeting the underlying causes of AD and novel diagnostics and biomarkers to enable a timely and more accurate diagnosis.

"These data bring us hope that we are closer to finding solutions for people and their families suffering from this devastating disease," said Mark Mintun, M.D., vice president of Alzheimer's disease development unit, Eli Lilly and Company. "We are proud of our research findings and encouraged by the possibility to accelerate the diagnosis of Alzheimer's disease and the development of innovative treatments to stop it."

For over 30 years, Lilly has been committed to bringing innovative AD therapies and diagnostics to patients and continues to lead the research field. Lilly's neurodegeneration pipeline reflects innovation, investments and collaborations aimed at the entire spectrum of AD, including disease-modifying therapies that target the underlying causes of the disease, symptomatic therapies, and imaging and blood biomarkers to support earlier detection.

The breadth of data being presented at the meeting reflects Lilly's expertise in blood-based screening and amyloid and tau imaging. These diagnostic strategies are also integrated into Lilly's robust approach to AD clinical trials including the TRAILBLAZER-ALZ trials. Studies being presented include (please note, times listed below are Central European Time (CET) as virtual conference will be hosted from Barcelona and may be subject to change):

Donanemab

• Donanemab Slows Progression of Early Symptomatic Alzheimer's Disease in Phase 2 Proof of Concept Trial Symposium, Saturday, March 13, 2021, 12:00-13:30 PM CET/ 6:00-7:30 AM EST

Blood Biomarker Data

• Plasma P-Tau217 Predicts Longitudinal Amyloid Accumulation, Tau Burden, Brain Atrophy and Cognitive Decline in Early Alzheimer's Disease Symposium, Wednesday, March 10, 2021, 12:00-14:00 PM CET/ 6:00-8:00 AM EST

• Prediction of Plasma Phosphorylated Tau 181 and 217 for Amyloid and Tau PET in the Population-Based Mayo Clinic Study of Aging Symposium, Friday, March 12, 2021, 10:00-12:00 PM CET/4:00-6:00 AM EST

• Plasma Amyloid, P-Tau217, NFL, and GFAP as Biomarkers of Amyloid Pathology in Cognitively Healthy Individuals Symposium, Saturday, March 13, 2021, 8:00-10:00 AM CET/ 2:00-4:00 AM EST

• Plasma P-Tau 181, P-Tau 217 and other Blood-Based Alzheimer's Disease Biomarkers in a Multi-ethnic, Community Study Symposium, Saturday, March 13, 2021, 8:00-10:00 AM CET/2:00-4:00 AM EST

• Prediction of Alzheimer's Disease Dementia Using Plasma P-Tau217 in Combination with other Non-Invasive Measures: Longitudinal Study from the Bio finder and ADNI Cohorts Symposium, Saturday, March 13, 2021, 8:00-10:00 AM CET/ 2:00-4:00 AM EST 

• Plasma Phospho-Tau Identifies Alzheimer's Disease Co-Pathology in Patients with Lewy Body Disease with Dementia Symposium, Saturday, March 13, 2021, 8:00-10:00 AM CET/ 2:00-4:00 AM EST

 Public/Private Collaborations

• Advances in Alzheimer's Disease Prevention Trials: DIAN-TU Updates and Transition to Blood Test Symposium, Saturday, March 13, 2021, 12:00-13:30 PM CET/6:00-7:30 AM EST

Mevidalen/D1PAMs

• Preclinical Pharmacology and Early Clinical Development of D1 Positive Allosteric Modulators with Therapeutic Potential for Neuropsychiatric Disorders Symposium, Wednesday, March 10, 2021, 12:00-14:15 PM CET/6:00-8:15 AM EST

• Results of the Presence Study Evaluating Mevidalen for the Treatment of Lewy Body Dementia (LBD) Symposium, Sunday, March 14, 2021 10:00-11:45 AM CET/ 4:00-5:45 AM EST

About Alzheimer's Disease
Alzheimer's disease is a fatal illness that causes progressive decline in memory and other aspects of cognition. Dementia due to Alzheimer's disease is the most common form of dementia, accounting for 60 to 80 percent of all cases¹. There are currently over 50 million people living with dementia around the world, with numbers expected to increase to nearly 152 million by 2050². Almost 10 million new cases of dementia are diagnosed each year worldwide, implying one new case every 3 seconds, and a significant increase in the caregiving burden placed on society and families.  In the US alone, there was an increase of 8 million new caregivers from 2015 to 2020³. The current annual societal and economic cost of dementia is estimated at $1 trillion, an amount that is expected to double by 2030 unless we find a way to slow the disease.

About Avid Radiopharmaceuticals
The mission of Avid Radiopharmaceuticals, a wholly owned subsidiary of Lilly, is to discover and develop radiopharmaceuticals and imaging methods that improve global health by accelerating the development of new medicines and enabling a tailored approach to healthcare.

About Eli Lilly and Company
Lilly is a global health care leader that unites caring with discovery to create medicines that 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 lilly.com and lilly.com/newsroom. P-LLY

Lilly Cautionary Statement Regarding Forward-Looking Statements 

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about donanemab as a potential treatment for people with early symptomatic Alzheimer's disease and reflects Lilly's current beliefs and expectations. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that future study results will be consistent with study results to date, that donanemab will prove to be a safe and effective treatment, or that donanemab will receive regulatory approval. For further discussion of these and other risks and uncertainties, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

¹ https://www.alz.org/alzheimers-dementia/facts-figures 
² https://www.alz.co.uk/research/WorldAlzheimerReport2019.pdf 
³ https://www.aarp.org/content/dam/aarp/ppi/2020/05/full-report-caregiving-in-the-united-states.doi.10.26419-2Fppi.00103.001.pdf

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SOURCE Eli Lilly and Company