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Lilly Launches Its First Phase III Trial for Treatment of Alzheimer's Disease

Late-stage IDENTITY study of once-daily, oral agent is now enrolling


INDIANAPOLIS, March 31 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY) has announced today the start of a Phase III clinical trial studying LY450139, an investigational gamma secretase inhibitor for the treatment of mild to moderate Alzheimer's disease. LY450139 is being tested to see if it can slow the progression associated with Alzheimer's disease by inhibiting gamma-secretase, an enzyme that can create a sticky protein called amyloid beta. Current Alzheimer's disease theory is that subtypes of amyloid beta clump together into plaques that eventually kill off brain cells. By blocking gamma secretase, there is less amyloid beta formed, potentially slowing brain-cell death.

Slowing the rate of disease progression could preserve independent functioning and quality of life for Alzheimer's patients in the milder stages of the disease, potentially delaying the onset of the severe stages of the disease. Currently available treatments for Alzheimer's disease have no documented effect on amyloid beta. They provide modest improvements in symptoms but do not slow the underlying disease process.

The IDENTITY Trial - Interrupting Alzheimer's Dementia by EvaluatiNg Treatment of AmyloId PaThologY

IDENTITY is a randomized, double-blind, placebo-controlled trial that will be conducted in the U.S. and 21 additional countries. As part of IDENTITY, 1,500 patients will be studied for 21 months, and an open-label extension will be available to all participants completing the study. Patients who are taking currently available symptomatic treatments for Alzheimer's disease can continue treatment during their participation in IDENTITY. Because the IDENTITY study also incorporates a "randomized delayed start" design, even those subjects initially assigned to the placebo arm of the study will be started on active LY450139 treatment sometime before the end of the 21-month study period. Both the subjects and investigators will be blinded to the exact timing of this delayed start of study drug administration.

"Alzheimer's is a devastating disease that destroys brain cells, affecting everything from a patient's memory to their work and social life. Currently available medications treat the symptoms of Alzheimer's disease but have not been shown to change its underlying progression, creating an urgent unmet medical need. Today, we are proud to announce the start of the IDENTITY clinical trial and hold hope that LY450139 will represent an advance in the attempt to slow the progression of this fatal disease. We encourage patients or their caregivers to review the enrollment criteria for IDENTITY to see if they are eligible to participate," said Eric Siemers M.D., Medical Director, Alzheimer's disease research for Eli Lilly and Company.

Alzheimer's disease is a progressive neurodegenerative condition that is the most common cause of dementia in patients over 65 years of age. Estimates show that 6-8% of people over age 65 are affected by Alzheimer's disease(1), totaling approximately 5 million people in the United States alone(2). Every 72 seconds, an American is developing Alzheimer's disease(3), and it is the seventh-leading cause of death in the United States(4). The direct and indirect health care costs associated with Alzheimer's disease in the U.S. are estimated to be about $150 billion(5). In 2005, the total cost worldwide was estimated at $315.4 billion(6).

Given the aging population, without the availability of medicines that delay or prevent the onset of Alzheimer's disease, the number of affected people is expected to at least triple by the year 2050 in developed nations(7). The average duration between onset of symptoms and death due to complications of Alzheimer's disease is about 8-10 years(8). The burden to caregivers and health care costs can increase dramatically in the late stages of Alzheimer's disease, when patients cannot maintain independent function and are frequently bedridden.

To more completely characterize the disease-modifying effects of LY450139, a number of optional biomarker sub-studies will be available to patients. These optional sub-studies will utilize new brain-scanning techniques to determine the amount of amyloid beta plaque in the brain, employ other, more established scanning techniques to examine brain structure and function, and evaluate a number of additional biochemical measures of Alzheimer's disease. By determining the effect of LY450139 on these objective biomarkers, a more complete understanding of the effect of LY450139 on underlying Alzheimer's disease pathology is possible.

Additional information regarding the IDENTITY trial, including global recruitment sites, may be found by visiting or, or by calling 1-877-CTLilly (1-877-285-4559).

About LY450139

LY450139 inhibits gamma secretase, an enzyme that cuts a protein, creating a shorter, sticky protein called amyloid beta. Alzheimer's disease theory suggests that some subtypes of amyloid beta clump together into plaques that eventually kill off brain cells. Clinical studies have examined the effect of LY450139 on amyloid beta in blood and cerebrospinal fluid. The most frequently occurring side effects experienced in earlier clinical studies with LY450139 include diarrhea, upset stomach, and fatigue. For a more complete listing of potential side effects, prospective clinical trial participants should refer to the informed consent document.

About Lilly

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class 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. Additional information about Lilly is available at P-LLY

This press release contains forward-looking statements about the potential of the investigational compound LY450139 and reflects Lilly's current beliefs. However, as with any pharmaceutical product under development, there are substantial risks and uncertainties in the process of development and regulatory review. There is no guarantee that the product will receive regulatory approvals, or that the regulatory approval will be for the indication(s) anticipated by the company. There is also no guarantee that the product will prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filing with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

(1) Small, GW, Rabins, PV, Barry, PP, Buckholtz, NS, DeKosky, ST,

Ferris, SH, Finkel, SI, Gwyther, LP, Khachaturian, ZS, Lebowitz, BD,

McRae, TD, Morris, JC, Oakley, F, Schneider, LS, Streim, JE,

Sunderland, T, Teri, LA, Tune LE. Diagnosis and Treatment of

Alzheimer Disease and Related Disorders: Consensus Statement of the

American Association for Geriatric Psychiatry, the Alzheimer's

Association, and the American Geriatrics Society. JAMA 1997; 278:


(2) Alzheimer's Association. "2008 Alzheimer's Disease Facts and

Figures." Available at:

Accessed March 21, 2008.

(3) American Public Health Association. "Mind Your Memory & Alzheimer's Disease!" Available at: fal l07/alzheimer.htm. Accessed March 21, 2008.
(4) Centers for Disease Control and Prevention. "National Vital

Statistics Reports." Available at: Accessed

March 21, 2008.

(5) Alzheimer's Association. "2008 Alzheimer's Disease Facts and

Figures." Available at:

Accessed March 21, 2008.

(6) Wimoa, Anders, Bengt Winblada, and Linus J. Jonssonb. An estimate of

the total worldwide societal costs of dementia in 2005. Alzheimer's &

Dementia (2007) 3:81-91.

(7) Population Division of the Department of Economic and Social Affairs

of the United Nations Secretariat.

"World population prospects: the 1996 revision." Washington, DC


(8) National Institute on Aging. "Alzheimer's Disease Fact Sheet."

Available at Accessed

March 21, 2008.

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SOURCE Eli Lilly and Company
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