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

Indianapolis (ots/PRNewswire) -

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

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 US$150 billion(5). In 2005, the total cost
worldwide was estimated at US$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
www.clinicaltrials.gov or www.lillytrials.com, 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 www.lilly.com.

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:
1363-1371.
(2) Alzheimer's Association. "2008 Alzheimer's Disease Facts and
Figures." Available at:
http://www.alz.org/national/documents/report_alzfactsfigures2008.pdf.
Accessed March 21, 2008.
(3) American Public Health Association. "Mind Your Memory & Alzheimer's
Disease!" Available at:
http://www.apha.org/membergroups/newsletters/sectionnewsletters/public_ed
u/fall07/alzheimer.htm. Accessed March 21, 2008.
(4) Centers for Disease Control and Prevention. "National Vital
Statistics Reports." Available at:
http://www.cdc.gov/nchs/data/nvsr/nvsr55/nvsr55_19.pdf. Accessed
March 21, 2008.
(5) Alzheimer's Association. "2008 Alzheimer's Disease Facts and
Figures." Available at:
http://www.alz.org/national/documents/report_alzfactsfigures2008.pdf.
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
(1998).
(8) National Institute on Aging. "Alzheimer's Disease Fact Sheet."
Available at
http://www.nia.nih.gov/Alzheimers/Publications/adfact.htm. Accessed
March 21, 2008.

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Contact:
Christine Van Marter, Eli Lilly and Company, +1-317-651-1473: Photo:
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