Lilly Voluntarily Terminates Phase II Study for LY2886721, a Beta Secretase Inhibitor, Being Investigated as a Treatment for

 Lilly Voluntarily Terminates Phase II Study for LY2886721, a Beta Secretase
     Inhibitor, Being Investigated as a Treatment for Alzheimer's Disease

Decision does not impact other Lilly Alzheimer's compounds in development

PR Newswire

INDIANAPOLIS, June 13, 2013

INDIANAPOLIS, June 13, 2013 /PRNewswire/ --Eli Lilly and Company (NYSE: LLY)
today announced it has stopped its Phase II study (BACC) for LY2886721, a beta
secretase (BACE) inhibitor being investigated as a once daily treatment for
its potential to slow the progression of Alzheimer's disease. The decision to
terminate the study was due to abnormal liver biochemical tests. Clinical
study investigators have been notified.

"While stopping this Phase II study for our BACE inhibitor is disappointing,
patient safety is of utmost importance to Lilly," said Jan M. Lundberg, Ph.D.,
executive vice president, science and technology, and president, Lilly
Research Laboratories. "Discovering and developing medicines for devastating
diseases like Alzheimer's is fraught with many challenges, but Lilly's 25-year
commitment to bringing medicines to the millions of Alzheimer's disease
patients who are waiting will not wane."

The cases of abnormal liver biochemical tests were identified as part of
routine monitoring. Lillywill continue tomonitor all participants with
abnormal liver biochemical tests.

Based on the information Lilly has today, it believes that the abnormal liver
biochemical tests observed in this study are not related to the BACE mechanism
and continues to be interested in developing BACE inhibitors for the benefit
of patients with Alzheimer's disease. Lilly will further evaluate this data
prior to determining next steps for the entire LY2886721 clinical development
program.

The company expects to incur a financial charge associated with the decision
to stop this trial.However, the amount of this charge is not expected to be
material and is not expected to result in a change to the company's
previously-issued 2013 financial guidance.

About Alzheimer's disease

The total number of new cases of dementia each year worldwide is nearly 7.7
million, which is the equivalent of one new case every 4 seconds.^i According
to different estimates, between 2 and 10 percent of all cases of dementia
start before the age of 65. Advancing age is the strongest risk factor for
Alzheimer's disease, with age-specific prevalence nearly doubling every 5
years beyond the age of 65.^i The total estimated worldwide cost of dementia
was $604 billion in 2010.^i

About Lilly's Neuroscience Pipeline

Lilly currently has eight potential new medicines in its clinical development
pipeline being evaluated to treat neuroscience-related diseases and disorders,
including: schizophrenia, Alzheimer's disease, depression, bipolar disorder,
migraine prevention and osteoarthritis pain. Of the eight potential new
medicines, two are currently in Phase III clinical development – edivoxetine
and solanezumab.

About Eli Lilly and Company

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. Additional information about Lilly is available at
www.lilly.com.

This press release contains certain forward-looking statements about
LY2886721, a beta secretase (BACE) inhibitor being investigated as a potential
treatment for Alzheimer's disease, and 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 the study findings to date, that this or
other BACE inhibitors that might be developed by Lilly in the future will
receive regulatory approval or, if approved, would be commercially
successful.For further discussion of these and other risks and uncertainties,
see Lilly's filings with theUnited States Securities and Exchange Commission.
Lilly undertakes no duty to update forward-looking statements.

C-LLY

[i] Alzheimer's Disease International and World Health Organization 2012
report: Dementia: a public health priority. Available at:
http://www.who.int/mental_health/publications/dementia_report_2012. Accessed
on August 11, 2012.

(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO )

Refer to: Eva Groves, 1-317-224-4642 or egroves@lilly.com

SOURCE Eli Lilly and Company

Website: http://www.lilly.com
 
Press spacebar to pause and continue. Press esc to stop.