INDIANAPOLIS, Aug. 4, 2015 /PRNewswire/ -- Eli Lilly and
Company (NYSE:LLY) today notified the University of California, San Diego (UCSD) of its
intent to end its contract with the university for the management
of the Anti-amyloid Treatment in Asymptomatic Alzheimer's disease
(A4) study. The A4 study is a novel clinical trial testing
solanezumab in the preclinical stage of Alzheimer's disease in
older individuals who have evidence of amyloid in their brains on a
PET scan, but do not show symptoms of memory impairment. A4 has
been managed by the Alzheimer's Disease Cooperative Study (ADCS) at
UCSD. Lilly, the National Institutes of Health (NIH) and multiple
philanthropic organizations fund the study.
Dr. Paul Aisen, who had been
director of ADCS, and many members of the ADCS staff left UCSD this
summer to join the University of Southern
California. Both universities are now engaged in legal
proceedings related to this matter. During this period, Lilly has
been carefully evaluating the best course to ensure the successful
continuation and eventual completion of the A4 study.
From the outset of this unfortunate dispute, Lilly has publicly
stated that the company's objectives are to maintain the safety of
the A4 participants, ensure scientific and data integrity for the
study and maintain our obligations as the regulatory sponsor.
After a thorough evaluation of the on-going situation, Lilly has
determined that it is in the best interest of the A4 study and its
participants to end UCSD's management of the study. The A4 study
will continue uninterrupted as the company initiates discussions
with the University of Southern
California about transitioning management and oversight of
the study, while the company will simultaneously work with UCSD on
a transition plan.
"Lilly continues to be committed to the continuation and
completion of this landmark study," said Phyllis Ferrell, Alzheimer's Platform Leader for
Lilly. "We are extremely grateful for the ongoing efforts of the A4
study participants, study investigators and the NIH. We wish to
thank UCSD for its work to date and cooperation as the A4 study
transitions. Lilly has many ongoing collaborations with researchers
at UCSD and within the UC system more broadly, and nothing in our
decision concerning the A4 study should be read to reflect any
diminished enthusiasm in working with UCSD on these other important
projects."
About solanezumab
Solanezumab is Lilly's Phase 3
monoclonal antibody being studied as a potential therapy for
patients with mild Alzheimer's disease. Solanezumab binds to
soluble monomeric forms of amyloid-beta after it is produced,
allowing it to be cleared before it clumps together to form
beta-amyloid plaques.
About Alzheimer's disease
Alzheimer's disease is a
fatal illness that causes progressive decline in memory and other
aspects of cognition. It is the most common form of dementia,
accounting for 60 to 80 percent of dementia cases.1
There are currently an estimated 44 million people living with
dementia worldwide.2 The number of people affected by
dementia is expected to be more than 75 million in 2030 and 135
million in 2050.2 Estimates vary, but experts suggest
that as many as 5.3 million Americans may have Alzheimer's
disease.1
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
newsroom.lilly.com/social-channels.
(P-LLY)
This press release contains forward-looking statements (as
that term is defined in the Private Securities Litigation Reform
Act of 1995) about solanezumab as a potential treatment for
patients with Alzheimer's disease and reflects Lilly's current
belief. However, as with any pharmaceutical product, there
are substantial risks and uncertainties in the process of
development and commercialization. Among other things, there can be
no guarantee that future study results will be consistent with the
results to date or that solanezumab will achieve its primary study
endpoints or receive regulatory approvals. For further
discussion of these and other risks and uncertainties, see Lilly's
most recent 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 Alzheimer's Association. 2015 Alzheimer's Disease
Facts and Figures. Alzheimer's & Dementia
2015;11(3)332+.
2 Alzheimer's Disease International and World Health
Organization Dementia Statistics. Available at:
http://www.alz.co.uk/research/statistics. Accessed May 27, 2015.
Refer to: Nicole Hebert;
hebert_nicole@lilly.com; 317.701.9984 (Lilly)
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SOURCE Eli Lilly and Company