Date: December 12, 2012
For Release: Immediately
Refer to: Stefanie Prodouz, +1
(317) 224-5331, prodouzs@lilly.com (Media)
Philip Johnson, +1 (317)
655-6874, johnson_philip_l@lilly.com (Investors)
Lilly Provides Update on Next Steps for Solanezumab
INDIANAPOLIS - Eli Lilly and
Company (NYSE: LLY) today provided an update on the next steps
planned for solanezumab, its Phase 3 monoclonal antibody being
studied as a potential therapy for patients with mild Alzheimer's
disease. Following discussions with regulators in the U.S.,
Europe and Canada, Lilly plans to conduct an additional
Phase 3 study of solanezumab in patients with mild Alzheimer's
disease. Additional details, including study design and length, are
still being determined. Lilly expects to initiate this study no
later than Q3 2013.
Based on recent meetings with the U.S. Food and Drug
Administration (FDA), Lilly does not intend to submit a Biologics
License Application (BLA) at this time in the U.S. based solely on
the existing analyses of data from the EXPEDITION studies. Lilly
will continue to analyze and discuss the data from the two, Phase
3, double-blind, placebo-controlled solanezumab EXPEDITION studies
with regulators globally to determine the regulatory paths forward
in different regions. It is possible that different courses of
action could be taken in different jurisdictions.
Independent analyses of the Phase 3 solanezumab EXPEDITION data
were conducted by the Alzheimer's Disease Cooperative Study (ADCS),
an academic research consortium, and presented at the annual
meeting of the American Neurological Association (ANA) on
Oct. 8, 2012, and at the Clinical
Trial on Alzheimer's Disease (CTAD) meeting on Oct. 29, 2012.
"Based on both the independent analyses by the ADCS, as well as
our own," said Eric Siemers, senior
medical director of Lilly's Alzheimer's disease team, "we believe
the results demonstrating a slowing of cognitive decline in
patients with mild Alzheimer's disease treated with solanezumab are
the first data from Phase 3 clinical trials that support the
amyloid hypothesis."
"We remain encouraged and excited by the solanezumab data," said
David Ricks, senior vice president
and president, Lilly Bio-Medicines. "We are committed to working
with the FDA and other regulatory authorities to bring solanezumab
to the millions of patients and caregivers suffering from this
devastating disease who urgently need this potential
treatment."
About solanezumab
Solanezumab is a Phase 3, monoclonal antibody that 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 the EXPEDITION Trials
The EXPEDITION trials consisted of two Phase 3, double-blind,
placebo-controlled solanezumab trials in patients with
mild-to-moderate Alzheimer's disease in 16 countries around the
world. In both of the EXPEDITION study protocols, mild Alzheimer's
disease was defined as a baseline Mini-Mental Status Examination
(MMSE) score of 20 to 26 and moderate Alzheimer's disease was
defined as a baseline MMSE score of 16 to 19.
The designs of EXPEDITION1 and EXPEDITION2 were the same.
Patients aged 55 years or older were eligible to enroll in these
studies; EXPEDITION1 enrolled 1,012 patients and EXPEDITION2
enrolled 1,040 patients. Patients received either 400mg of
solanezumab infused intravenously (IV) or placebo every four weeks
for approximately 18 months. Both EXPEDITION trials allowed
patients to remain on stable standard of care (defined as their
existing treatment regimen) during these studies. More than 85
percent of the patients in these trials were taking an
acetycholinesterase inhibitor and / or memantine.
While primary endpoints, both cognitive and functional, were not
met in the two Phase 3, double-blind, placebo-controlled
solanezumab EXPEDITION trials in patients with mild-to-moderate
Alzheimer's disease, a pre-specified secondary analysis of pooled
data in patients with mild Alzheimer's disease showed a
statistically significant slowing of cognitive decline. This
finding represented a 34 percent reduction in decline. Over the 18
months of the EXPEDITION studies, the difference between patients
treated with solanezumab versus placebo increased at a relatively
constant rate over time.
In the pooled analyses of the EXPEDITION studies, the only
adverse event with an incidence of at least 1 percent that occurred
statistically significantly more in the solanezumab group than in
the placebo group was angina (1.1 percent versus 0.2 percent). The
incidence of vasogenic edema (ARIA-E) was approximately 1 percent,
occurring in 11 patients treated with solanezumab and 5 patients on
placebo, which was not statistically significant.
An ongoing, open-label extension study, EXPEDITION-EXT, is fully
enrolled and will continue as planned.
About Alzheimer's disease
Alzheimer's disease, the most common form of dementia, causes
progressive decline in memory and other aspects of cognition.,
Researchers do not know exactly what causes Alzheimer's disease and
there are currently no approved treatments shown to slow the
progression of this devastating disease, only treatment options
that reduce certain symptoms of the disease. 1,, Alzheimer's
Disease International (ADI) estimates that there are currently 35.6
million people with dementia worldwide, with 7.7 million new cases
each year (which implies one new case every four seconds). The
number of people affected is estimated to be over 115 million by
2050.4 Estimates vary, but experts suggest that as many as 5.4
million Americans may have Alzheimer's disease.3
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. P-LLY
This press release contains certain forward-looking statements
about solanezumab. This release 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 study findings to
date, or that solanezumab will be approved as a product or will
prove to be commercially successful. For further discussion of
these and other risks and uncertainties, see Lilly's filings with
the United States Securities and Exchange Commission. Lilly
undertakes no duty to update forward-looking statements.
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285
U.S.A.
www.lilly.com
National Institute of Neurological Disorders and Stroke.
"Dementia: Hope Through Research." Available at:
http://www.ninds.nih.gov/disorders/dementias/
detail_dementia.htm#1908919213. Accessed on August 13, 2012.
Alzheimer's Association. "2012 Alzheimer's Disease Facts and
Figures." Available at:
http://www.alz.org/downloads/facts_figures_2012.pdf. Accessed on
August 13, 2012.
Robert P, Ferris S, Gauthier S, Ihl R, Winblad B, Tennigkeit F.
Review of Alzheimer's disease Scales: Is There a Need for a New
Multi-domain Scale for Therapy Evaluation in Medical Practice?.
Alzheimer's Research & Therapy. 2010; 2(24): 1-13.
Perrin, R., et al. "Multimodal techniques for diagnosis and
prognosis of Alzheimer's disease." Nature 2009 (461); 916-922.
Alzheimer's Disease International. "Dementia Statistics."
Available at: http:// www.alz.co.uk/research/statistics. Accessed
on August 13, 2012.
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