Eli Lilly and Company
) reached a 52-week high of $50.94 on Monday with the company
reporting full results on its Alzheimer's disease candidate,
Eli Lilly had previously reported top-line data on the candidate
from the phase III, double-blind, placebo-controlled EXPEDITION
studies in August 2012. The studies were conducted in patients with
mild-to-moderate Alzheimer's disease.
Although solanezumab failed to meet its primary endpoints in
both the phase III EXPEDITION studies, the candidate demonstrated
promising potential in slowing cognitive decline. At that time, Eli
Lilly had announced that the Alzheimer's Disease Cooperative Study
(ADCS) will conduct an independent analysis of the EXPEDITION study
The ADCS' independent analysis of solanezumab was presented at
the annual meeting of the American Neurological Association
Results from the EXPEDITION 1 study showed that patients with
mild Alzheimer's disease taking solanezumab experienced a slowing
of cognitive decline compared to patients on placebo (42% reduction
in decline at the endpoint of the 18-month study). Meanwhile,
results from EXPEDITION 2 showed a 20% reduction in cognitive
decline in patients with mild Alzheimer's disease taking
Pooled results from both studies showed a 34% reduction in
cognitive decline in patients on solanezumab.
As far as the safety profile is concerned, the only adverse
event with an incidence of at least 1% was angina.
The results provide Eli Lilly with the option to develop
solanezumab for the treatment of patients with mild Alzheimer's
disease. Eli Lilly intends to discuss the data with the regulatory
authorities in order to determine the path forward. In our view,
Eli Lilly will be required to conduct additional studies in the
target patient population.
The Alzheimer's disease market has attracted a lot of attention
from several companies.However, the successful development of
therapies for the treatment of Alzheimer's disease is challenging
and we note that several companies have failed in developing
treatments for the same. In fact, Eli Lilly has faced failure
before in this field. The company suffered a major setback in
August 2010 when it had to halt the development of another phase
III Alzheimer's candidate semagacestat (LY450139).
) had shelved its late-stage Alzheimer's candidate, bapineuzumab
IV, after it failed two phase III studies. Pfizer was developing
the candidate in collaboration with
Johnson & Johnson
) has three candidates in phase II development for Alzheimer's
disease, which could be filed for approval after 2016.
The Alzheimer's disease market represents huge commercial
potential and a successfully developed product could generate
billions of dollars in sales once launched. As per data provided by
the National Institute of Neurological Disorders and Stroke,
approximately 5.4 million people have Alzheimer's disease in the US
We currently have a Neutral recommendation on Eli Lilly. The
company carries a Zacks #4 Rank (short-term Sell rating).
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