Eli Lilly and Company
(
LLY
) recently announced much awaited top-line results on Alzheimer's
disease candidate, solanezumab (LY2062430). Eli Lilly said that
solanezumab failed to meet its primary endpoints in both the phase
III EXPEDITION studies. However, the candidate demonstrated
promising potential in slowing cognitive decline.
The identical multi-center, randomized, double-blind,
placebo-controlled EXPEDITION studies (EXPEDITION1 and EXPEDITION
2) enrolled more than 2,050 patients suffering from
mild-to-moderate Alzheimer's disease. Results showed that
solanezumab failed to achieve the primary endpoints namely change
in cognitive and functional performance compared to placebo.
The company plans to discuss the data with the US Food and Drug
Administration (FDA) to determine the future developmental path for
solanezumab. The Alzheimer's Disease Cooperative Study (ADCS) is
conducting an independent analysis of the EXPEDITION study results,
which will be presented at various upcoming scientific meetings in
October 2012. An open-label extension study, EXPEDITION-EXT, is
ongoing.
Our Take
Solanezumab has always been a high risk-return candidate for Eli
Lilly. While disappointed with the phase III results, solanezumab's
failure did not come as a major surprise as chances of success were
pretty low.
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).
A few weeks earlier,
Pfizer, Inc.
(
PFE
) had shelved its late-stage Alzheimer's candidate, bapineuzumab,
after it failed two phase III studies. Pfizer was developing the
candidate in collaboration with
Johnson & Johnson
(
JNJ
) and
Elan Corporation
(
ELN
).
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
Alzheimer's Association, approximately 5.4 million people have
Alzheimer's disease in the US alone.
We currently have a Neutral recommendation on Eli Lilly. The
company carries a Zacks #2 Rank (short-term Buy rating).
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