Eli Lilly (LLY - Free Report) recently provided an update on its plans for its Alzheimer’s disease candidate, solanezumab. The company said that based on discussions with regulatory agencies in the US, Europe and Canada, it has decided to study solanezumab in an additional phase III study that will be conducted in patients with mild Alzheimer’s disease.
Eli Lilly is working on fixing the study design, length and other details and expects to commence the study by the third quarter of 2013. While Eli Lilly does not intend to seek US approval based on data from the EXPEDITION studies, it said that it continues to analyze the data with other regulatory agencies.
Eli Lilly’s decision to wait for additional data before filing for US approval does not come as a surprise. Eli Lilly had initially reported top-line data on solanezumab 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 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 results.
The ADCS’ independent analysis of solanezumab was presented at the annual meeting of the American Neurological Association (ANA).
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 solanezumab. 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 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).
Meanwhile, Pfizer (PFE - Free Report) 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 (JNJ - Free Report) and Elan Corporation . Roche (RHHBY - Free Report) 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 a huge commercial potential and a successfully developed product could generate billions of dollars in sales once launched.
We currently have a Neutral recommendation on Eli Lilly, which carries a Zacks #3 Rank (Hold). Meanwhile, companies like Johnson & Johnson and Roche carry a Zacks #2 Rank (Buy).