Eli Lilly & Company (LLY - Free Report) and its Swiss partner AstraZeneca (AZN - Free Report) announced the discontinuation of two late-stage studies on their Alzheimer’s disease (AD) candidate, lanabecestat, on recommendation of the independent data monitoring committee (IDMC).
The IDMC said that the AMARANTH study evaluating lanabecestat in early Alzheimer's disease and the DAYBREAK-ALZ study in mild Alzheimer's disease dementia were unlikely to meet the primary endpoints upon completion, leading to the decision to discontinue the studies on the oral beta secretase cleaving enzyme (BACE) inhibitor. The companies claim that the recommendation to stop the studies was not based on safety concerns.
As Lilly does not expect to incur significant costs related to these discontinuations, it maintained its previously issued 2018 earnings guidance. Meanwhile, the 2014 partnership between Lilly and AstraZeneca to develop a BACE inhibitor remains intact.
Lilly and AstraZeneca are also developing another treatment for Alzheimer's disease, an antibody targeting beta amyloid in early-stage studies.
Year to date, Lilly’s shares have risen 1.7% against the industry’s decline of 3.7%.
This is not the first failure for Lilly in the Alzheimer’s disease market, In November 2016, Lilly’s anti-amyloid candidate solanezumab failed to meet the primary endpoint in a late-stage AD study. Lilly decided to drop the development of solanezumab. Lilly also suffered a major setback in August 2010, when it had to halt the development of another phase III Alzheimer’s candidate, semagacestat.
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, a fatal illness that causes progressive decline in memory, is challenging and we note that several companies have failed in this regard.
In May this year, J&J (JNJ - Free Report) halted development of atabecestat, its investigational BACE inhibitor, which was being developed for preclinical stage Alzheimer’s disease, due to safety concerns.
In February this year, Merck (MRK - Free Report) discontinued the second late-stage study evaluating its BACE inhibitor verubecestat for the treatment of prodromal Alzheimer’s disease as its success was unlikely. In February last year, Merck discontinued a late-stage study evaluating verubecestat for mild-to-moderate Alzheimer’s disease due to lack of efficacy.
In late 2017, Biogen’s Alzheimer’s disease study on BAN2401 failed to show early positive results, which raised investors’ concern about the candidate’s chances of success.
The Alzheimer’s disease market represents huge commercial potential and a successfully developed product could generate billions of dollars in sales once launched.
Lilly currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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