Elan is paying Transition Therapeutics a $9 million signing fee as part of an amended agreement for development of the latter’s Phase II-stage Alzheimer disease candidate, ELND005 (Scyllo-inositol).
Under terms of the deal Transition will receive another $11 million when the next clinical trials with ELND005 are initiated, is passing its 30% ownership in the drug over to Elan, and could potentially earn an additional $93 million in regulatory and commercialization milestones.
Transition will in addition receive 8–15% in tiered royalties on sales of the drug. The royalty arrangement means Transition will no longer fund the development and commercialization of ELND005.
ELND005 is a beta amyloid antiaggregation agent, which is undergoing a Phase II evaluation in patients with mild-to-moderate Alzheimer disease. Transition claims preclinical studies showed the drug stopped and/or reversed the progresion of Alzheimer disease pathologies and symptoms by neutralizing Aβ oligomers, preventing the formation of Aβ fibrils, and breaking down existing fibrils.
In August the firms reported topline data from an 18 month Phase II placebo-controlled, dose-ranging study evaluating oral ELND005 in 351 patients with mild-to-moderate Alzheimer disease. Early data suggested that the cognitive and functional co-primary endpoints did not achieve statistical significance. However, the 250 mg twice-daily dose of ELND005 did demonstrate a biological effect on amyloid-beta protein in the cerebrospinal fluid (CSF) of the subgroup of patients who provided CSF samples and showed some effects on clinical endpoints in an exploratory analysis.
The two higher-dose groups were electively discontinued by the companies in December 2009 due to an observed imbalance of serious adverse events including deaths although no causal relationship between the drug and the deaths could be determined. At the time the data was reported Elan and Transition confirmed they were planning to progress ELND005 into Phase III development.
The firms’ original worldwide agreement for the development and commercialization of ELND005 was signed in 2007. Transition received up-front payments of $15 million.