Eli Lilly and AstraZeneca have announced an agreement to co-develop and commercialise AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for Alzheimer’s disease.
The progression of Alzheimer’s disease is characterised by the accumulation of amyloid plaque in the brain. BACE is an enzyme associated with the development of beta-amyloid. Inhibiting BACE is expected to prevent the formation of amyloid plaque and eventually slow the progression of the disease.
AZD3293 is an oral potent small molecule inhibitor of BACE that has been shown in phase 1 studies to reduce levels of beta-amyloid in the cerebro-spinal fluid of Alzheimer’s patients and healthy volunteers. AstraZeneca announced earlier in 2014 its plan to move AZD3293 into registration trials.
Under the terms of the agreement, Lilly will pay AstraZeneca up to US$500 million in development and regulatory milestone payments. Lilly will recognise the initial milestone of US$50 million (pretax), or approximately US$.03 per share (after-tax), as a charge to earnings in the third quarter of 2014.
AstraZeneca and Lilly aim to progress AZD3293 rapidly into a phase 2/3 clinical trial in patients with early Alzheimer’s disease. Lilly will lead clinical development, working with researchers from AstraZeneca’s Innovative Medicines Unit for neuroscience, while AstraZeneca will be responsible for manufacturing. The companies will take joint responsibility for commercialisation of AZD3293. The companies will share all future costs equally for the development and commercialisation of AZD3293, as well as net global revenues post-launch.