AstraZeneca and Eli Lilly and Company announced that AMARANTH, a phase II/III study of AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for early Alzheimer’s disease, will continue into phase III of the phase II/III seamless trial.
The AMARANTH independent data monitoring committee recommended the study continue without modification after a scheduled interim safety analysis was conducted. The analysis was not designed to review efficacy.
Following the latest development, AstraZeneca and Eli Lilly announced the commencement of a new phase III study on AZD3293 – DAYBREAK. The study will evaluate the safety and efficacy of AZD3293 in patients with mild Alzheimer’s dementia. Enrollment of patients will begin in the third quarter of 2016.
The advancement of AZD3293 into phase III development will trigger a milestone payment of $100 million to AstraZeneca from Eli Lilly.
In Sep 2014, AstraZeneca and Eli Lilly had announced an agreement for the development and commercialization of AZD3293. Per the deal, Eli Lilly will lead the development path and will work alongside researchers from AstraZeneca, who will undertake manufacturing responsibilities. Both companies will share development and commercialization costs and net global revenues equally post-launch.
Moreover, AstraZeneca informed that the payment will be reported as Externalisation Revenue in the company’s financial statements and is not expected to impact the financial guidance for 2016.
We are encouraged by the companies’ progress with their Alzheimer’s disease candidate. Per data provided by AstraZeneca in its press release, an estimated 46 million people are living with dementia across the world. Alzheimer’s disease accounts for 60% to 80% of dementia cases.
So, this market offers huge commercial potential and a successfully developed product could bring in billions of dollars in sales. We note that several companies are looking to enter this space including Biogen Inc. BIIB.
However, we note that the successful development of therapies for the treatment of Alzheimer’s disease is challenging with quite a few companies having faced significant setbacks.