Takeda and AC Immune have entered into a worldwide option and licence agreement worth over $2.1bn for an investigational Alzheimer’s disease (AD) drug.
AD is the most common form of dementia, which currently affects about 982,000 people in the UK.
The deal gives Takeda an exclusive option to licence global rights to AC’s ACI-24.060, an active immunotherapy designed to generate a robust antibody response against the toxic forms of amyloid beta believed to drive plaque formation and AD progression.
The candidate is currently being evaluated in the phase 1b/2 ABATE trial of patients with prodromal AD, a potentially progressive stage of the disease characterised by signs of mild cognitive decline, and in adults with Down’s syndrome.
AC will be responsible for completing the study and, following option exercise, Takeda would conduct and fund all further clinical development and be responsible for all global regulatory activities as well as worldwide commercialisation.
In exchange, AC Immune will receive an upfront payment of $100m and will be eligible to receive an option exercise fee and additional milestone payments of up to approximately $2.1bn, as well as tiered royalties on worldwide net sales.
Sarah Sheikh, head, neuroscience therapeutic area unit and head, global development at Takeda, said: “We are excited to partner with AC Immune on this ground-breaking treatment approach, which leverages novel technology with the potential to offer patients a treatment with differentiated efficacy, safety and ease of administration.
“Combining AC Immune’s deep experience with active immunotherapy approaches with Takeda’s expertise in neuroscience drug development and commercialisation, we have an incredible opportunity to deliver real impact to the Alzheimer’s community.”
The deal comes just under a year after the US Food and Drug Administration granted fast track designation to ACI-24.060 based on initial interim safety and immunogenicity results from a low dose cohort of ABATE.
AC Immune’s chief executive officer, Andrea Pfeifer, said: “… we are developing an innovative approach that could change the treatment paradigm for AD and address the multifaceted burden that patients and the broader community face.
“We believe the maximum impact of ACI-24.060 can best be realised by partnering with Takeda at this critical juncture in its development, which will help us move rapidly into phase 3.”