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Agreements

Date: 2016-12-09

Type of information: Development agreement

Compound: AZD3293, MEDI1814

Company: AstraZeneca (UK) Eli Lilly (USA - IN)

Therapeutic area: Neurodegenerative diseases

Type agreement: development - commercialisation

Action mechanism:

  • BACE (beta-site APP-cleaving enzyme-1) inhibitor. AZD3293 is an oral beta secretase cleaving enzyme (BACE) inhibitor. BACE is an enzyme associated with the development of amyloid beta. Inhibiting BACE is expected to prevent the formation of amyloid plaque and eventually slow the progression of the disease. AZD3293 is an oral, potent and selective small molecule inhibitor of BACE that has been shown in Phase I studies to significantly and dose-dependently reduce levels of amyloid beta in the cerebro-spinal fluid of Alzheimer’s patients and healthy volunteers.
  • MEDI1814  is an anti-amyloid beta monoclonal antibody. The build-up of plaques in the brain containing the peptide amyloid-beta (A?) is one of the characteristics of AD. MEDI1814 binds selectively to A?42, a form of A? which is particularly associated with the disease. Binding dose-dependently reduces levels of this peptide, potentially slowing the progression of Alzheimer’s disease.

Disease: Alzheimer’s disease

Details:

  • • On September 16, 2014, AstraZeneca and Eli Lilly announced an agreement to jointly develop and commercialise AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for Alzheimer’s disease. AstraZeneca and Lilly aim to progress AZD3293 rapidly into a Phase II/III 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.

Financial terms:

  • Under the terms of the agreement, Lilly will pay AstraZeneca up to $500 million in development and regulatory milestone payments. AstraZeneca expects to receive the first milestone payment of $50 million in the first half of 2015. The companies will share all future costs equally for the development and commercialisation of AZD3293, as well as net global revenues post-launch.

Latest news:

  • • On December 9, 2016, Eli Lilly and AstraZeneca announced a worldwide agreement to co-develop MEDI1814, an antibody selective for amyloid-beta 42 (A?42), which is currently in Phase 1 trials as a potential disease-modifying treatment for Alzheimer's disease . This agreement builds on the existing collaboration related to AZD3293, a BACE inhibitor in two pivotal Phase 3 trials.
  • Under the terms of the new agreement, Lilly will make a $30 million upfront payment to AstraZeneca. Lilly will recognize the upfront of $30 million (pretax), or approximately $0.02 per share (after-tax), as a charge to earnings in the fourth quarter of 2016.

Is general: Yes