Lilly pays AstraZeneca $100m as Alzheimer's drug enters phase 3

AstraZeneca and Eli Lilly are to continue with a pivotal phase 2/3 study of a key pipeline drug, AZD3293 for early Alzheimer's disease, after interim safety data boosted confidence in the drug.

The companies said the AMARANTH trial's data independent data monitoring committee recommended the study continue into phase 3 without modification after a scheduled interim safety analysis.

The analysis was not designed to review efficacy, however, so there are no new signs that the drug might help halt the progress of the disease - a goal that has proven to be elusive for more than a decade.

AZ will receive a milestone payment of $100 million from Lilly, as part of the deal that began in 2014.

AZD3293 is an oral beta secretase cleaving enzyme (BACE) inhibitor shown in phase 1 studies to reduce levels of amyloid beta in the cerebro-spinal fluid of people with Alzheimer's disease and healthy volunteers.

AZ and Lilly added that they are to begin a new phase 3 trial for AZD3293, called DAYBREAK, studying safety and efficacy in people with mild Alzheimer's dementia. DAYBREAK will begin enrolling patients in the third quarter of this year.

In its 2014 long-range plan, AZ forecast the drug could generate sales of up to $5 billion if approved, although it conceded that analysts had predicted sales in the $0.5-$3 billion range. Lilly also has an Alzheimer's drug in phase 3 development, solanezumab.

AZ and Lilly began an alliance in 2014 for the development and commercialisation of AZD3293/LY3314814.

Under the agreement, Lilly leads clinical development, working with researchers from AZ's neuroscience R&D team, while AZ will be responsible for manufacturing.

The companies will take joint responsibility for commercialisation of the molecule and will share all future costs equally for development and commercialisation, as well as net global revenues post launch.

Executive vice president of AZ's IMED Biotech Unit, Menelas Pangalos, said: "BACE inhibitors have the potential to target one of the key drivers of disease progression and we are delighted that our combined efforts have resulted in the development of AZD3293 moving into the next phase of study.

"Disease modifying approaches, such as this, have the potential to transform the treatment of Alzheimer's disease and help patients in this area of large unmet medical need."

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