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AZ and Lilly set up BACE camp for Alzheimer's

Lilly will pay AZ up to $500m in development and regulatory costs

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AstraZeneca (AZ) has tapped into the expertise of Eli Lilly to help develop its Alzheimer's disease (AD) candidate AZD3293, currently in early-stage testing.

The compound is an oral beta secretase cleaving enzyme (BACE) inhibitor, the same class as Lilly's LY2886721 compound, which was dropped last year after phase II trials revealed it was linked to liver toxicity.

BACE is one of the enzymes involved in the creation of amyloid plaques in the brain - a hallmark of AD - and it is hoped that inhibiting it might slow the progression of the disease. Other companies developing drugs in the class include Merck & Co - which has reach phase III testing for MK-8931 - Eisai and Novartis, although Roche abandoned its efforts in this area last year.

Under the terms of the agreement Lilly will pay AZ up to $500m in development and regulatory milestones - with the first $50m tranche due next year - and the two companies will share the costs of developing the drug as well as revenues if it reaches the market.

Lilly suffered another setback in AD development after its solanezumab candidate - designed to break down already-formed plaques - failed to show any benefit in a phase III trial reported in 2012.

That and a host of other failures have dented confidence in the entire hypothesis that amyloid is a valid drug target in AD, but the huge and rising number of patients with dementia around the world is encouraging companies to stick with development programmes.

Lilly's solanezumab for example remains in phase III testing in mild AD and healthy, at-risk people to see if dosing the drug earlier can achieve a better outcome.

AZ and Lilly plan to progress AZD3293 rapidly into a phase II/III trial in patients with early-stage AD on the strength of phase I studies which showed the drug dose-dependently reduced levels of amyloid beta in the cerebrospinal fluid (CSF) of both AD patients and healthy volunteers.

Lilly's prior experience with BACE inhibitors means it will lead the AZD3293 clinical development programme with AZ responsible for manufacturing the drug.

Mene Pangalos, AZ's head of innovative medicines and early development, said AD is “one of the biggest challenges facing medical science today and BACE inhibitors have the potential to target one of the key drivers of disease progression."

"By combining the scientific expertise from our two organisations and by sharing the risks and cost of late-stage development, we will be able to accelerate the advancement of AZD3293 and progress a promising new approach," he added.

Article by
Phil Taylor

17th September 2014

From: Research

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