The companies will focus on developing a medicine that can be given orally, rather than as an injection, through the development of so-called beta-site APP-cleaving enzyme-1 (BACE) inhibitor drugs.
BACE inhibitors work by blocking an enzyme called beta secretase that is involved in the production of beta-amyloid (Ab), a protein that creates brain plaques considered a major cause of AD.
Novartis’s CNP520 will be the lead molecule and further compounds from both company’s pre-clinical BACE inhibitor programmes may be considered as follow-on molecules.
Currently in Phase I/IIa trials, CNP520 is an oral drug designed to prevent the production of different forms of amyloid and has the potential to prevent, slow or delay the symptoms associated with AD.
The collaboration allows Amgen to focus on the commercialisation of its migraine programmes in the US, Canada and Japan, while using Novartis’s commercial capabilities in neuroscience throughout Europe and other markets worldwide.
The companies will also jointly develop and commercialise Amgen’s migraine portfolio, including Phase III AMG 334 and Phase I AMG 301.
For the migraine programme, Novartis will have global co-development rights and commercial rights outside the US, Canada, and Japan.
Novartis Pharmaceuticals head David Epstein said: "This Novartis collaboration with Amgen highlights our clear commitment to neuroscience and to bring multiple, new targeted therapies to patients living with Alzheimer’s disease and migraine, where the unmet medical need remains high."
As part of the deal, Amgen will pay an undisclosed upfront payment and milestone payments, as well as disproportional research and development costs for a period, followed by a 50/50 cost and profit share arrangement.
AMG 334 is a fully human monoclonal antibody that inhibits the activity of calcitonin-gene-related-peptide (CGRP) by targeting its receptor.
CGRP is believed to play a major role in the development of migraines.
AMG 334 is currently under evaluation in several large global, randomised, double-blind, placebo-controlled phase III trials to evaluate its safety and efficacy in migraine prevention.
AMG 301 is a monoclonal antibody currently being investigated in Phase I trials for the prevention of migraine.
Image: Diagram of the brain of a person with Alzheimer’s Disease (right) and of a normal brain (left). Photo: courtesy of ADEAR: ‘Alzheimer’s Disease Education and Referral Center, a service of the National Institute on Aging’.