Alzheimer's brain

Amgen and Novartis partner on Alzheimer’s and migraine treatments

pharmafile | September 2, 2015 | News story | Research and Development Alzheimer's disease, Amgen, Novartis, migraine, neurology, neuroscience 

Amgen and Novartis have announced a global collaboration to develop neuroscience treatments in Alzheimer’s disease and migraine. 

The companies plan to co-develop and co-commercialise a BACE inhibitor program for Alzheimer’s, in which Novartis’ oral therapy CNP520 will be the lead molecule. Further compounds from both companies’ pre-clinical BACE inhibitor programs may be considered as follow-ons. 

US-based Amgen and Swiss company Novartis will share responsibilities for development and commercialisation of the BACE inhibitor program, with Amgen paying an upfront fee and milestone payments as well as disproportional early research and development costs, followed by a 50/50 cost and profit-share arrangement. 

It is estimated that around 44 million people globally have Alzheimer’s or a related dementia, with Amyloid build-up considered a key factor in the progressive damage of the nervous system in the disease. CNP520 is designed to prevent the production of different forms of amyloid and has the potential to prevent, slow or delay the symptoms associated with Alzheimer’s. 

CNP520, which is currently in phase I/IIa trials, is planned to be included in a study in people with a genetic risk of developing the condition, conducted by Novartis in collaboration with the Banner Alzheimer’s Institute. 

The collaboration agreement also gives Novartis co-development and commercialisation rights to drugs in Amgen’s migraine portfolio, including Phase III AMG 334 and Phase I AMG 301. For the migraine program, Novartis will have global co-development rights and commercial rights outside the US, Canada, and Japan. 

Migraine is said to affect as many as 10% of the global population. AMG 334 inhibits the activity of Calcitonin-Gene-Related-Peptide (CGRP), which is believed to play a key role in the development of the severe headache condition. 

Novartis will fund disproportional amounts of global R&D expenses for an agreed-upon period on the migraine programs and pay Amgen double-digit royalties on sales. 

Amgen says the collaboration would enable it to focus on the commercialisation of its migraine programs in the US, Canada and Japan, while leveraging Novartis’ “strong commercial capabilities in neuroscience throughout Europe and other markets worldwide.” 

David Epstein, head of Novartis Pharmaceuticals, says the collaboration would help bring “multiple, new targeted therapies to patients living with Alzheimer’s disease and migraine, where the unmet medical need remains high.”  

Joel Levy

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