Amgen has entered a collaboration with Novartis in the areas of Alzheimer’s disease and migraine using Novartis’ differentiated and genetically validated Alzheimer’s program directed at genetically predisposed individuals at risk. The collaboration also allows Amgen to focus on the commercialization of its migraine programs in the U.S., Canada and Japan, while leveraging Novartis’ commercial capabilities in neuroscience throughout Europe and other markets.
 
The agreement combines each company’s BACE (beta-site APP-cleaving enzyme-1) programs targeting Alzheimer’s disease into a global co-commercialization and co-development arrangement. Novartis’ Phase 1/2a BACE inhibitor (CNP520) will be the lead molecule and each company’s preclinical BACE inhibitor programs will be potential follow-ons.
 
Amgen will make upfront and milestone payments, and will be responsible for disproportional R&D costs for an agreed-upon period followed by a 50/50 cost and profit share arrangement. Amgen was the first company to clone the BACE gene and subsequent genetic validation of the BACE target has been confirmed by Amgen subsidiary deCODE Genetics.
 
Novartis receives global co-development rights and commercial rights outside of the U.S., Canada and Japan to investigative molecules in Amgen’s migraine portfolio. This includes AMG 334 in Phase III and AMG 301 in Phase I, as well as an option to commercialize an additional early-stage Amgen molecule. Novartis will fund disproportional amounts of global R&D expenses for the migraine programs and pay Amgen royalties on sales.
 
“We are very pleased to be joining forces with Novartis on two important neuroscience programs where there remains high unmet medical need,” said Sean E. Harper, M.D., executive vice president of R&D at Amgen. “Our collaboration on BACE inhibition reflects Amgen’s strategic focus on genetically validated drug candidates while our collaboration in migraine creates an opportunity to more rapidly advance AMG 334 on a global scale.”