THOUSAND OAKS, Calif.—Amgen and Novartis have launched a neuroscience collaboration focused on Alzheimer's disease and migraine. Both companies' beta-site APP-cleaving enzyme-1 (BACE) programs for Alzheimer's disease are combined in this agreement in a global co-development and co-commercialization deal.
Per the terms of the agreement, Novartis will receive upfront and milestone payments, and Amgen will be responsible for disproportional research and development costs for a set period of time, after which the companies will have a 50/50 cost- and profit-share arrangement. Novartis will gain global co-development rights and commercial rights outside of the United States, Canada and Japan for Amgen's investigational migraine molecules—which includes AMG 301 and AMG 334—as well as an option to commercialize another early-stage Amgen molecule in those territories. In return for those territory rights, Novartis will fund disproportional amounts of global research and development expenses for an agreed-upon period on the migraine programs, in addition to paying Amgen double-digit royalties on sales. No specific financial details were disclosed.
"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," said David Epstein, head of Novartis Pharmaceuticals.
The lead molecule will be CNP520, Novartis' oral Phase 1/2a BACE inhibitor. It is designed to prevent the production of several forms of amyloid and could prevent or delay symptoms associated with Alzheimer's disease. Novartis' and Amgen's preclinical BACE inhibitor programs will be potential follow-ons. CNP520 will be included in a pioneering prevention study in collaboration with the Banner Alzheimer's Institute in individuals with a genetic risk of developing Alzheimer's disease, specifically those who inherited two genetic copies of the apolipoprotein E epsilon 4 (APOE4) allele, which is strongly linked to late-onset Alzheimer's disease.
AMG 334 is a fully human monoclonal antibody being evaluated for the prevention of migraine, specifically by inhibition of the activity of Calcitonin-Gene-Related-Peptide by targeting its receptor. The molecule is under investigation in a number of Phase 3 trials to determine its safety and efficacy. AMG 301, another monoclonal antibody, is being evaluated in Phase 1 trials.
"We are very pleased to be joining forces with Novartis on two important neuroscience programs where there remains high unmet medical need," Dr. Sean E. Harper, executive vice president of Research and Development at Amgen, said in a press release. "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."