Amgen (NASDAQ: AMGN) today announced a neuroscience collaboration with Novartis in the areas of Alzheimer's disease and migraine. The collaboration accelerates Amgen's potential entry into Alzheimer's disease by teaming up with Novartis on a differentiated and genetically validated Alzheimer's disease program directed at genetically predisposed individuals at risk of developing Alzheimer's disease. The collaboration also enables Amgen to focus on the commercialization of its migraine programs in the U.S., Canada and Japan, while leveraging Novartis' strong commercial capabilities in neuroscience throughout Europe and other markets worldwide.
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 pre-clinical BACE inhibitor programs will be potential follow-ons. Amgen will make upfront and milestone payments, and will be responsible for disproportional research and development (R&D) costs for an agreed-upon period followed by a 50/50 cost and profit share arrangement. CNP520 is planned to be included in a pioneering prevention study, in collaboration with the Banner Alzheimer's Institute. 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.
As part of the collaboration, Novartis receives global co-development rights and commercial rights outside of the U.S., Canada and Japan to the investigative molecules in Amgen's migraine portfolio program. This includes AMG 334 in Phase 3 and AMG 301 in Phase 1, as well as an option to commercialize an additional early-stage Amgen molecule in these territories. In exchange for territory rights, 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.
"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 Research and Development 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."
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