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Agreements

Date: 2017-04-24

Type of information: Commercialisation agreement

Compound: AMG 334 (erenumab), AMG 301, BACE inhibitor program including CNP520

Company: Amgen (USA - CA) Novartis (Switzerland)

Therapeutic area: CNS diseases - Neurological diseases - Neurodegenerative diseases

Type agreement: development licensing commercialisation

Action mechanism: monoclonal antibody/enzyme inhibitor/BACE (beta-site APP-cleaving enzyme-1) inhibitor. CNP520 is a BACE (beta-site APP-cleaving enzyme-1) inhibitor. This oral drug has been 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 disease. It is currently in Phase 1/2a trials. BACE (beta-site APP-cleaving enzyme-1) initiates the production of beta amyloid (Ab), the primary constituent of amyloid plaques that are believed to play a key role in the etiology of Alzheimer\'s disease. It is hypothesized that inhibiting BACE could reduce the production of amyloid plaques. Amgen was the first to clone and characterize BACE in a 1999 Science publication. Amgen subsidiary deCODE Genetics subsequently added corroborating human genetic evidence of its link to Alzheimer\'s disease in a 2012 Nature publication. AMG 334 (erenumab) is a fully human monoclonal antibody under investigation for the prevention of migraine. AMG 334 inhibits the activity of Calcitonin-Gene-Related-Peptide (CGRP) by targeting its receptor. CGRP is believed to play a key role in the development of migraine. AMG 334 is currently under evaluation in several large global, randomized, double-blind, placebo-controlled phase III trials to assess its safety and efficacy in migraine prevention. In addition to AMG 334, the migraine portfolio will include the development of AMG 301 and potentially another investigational compound of Amgen. AMG 301 is a monoclonal antibody being investigated in phase I trials for the prevention of migraine.

Disease: Alzheimer\'s disease, migraine

Details:

  • • On September 1, 2015 , Novartis and Amgen announced that they have entered into a global collaboration to commercialize and develop pioneering neuroscience treatments. 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 companies will partner in the development and commercialization of a BACE (beta-site APP-cleaving enzyme-1) inhibitor program in Alzheimer\'s Disease (AD). Novartis\' oral therapy CNP520 will be the lead molecule and further compounds from both company\'s pre-clinical BACE inhibitor programs may be considered as follow-on molecules. 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. 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. It is currently in phase I/IIa trials.  .
  • The collaboration will also focus on new Amgen drugs in the migraine field, 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 U.S., Canada, and Japan.Migraine is a severe headache condition affecting more than 10% of the population worldwide and a leading cause of disability. AMG 334 is a fully human monoclonal antibody under investigation for the prevention of migraine. AMG 334 inhibits the activity of Calcitonin-Gene-Related-Peptide (CGRP) by targeting its receptor. CGRP is believed to play a key role in the development of migraine. AMG 334 is currently under evaluation in several large global, randomized, double-blind, placebo-controlled phase III trials to assess its safety and efficacy in migraine prevention. In addition to AMG 334, the migraine portfolio will include the development of AMG 301 and potentially another investigational compound of Amgen. AMG 301 is a monoclonal antibody being investigated in phase I trials for the prevention of migraine.
 

Financial terms: Under the terms of the arrangement, Novartis and Amgen will share responsibilities for development and commercialization of the BACE inhibitor program. Amgen will pay an upfront payment and milestone payments as well as disproportional research and development costs for an agreed upon period followed by a 50/50 cost and profit share arrangement. For the compounds in the migraine field, Novartis receives global co-development rights and commercial rights outside the U.S., Canada and Japan to the 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 in these territories. Novartis will fund disproportional global R&D expenses for an agreed period on the migraine programs and will pay Amgen double-digit royalties on sales.

Latest news:

  • • On April 24, 2017, Amgen announced an expanded commercial collaboration with Novartis for erenumab, which is being investigated for the prevention of migraine. This expanded commercial collaboration builds on a global neuroscience collaboration in Alzheimer's disease and migraine established in 2015 between Novartis and Amgen . This expanded collaboration leverages Novartis' presence in neuroscience to more effectively reach people with migraine.
  • The companies have agreed to combine capabilities to co-commercialize erenumab in the U.S. Amgen retains exclusive commercialization rights in Japan . Novartis gains exclusive rights to commercialize erenumab in Canada , and retains its existing commercialization rights in rest of the world. The companies will continue global co-development.
  • Positive data from a Phase 2 study and positive top-line results for two Phase 3 studies  (Arise study and Strive study) in migraine prevention were announced in 2016. Detailed results from the Phase 3 studies will be presented at the annual meeting of the American Academy of Neurology and submitted for publication. These data will help support discussions with regulatory agencies, with filing anticipated in the second quarter of 2017.
  • Under the terms of the agreement, Amgen will receive milestone payments from Novartis expected to begin in 2017. Novartis will share U.S. commercialization costs with Amgen . Amgen will book sales of erenumab in the U.S., and will pay a royalty to Novartis on net sales in the U.S. Novartis will book sales in the rest of the world, excluding Japan , and will pay Amgen royalties on the net sales in those countries. Amgen will book sales in Japan , since it will remain an exclusive territory for the Company. Novartis will assume agreed upon remaining global development costs up to a cap and share global development costs thereafter.

Is general: Yes