Pharma Focus Asia

Novartis expands global collaboration with Amgen to commercialize first-in-class AMG 334 (erenumab)

Tuesday, April 25, 2017

Novartis today announced an expanded commercialization agreement with Amgen for AMG 334 (erenumab), which is being investigated for the prevention of migraine. This agreement builds on a 2015 global collaboration between Novartis and Amgen, and leverages almost 70 years of Novartis experience in neuroscience to more effectively reach people with migraine. Novartis and Amgen will co-commercialize AMG 334 (erenumab) in the U.S. Novartis will retain exclusive rights to commercialize the drug in rest of world and will gain commercialization rights in Canada. Amgen retains exclusive commercialization rights in Japan. The companies will continue global co-development.

AMG 334 (erenumab) is a fully human monoclonal antibody specifically designed for the prevention of migraine. It targets and blocks the Calcitonin Gene-Related Peptide (CGRP) receptor, believed to play a critical role in mediating the incapacitating pain of migraine. Positive results from a Phase II study and two Phase III studies of AMG 334 (erenumab) in migraine prevention were announced in 2016. In these studies, once-monthly subcutaneous AMG 334 (erenumab) significantly reduced monthly migraine days versus placebo and demonstrated a safety profile comparable to placebo. Detailed results from the Phase III studies are being 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.

"Migraine is a debilitating neurological disease associated with significant personal, economic, and societal burden. There is an urgent need for effective and well-tolerated preventive treatments that positively impact the lives of people with migraine," said Paul Hudson, Chief Executive Officer, Novartis Pharmaceuticals. "We are excited to expand our collaboration with Amgen. We look forward to combining capabilities and leveraging our strong heritage in neuroscience in the U.S. and Canada to bring erenumab to more patients in need, as fast as we can."

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 AMG 334 (erenumab) in the U.S., and will pay a royalty to Novartis on net sales in the U.S. Novartis will book sales in 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.

The agreement is an expansion of a global collaboration with Amgen announced in August 2015 in neuroscience, involving joint development and commercialization of pioneering treatments in the field of Alzheimer's disease and migraine.

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