Amgen will partner with Novartis to co-commercialize erenumab in the U.S. while the Swiss phama giant will exclusively promote the migraine prevention drug in Canada, under a revision of a 2015 collaboration whose value remains undisclosed.
Several components of the original deal between the companies remain in effect. Amgen will retain exclusive commercialization rights in Japan, while Novartis will keep its commercialization rights in the rest of the world, and both companies will continue to collaborate on global co-development of erenumab, also known as AMG 334.
Amgen and Novartis agreed to partner on erenumab in September 2015 as part of a collaboration originally envisioned as involving joint development and commercialization of treatments in Alzheimer's disease as well as migraine.
Erenumab is a fully human monoclonal antibody designed to target and block the calcitonin gene-related peptide (CGRP) receptor, believed to play a critical role in mediating the pain of migraine.
Erenumab is believed to be furthest along among CGRP inhibitors for migraine prevention. The field also includes Eli Lilly’s Phase III candidate galcanezumab (LY2951742), Alder Biopharmaceuticals’ Phase III candidate eptinezumab (also called ALD403), and Teva Pharmaceutical Industries’ Phase IIb candidate TEV-48125.
CGRP inhibitors have been projected to account for $4.5 billion of the total $10 billion-plus market to which the migraine drug market is expected to grow by 2025 in the U.S., France, Germany, Italy, Spain, the U.K., and Japan—up from $3 billion in 2015, according to a Decision Resources Group study published last year.
Last year, erenumab generated positive results in a Phase II study and two Phase III studies assessing the drug in migraine prevention. In the studies, once-monthly subcutaneous 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.
The clinical data will help support discussions with regulatory agencies, with a filing anticipated in the second quarter, Amgen and Novartis said.
Novartis said it expects to begin making milestone payments to Amgen this year. Novartis will share U.S. commercialization costs with Amgen. Amgen will book sales of erenumab in the U.S. and pay royalty payments to Novartis on U.S. net sales, while Novartis will book sales in rest of the world—excluding Japan, where Amgen has that responsibility—and pay Amgen royalties on the net sales in those countries.
Novartis has also agreed to assume remaining global development costs up to a cap, above which it will share global development costs with Amgen.
“Combining the U.S. capabilities of Amgen and Novartis in preparation for the launch of erenumab can create meaningful value over the life of this first-in-class program by enabling us to more effectively, and perhaps even more rapidly, reach people who live with the impact of migraine on a daily basis,” Anthony C. Hooper, Amgen evp of global commercial operations, said in a statement.