Amgen, Novartis expand mutual work on migraine

Amgen and Novartis have formed a coalition that will be expanded and, as they hope, bring easier launching of a migraine related product, the USA-based company said late Monday. 

The product in question is erenumab, which  is being tested for the prevention of migraine.

The collaboration of the two world leading drugmakers was established two years ago, and it included researching drugs for helping curbe Alzheimer’s, as well as 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,” it was said in a statement issued by Amgen.

Erenumab

Erenumab is a fully human monoclonal antibody specifically designed to target and block the Calcitonin Gene-Related Peptide (CGRP) receptor, believed to have a critical role in mediating the incapacitating pain of migraine. Amgen said that positive data from a Phase 2 study and positive top-line results for two Phase 3 studies 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.

Agreement

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 Amgen. Novartis will assume agreed upon remaining global development costs up to a cap and share global development costs thereafter.

Amgen’s executive Anthony C. Hooper, vice president of Global Commercial Operations said that the U.S. capabilities of Amgen and Novartis can create better value for erenumab by enabling more efficient and rapid reaching to the people who live with the impact of migraine on a daily basis.