Novartis, Amgen Dispute over Migraine Drug Pact, Including Potential Blockbuster Aimovig

By Patricia Van Arnum - DCAT Editorial Director

April 11, 2019

Novartis reports that it has a legal dispute with Amgen regarding the companies’ collaboration agreements in the field of migraine. On April 2, 2019, Amgen issued a notice of termination of its migraine collaboration agreements with Novartis based on an alleged material breach of the collaboration agreements. Novartis is disputing the notice.

”Novartis considers the notice of termination unjustified and without legal merit,” said Novartis in an April 4, 2019 statement. Novartis said that “in order to prevent an unjustifiable attempt by Amgen to end the collaboration,” it has filed a lawsuit asking the court to confirm that Amgen has no right to terminate the agreements. Novartis says that the agreements will remain in force unless and until a final and binding court decision is pronounced that terminates the agreements.

Amgen and Novartis formed a neuroscience collaboration in 2015 to develop and commercialize treatments in the field of migraine and Alzheimer's disease. The collaboration focuses on investigational Amgen drugs in the migraine field, which included Aimovig (erenumab), which was approved by the US Food and Drug Administration in 2018 for the preventive treatment of migraine in adults, and AMG 301, another migraine drug candidate. In April 2017, the collaboration was expanded to include co-commercialization of Aimovig in the US. For the migraine program, Amgen retains exclusive commercialization rights in Japan, and Novartis has exclusive commercialization rights in Europe, Canada and rest of world.

Some analysts project blockbuster status for Aimovig with projected 2022 sales of $1.170 billion, according to Clarivate Analytics’ Drugs to Watch for 2018 report. It is one of several calcitonin gene-related peptide (CGRP) receptor inhibitors expected to enter the market over the next several years. CGRP, a neuropeptide, has been shown to be released during migraine attacks and may play a causative role in induction of migraine attacks, according to the report.

Source: Novartis