Amgen accuses Novartis of breaching their partnership for Aimovig and files lawsuit.

The first CGRP inhibitor for the preventive treatment of migraine approved by the U.S. Food and Drug Administration (2018) –– once-monthly, self-injected Aimovig (erenumab) –– is doing well in the marketplace, but the collaboration between developers Novartis and Amgen is falling apart.

Amgen recently filed a lawsuit against Novartis. Amgen claims that Novartis has breached the partnership for Aimovig and wants to terminate the collaboration, which was established in 2015. Under that agreement, Novartis has co-marketing rights in the United States and global commercial rights, except in Japan. Novartis has responded with its own lawsuit against Amgen, claiming that Amgen is trying to get out of the deal inappropriately in order to retain all of the profits.

The main issue relates to an agreement that Novartis has with Alder Biopharma, which is developing eptinezumab, a competitor CRGP inhibitor that Alder is seeking approval for in the United States, with a possible launch in 2020. Novartis’s Sandoz unit signed an agreement in 2015 to contract manufacture eptinezumab for Alder, an agreement that was recently extended to 2023.

Amgen believes this deal breaches the contract it has with Novartis because Sandoz is helping a competitor to develop, commercialize and manufacture its product. Amgen also says Novartis failed to exit the agreement when asked. Novartis says the contract with Alder is being phased out over the next five years, and regardless — because Sandoz is acting only as a contract manufacturer — there is no conflict of interest.

Aimovig already has competition from Teva’s Ajovy (fremanezumab) and Eli Lilly’s Emgality (galcanezumab). All three are administered once per month via subcutaneous injection. Eptinezumab, on the other hand, is an intravenous drug administered once every three months in the clinical setting. Novartis claims the different administration means it doesn’t “fully compete” with Aimovig.