Novartis and Amgen have spent years arm wrestling one another over their development and commercialization deal on migraine prevention drug Aimovig. Now, the parties appear ready to drop their dispute and move on.
In a SEC filing Monday, Amgen said the parties were updating the terms of their Aimovig collaboration and settling their dueling lawsuits related to the deal.
In April 2019, Novartis sued Amgen for trying to inappropriately back out of their collaboration on the CGRP migraine prevention drug Aimovig. Amgen originally had rights to the drug, but Novartis in 2015 partnered on the med and spent more than $800 million on its development and commercialization, the lawsuit said.
Amgen responded with its own lawsuit arguing that Novartis breached the deal by helping bring a potential competitor to market. Back in 2015, Novartis' Sandoz unit entered a contract manufacturing partnership with Alder BioPharmaceuticals on a rival CGRP drug then known as eptinezumab. Lundbeck is now marketing that drug as Vyepti after its $2 billion buyout of Alder.
Fast forward to this week, and Amgen said in its filing that the companies are entering a confidential settlement to resolve their lawsuits. A Novartis spokesperson confirmed the news, saying Tuesday that “the parties have agreed to resolve and dismiss all their remaining claims in the litigation."
"This decision, which will end the litigation and help enhance operational efficiencies in the increasingly competitive migraine space, will not have an impact on the distribution of or access to Aimovig,” she added.
Going forward, Amgen will keep U.S. rights to the drug and will no longer pay Novartis royalties on U.S. sales. Amgen will pay all commercialization costs in the U.S., but the companies will continue to share development costs worldwide. Novartis will keep rights to the drug outside of the U.S. and Japan.
The new setup was effective from January 1.
Novartis won’t make any staffing changes as a result of the deal. That comes in contrast to a prior change for the drugmaker on its Aimovig collaboration. Last year, Novartis said it would slash 186 jobs when it handed U.S. rights to the med back to Amgen. Previously, the companies had shared U.S. business responsibilities, including sales, marketing, medical support functions and more.
Aimovig won FDA approval in 2018 as the first in a class of injectable CGRP medicines to prevent migraines. It’s since been joined by several drugs on the market from Eli Lilly, Teva and Lundbeck, and it seems to have lost its early sales edge over some rivals. In the first nine months of 2021, Aimovig pulled in $227 million for Amgen, compared with $416 million for Eli Lilly’s Emgality, $227 million for Teva’s Ajovy and $50 million for Lundbeck’s Vyepti.
Meanwhile, a group of new oral medicines are now threatening the injectable meds. Biohaven’s Nurtec ODT has dual approvals for migraine prevention and treatment, and AbbVie has a pair of new meds that analysts expect to become blockbusters.