Novartis sues as Amgen tries to cancel migraine tie-up

Novartis and Amgen have become embroiled in a legal row over rights to the migraine prevention drug Aimovig, as sales of a new class of injected drugs begin to mount.

Amgen’s Aimovig (erenumab), was already close to the end of its clinical development process two years ago this month when Novartis expanded a marketing agreement over the drug, building on a neurology pact dating back to 2015.

Aimovig was approved in the US last May and under the agreement, Novartis co-markets the drug in the US, and markets the drug exclusively in Canada and the rest of the world, except for Japan, where Amgen still has rights.

It’s this deal that Amgen wants to walk away from, sparking a legal dispute between the US pharma and Novartis that looks set to run and run.

Amgen has said Aimovig’s launch has been a huge success, with sales of $95 million in Q4 alone.

In the case filed in a US District Court in Manhattan, Novartis said it is disputing a notice of termination served by Amgen, that seeks to tear up the agreement based on an alleged material breach of the terms of the collaboration.

According to press reports, Amgen is unhappy that Novartis’ subsidiary Sandoz is supplying materials to Alder Biopharmaceuticals, which is developing a rival calcitonin gene-related peptide (CGRP) class migraine that has yet to reach the market.

Novartis has stated that the agreement with Alder is being terminated and the contract manufacturing agreement will only continue until the end of 2023 under an amendment agreed earlier this year.

The Swiss pharma said in a statement: “Novartis has brought a unique and established neuroscience footprint and expertise to the collaboration and has also made significant financial investments in the development and worldwide commercialisation of Aimovig, a preventive treatment for migraine.”

The Swiss pharma reassured patients that their drug supplies will not be affected.

Aimovig was the first CGRP drug approved, and since then Eli Lilly’s Emgality (galcanezumab) and Teva’s Ajovy (fremanezumab) from the same class have already hit the market.

This leads Alder’s eptinezumab as the last of the gang of four CGRP drugs to reach the market, and the biotech based in Bothell, Washington State, filed a dossier with the FDA asking for approval last month. The company is gearing up for a launch in Q1 next year if the FDA’s decision is favourable.

Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.