H for headache:

What a Headache! Amgen and Novartis Duel Over Migraine Drug Aimovig

Published: Apr 05, 2019 By Mark Terry

In May 2018, the U.S. Food and Drug Administration (FDA) approved Aimovig (erenumab-aooe) for the prevention of migraine headaches. The drug was commercialized in a partnership between Novartis and Amgen. A 2015 deal gave Novartis co-marketing rights in the U.S. in addition to commercial rights everywhere else except Japan.

Amgen is suing Novartis, alleging a breach of the partnership and seeking to terminate the 2015 contract. Novartis, in response, filed a lawsuit accusing Amgen of inappropriately attempting to end the alliance. In its suit, Novartis claims it has spent “hundreds of millions of dollars” on the partnership since it was signed and that Amgen is attempting “to keep the Aimovig profits for itself and deprive [Novartis] of its contractual right to share in the product’s success and recoup its significant investments.”

In the complaint, Novartis indicates it has invested at least $870 million in Aimovig since the collaboration began in August 2015.

At the heart of the problem is a deal between Novartis and Alder Biopharma. Alder is developing a competitive CGRP inhibitor for migraine called eptinezumab. It was recently submitted for approval to the FDA and could potentially launch in the first quarter of 2020.

Novartis inked a contract manufacturing deal with Alder by way of its Sandoz subsidiary to manufacture eptinezumab. This dates back to 2015 but was recently extended to 2023.

Amgen is arguing that the Novartis-Alder deal is a breach of contract because Sandoz is helping to “develop, commercialize, and manufacture” eptinezumab. It also alleges that Novartis refused to terminate the agreement when requested and has signed on to “future manufacture of the competing product.”

Novartis argues that the contract is being phased out over the next five years. It further argues that Sandoz’ position as a contract manufacturer is not a conflict of interest. “The immaterial contract manufacturing services being provided by an entity that is part of a separate division from Novartis Pharma are not ‘distracting’ Novartis Pharma from developing and commercializing Aimovig,” the lawsuit states.

Aimovig is one of Amgen’s most successful launches, hitting $22 million in its fourth quarter of 2018. Novartis calls it a “runaway success,” and is being used by approximately 210,000 patients in the U.S. and 20,000 people elsewhere. It was the first CGRP inhibitor to hit the market, although it was followed by Teva Pharmaceutical’s Ajovy (fremanezumab) and Eli Lilly’s Emgality (galcanezumab). These drugs are all given by subcutaneous injections

Eptinezumab, if approved, would be administered intravenously in a clinic once every three months.

As a result of that distinction, Novartis is further arguing that it will not “fully compete” with Amgen’s Aimovig.

Robert Azelby, chief executive officer of Alder, told Reuters, “Sandoz is a separate entity who does contract manufacturing for many companies who would compete with an Amgen or whatever.”

In a note to clients, RBC Capital Markets analyst Brian Abrahams, wrote, “We see it as highly unlikely that Sandoz would breach its own agreement with Alder, and in such a case would owe Alder substantial compensation.”

Azelby indicates that Alder plans to retain all U.S. marketing rights for eptinezumab but is seeking a partner to market the migraine drug to the rest of the world.

The complaint was filed in Manhattan federal court. It is Novartis Pharma AG v. Amgen Inc, U.S. District Court, Southern District of New York, No. 19-02993.

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