Years ago, two big drugmakers partnered to bring a new kind of cutting-edge migraine medication to patients.
The collaboration was wildly successful — maybe too successful.
But Novartis isn’t taking it lying down. The drug giant just sued Amgen, alleging that its partner doesn’t have a legitimate reason to end the collaboration. Novartis even accused Amgen of trying to keep all the profits from the migraine drug for itself.
The squabble, now poised to play out in court, comes as their product, Aimovig, leads a new and competitive category of migraine drugs that could be worth as much as $10 billion.
The drugs cost roughly $7,000 a year in the US, and about 210,000 American patients have taken Aimovig so far, with about 20,000 patients outside the US, according to the Novartis complaint.
“In the short time since it has been launched in the US, the product has become a runaway success and the number of patients being treated has vastly exceeded what Amgen and Novartis Pharma projected,” the complaint, which was filed on Thursday, says.
Millions of Americans suffer from migraines, and about 3 million to 7 million have chronic debilitating migraines each month. Though many think of migraines as simply head pain, those who get them also often experience vomiting, dizziness, and sensitivity to lights, smells, and sounds.
A new class of migraine drugs aim to offer relief to those who experience migraines more frequently. Aimovig was the first to get approved in the US, and others quickly followed.
(The companies will work to make sure the disagreement won’t affect patient access, Amgen told Business Insider in a statement.)
A yearslong collaboration, now threatened by a dispute
The collaboration between Novartis and Amgen on Aimovig dates back to 2015.
The origins of their quarrel also started that year, when a unit of Novartis called Sandoz began working with another migraine company, the biotech Alder Biopharmaceuticals. Sandoz was manufacturing the experimental migraine drug ALD403 at a factory in Austria.
Novartis said it found out about the agreement only this past summer and, in the interest of being a good partner, gave Amgen a heads up.
Amgen objected, and the two companies have been going back and forth about it since then. On Tuesday, Amgen gave Novartis notice that it wanted to terminate their collaboration.
Alder’s ALD403 has indeed been positioned as a rival product to Aimovig and other already approved drugs from the generic drugmaker Teva and the pharmaceutical company Eli Lilly. They all use a similar scientific approach to treating migraines preventatively, or before they happen.
Novartis says it risks losing more than $500 million
But in the complaint, which was filed in the Southern District of New York, Novartis said that ALD403 isn’t really a threat to Aimovig.
The experimental drug, which hasn’t been approved anywhere, “differs significantly from, and will not fully compete with, Aimovig,” Novartis’ complaint says. That’s because it will be the fourth type of new migraine product and has to be injected by a doctor at their office, while patients can self-inject Aimovig.
The Swiss drug giant also said it has invested too much in Aimovig to get cut out now, having spent about $530 million to help out with the US launch last May.
Amgen gets the bulk of US sales for Aimovig, which amounted to roughly $120 million last year, and pays royalties to Novartis. Novartis, meanwhile, gets commercial rights outside the US under their agreement.
And while the companies haven’t disclosed how that breaks down, most assume they’re roughly splitting profits, the Mizuho analyst Salim Syed said.
Ending the agreement now would mean doing so “before Novartis Pharma has come close to earning a return on its investment,” Novartis said.
“Amgen’s purpose is all too apparent,” the complaint adds. “On the heels of Aimovig’s successful launch, Amgen wants to cut Novartis Pharma out of the future sales of Aimovig in the U.S.”