- Amgen and Novartis are at legal odds in their partnership to market the migraine drug Aimovig, suing each other in federal court Thursday over Novartis' earlier decision to enter into a manufacturing contract with Alder BioPharmaceuticals, which is developing a potential rival to Aimovig.
- As Amgen tells it, Novartis' agreement with Alder violates the contract the two companies signed in 2015 to co-develop and co-commercialize Aimovig in the U.S. In its complaint filed in U.S. District Court for the Southern District of New York, Novartis accused Amgen of attempting to back out of their partnership and keep all the profits from the drug's sales, according to Reuters, which first reported the news.
- Amgen confirmed the dispute in a statement to BioPharma Dive, saying it is seeking to terminate the collaboration agreements with Novartis and obtain damages. Aimovig is one of three similar preventive migraine drugs that gained U.S. approval last year to expectations of blockbuster sales.
Amgen and Novartis are only a year into a first-to-market launch for Aimovig (erenumab), but the big pharma partnership is already showing signs of strain.
The dispute stems from a contract between Sandoz, a Novartis subsidiary, and Alder concerning manufacturing of eptinezumab, the biotech's experimental migraine prevention drug. If approved, eptinezumab would be a direct competitor to Amgen and Novartis' Aimovig.
Novartis, which earns a "significant" royalty of Amgen sales of Aimovig in the U.S., moved first, pre-empting Amgen's own complaint with a lawsuit filed in Manhattan federal court.
Novartis informed Amgen of the agreement in September 2018, but when Amgen pressed the Swiss pharma to resolve the alleged breach of contract, Novartis instead extended its deal with Alder to produce eptinezumab.
As a result, Amgen sought this week to terminate the partnership on Aimovig — a move Novartis is now suing to prevent.
"Novartis disputes the notice vigorously," the Swiss drugmaker said in a statement. "In order to prevent an unjustifiable attempt by Amgen to end the collaboration, Novartis has filed a lawsuit asking the court to confirm that Amgen has no right to terminate the agreements."
In its suit, Novartis calls Aimovig's launch a "runaway success," according to Reuters. While Aimovig is not yet the blockbuster some expect it to become, the drug currently leads competitors from Eli Lilly and Teva in market share and earned $119 million in its first three quarters on the U.S. market.
More than 165,000 patients have taken the drug globally since its approvals, according to the latest estimate from Novartis.
If Amgen is successful in its suit, Novartis could lose access to a drug that's pegged to earn as much as $1.5 billion in peak sales. Significant investment is also at stake: the Swiss pharma has paid some $160 million in R&D costs to Amgen over the past four years, as well as at least $355 million in milestone payments.
In an emailed statement, Amgen said termination of the companies' partnership would not take effect until litigation is resolved.
"The Companies' collaboration agreements remain firmly in place while this dispute proceeds," a spokesperson for Amgen said. Novartis indicated the same in its statement.
Novartis and Amgen are already engaged in another legal battle over patents held by Amgen on its top-selling biologic drug Enbrel (etanercept).
Novartis' involvement with Alder's development of eptinezumab is an interesting twist. The drug works in a similar fashion to Aimovig, although it's given by intravenous infusion rather than via an injection.
The drug is currently under review by the Food and Drug Administration, and Alder expects a launch by the first quarter of 2020.
Shares in Alder fell nearly 5% Thursday on the news. Shares in Amgen and Novartis were little moved.