April 4, 2019 / 3:38 PM / in a month

Novartis, Amgen in dispute over migraine drug partnership

NEW YORK/LOS ANGELES (Reuters) - Swiss drugmaker Novartis AG sued Amgen Inc on Thursday, accusing the U.S. biotechnology company of trying to wrongfully back out of agreements to jointly develop and market the migraine prevention drug Aimovig and keep the profits for itself.

FILE PHOTO: The logo of Swiss drugmaker Novartis AG is seen at its headquarters in Basel, Switzerland January 25, 2017. REUTERS/Arnd Wiegmann

The complaint filed in the U.S. District Court in Manhattan comes as drugmakers move to build share in the large market for new treatments to prevent migraine headaches.

Aimovig, which won U.S. and European approvals last year, belongs to a new class of medicines that also includes Eli Lilly and Co’s Emgality and Teva Pharmaceutical Industries Ltd’s Ajovy.

Novartis called Aimovig a “runaway success,” used by about 210,000 patients in the United States and 20,000 elsewhere.

Roughly 39 million Americans suffer from migraine headaches, according to the Migraine Research Foundation. Global drug sales to treat migraines could total $8.7 billion by 2026, according to the GlobalData analytics firm.

Amgen, in an emailed statement, said it is seeking to terminate the collaboration agreements with Novartis and obtain damages, but termination would not be effective until the litigation is resolved. 

In its complaint, Novartis said it has spent at least $870 million on Aimovig since it began collaborating in August 2015 with Amgen, which previously controlled rights to the drug.

Novartis accused Amgen of trying to back out of their collaboration agreements based on the pretext that the Swiss company’s Sandoz unit was working with Alder Biopharmaceuticals Inc on a possible Aimovig rival.

“The program about which Amgen has complained is being terminated,” Novartis said, and the lack of a breach means Amgen’s April 2 notice terminating the collaboration agreements should be deemed void.

Novartis said that Sandoz this year amended its contract manufacturing agreement with Alder, agreeing to continue supplying Alder’s drug only through 2023.

“Amgen now wants to keep the Aimovig profits for itself and deprive Novartis Pharma of its contractual right to share in the product’s success and recoup its significant investments,” Novartis said.

The lawsuit seeks to enforce the companies’ collaboration agreements and declare Amgen’s purported termination void.

Alder said it is not a party to the pending litigation between Novartis and Amgen. “Sandoz is a separate entity who does contract manufacturing for many companies who would compete with an Amgen or whatever,” Alder Chief Executive Robert Azelby told Reuters in a telephone interview.

RBC Capital Markets analyst Brian Abrahams said in a research note: “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.”

FILE PHOTO: An Amgen sign is seen at the company's office in South San Francisco, California in this October 21, 2013. REUTERS/Robert Galbraith/Files/File Photo

Azelby said Alder intends to keep all U.S. marketing rights for eptinezumab migraine treatment, but is looking for a partner to sell it in other parts of the world.

Novartis’ U.S.-listed shares fell 0.8 percent to close at $94.22, while Amgen shares dropped 0.6 percent, closing at $192.33. Alder’s shares fell 4.9 percent to close at $13.33.

The case is Novartis Pharma AG v. Amgen Inc, U.S. District Court, Southern District of New York, No. 19-02993.

Reporting by Deena Beasley in Los Angeles, Jonathan Stempel in New York, and John Miller in Zurich; editing by Bill Berkrot and Dan Grebler

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