Novartis, Amgen in Legal Dispute Over Migraine Partnership

Pharmaceutical Technology Editors

Amgen issued a notice of termination of its migraine collaboration agreements with Novartis, against which Novartis filed a lawsuit in response.

On April 4, 2019, Novartis announced a legal dispute with Amgen regarding the companies’ migraine collaboration agreements. On April 2, 2019, Amgen issued a notice of termination of its migraine collaboration agreements with Novartis based on an alleged material breach, which Novartis disputes. To prevent Amgen’s attempt to end the collaboration, Novartis has filed a lawsuit asking a court to confirm that Amgen cannot legally terminate the agreements. The agreements will remain in force until a final and binding court decision is made regarding termination.

The dispute revolves around Amgen’s Aimovig (erenumab), a preventive treatment for migraine. The drug, approved by FDA in May 2018 and by the European Commission in July 2018, is the result of an August 2015 collaboration between Amgen and Novartis to develop and commercialize treatments for migraine and Alzheimer's disease. The collaboration focuses on Amgen’s investigational drugs for migraine, including AMG 301, a human monoclonal antibody that inhibits the pituitary adenylate cyclase-activating polypeptide type 1 (PAC1) receptor. In April 2017, the collaboration was expanded to include co-commercialization of Aimovig in the United States. Amgen retains exclusive commercialization rights for the migraine programs in the US (except for Aimovig) and Japan, and Novartis has exclusive commercialization rights in Europe, Canada, and the rest of world.

Source: Novartis