Alder Pharma and Teva enter patent settlement relating to eptinezumab treatment for migraine.
Alder BioPharmaceuticals, Inc.announced that it has entered into a European patent settlement and global license agreement with Teva Pharmaceuticals International GmbH. The agreement resolves Alder�s appeal following opposition proceedings before the European Patent Office related to Teva�s European Patent No. 1957106 B1, with respect to calcitonin gene-related peptide (CGRP) antagonist antibodies, and provides clarity regarding Alder�s freedom to develop, manufacture and commercialize eptinezumab, its lead product candidate for migraine prevention targeting CGRP.
Under the terms of the agreement, Alder has received a non-exclusive license to Teva�s CGRP patent portfolio to develop, manufacture and commercialize eptinezumab in the U.S. and worldwide, excluding Japan and Korea. In exchange, Alder has agreed to: Withdraw its appeal before the European Patent Office; Make an immediate one-time payment of $25 million to Teva; Make a second one-time payment of $25 million upon the approval of a biologics license application (BLA) for eptinezumab with the FDA or of an earlier equivalent filing with a regulatory authority elsewhere in the license territory in which any Teva licensed patents exist; and Following commercial launch of eptinezumab, pay $75 million at each of two sales-related milestones (at $1 billion and $2 billion in annual sales) and provide certain royalty payments on net sales at rates from 5% to 7%.