Teva Pharmaceutical Industries Ltd. announced that its subsidiary, Teva Pharmaceuticals International GmbH., has signed a global license agreement with Alder BioPharmaceuticals. The agreement validates Teva’s IP and resolves Alder’s opposition to Teva’s European Patent No. 1957106 B1, with respect to anti-calcitonin gene-related peptide (CGRP) antibodies and methods for their use. It also provides Alder with clarity for its ongoing plans in the field.

Under the terms of the agreement, Alder has received a non-exclusive license to Teva’s anti-CGRP antibodies 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 Alder’s eptinezumab with the U.S. Food and Drug Administration or of an earlier equivalent filing with a regulatory authority elsewhere in the license territory in which any Teva licensed patents exist;

Following commercial launch of eptinezumab, pay $75 million at each of two sales-related milestones (at $1 billion and $2 billion in sales achieved in a calendar year) and provide certain royalty payments on net sales at rates from 5% to 7%.

“This agreement reinforces the broad coverage provided by Teva’s IP in the field of anti-CGRP antibodies therapy. At the same time, it also helps facilitate the ongoing development of additional potential therapies in this exciting field – this can only be good for our increased understanding of the area and ultimately improved patient wellbeing”, said Marcelo Bigal, M.D., Ph.D., Chief Scientific Officer and Head of Specialty R&D at Teva.