Teva and AlderBiopharmaceuticals have entered into a European patent settlement and global license agreement with Teva Pharmaceuticals International GmbH, the new subsidiary of Teva Pharmaceutical Industries.
The agreement resolves Alder’s appeal following opposition proceedings before the European Patent Office related to Teva’s European Patent 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 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 and immediately pay $25 million to Teva. Furthermore, Teva said in the press release from earlier this week that Alder will make a second one-time payment of $25 million upon the approval of a biologics license application (BLA) for its eptinezumab with the U.S. FDA or of an earlier equivalent filing with a regulatory authority elsewhere in the license territory in which any Teva licensed patents exist. Also, following the 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 solidifies Alder’s freedom to operate and provides a clear path for us to commercialize eptinezumab and, if approved, deliver this potential treatment option to the many patients suffering from migraine,” said Randall C. Schatzman, Alder president and chief executive officer.
“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, Chief Scientific Officer and Head of Specialty R&D at Teva.
Image: A building belonging to Teva Pharmaceutical Industries, the world’s biggest generic drugmaker and Israel’s largest company, is seen in Jerusalem February 8, 2017. REUTERS/Ronen Zvulun