Alder Bio in big patent, license deal with Teva

Bothell, Washington-based Alder BioPharmaceuticals, Inc. said it entered into a European patent settlement and global license agreement with Teva Pharmaceuticals International GmbH.

Alder is focused on developing novel therapeutic antibodies for the treatment of migraine.

“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,” said Alder.

Under 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 US 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 US 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 annual sales — 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 Alder CEO Randall Schatzman.

Alder also announced it entered into a definitive preferred stock purchase agreement with certain institutional and other accredited investors affiliated with or managed by Redmile Group LLC.

“Under the terms of the agreement, the investors have committed to purchase up to $250 million of non-voting Class A Preferred Stock during the three-year term of the agreement, with an initial purchase of $100 million of Class A Preferred Stock,” said Alder.

“Purchases are subject to the satisfaction of customary closing conditions. Each share of Class A Preferred Stock is convertible into ten shares of Alder’s common stock upon certain conditions.

“Alder intends to use the net proceeds from the financing to fund payments under Alder’s European patent settlement and global license agreement with Teva Pharmaceuticals International GmbH announced today, eptinezumab infusion commercialization-readiness activities, and for working capital and general corporate purposes.”