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
- Withdraw its appeal before the European Patent Office;
- Make an immediate one-time payment of
$25 millionto Teva;
- Make a second one-time payment of
$25 millionupon the approval of a biologics license application (BLA) for eptinezumab with the U.S. Food and Drug Administrationor 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 millionat each of two sales-related milestones (at $1 billionand $2 billionin 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
This press release contains forward-looking statements, including, without limitation, statements relating to: the continued development and clinical, therapeutic and commercial potential of eptinezumab; the commercialization of eptinezumab; and the anticipated benefits to Alder under the referenced settlement and license agreement and the obligations of the parties thereunder. Words such as “will,” “provide,” “clarity,” “freedom,” “deliver,” “potential,” or other similar expressions, identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. The forward-looking statements in this press release are based upon Alder's current plans, assumptions, beliefs, expectations, estimates and projections, and involve substantial risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: risks related to the potential failure of eptinezumab to demonstrate safety and efficacy in clinical testing; Alder's ability to conduct clinical trials and studies of eptinezumab sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of eptinezumab; risks and uncertainties related to regulatory application, review and approval processes and Alder's compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the manufacture of eptinezumab; Alder's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Alder's development and commercialization activities; the sufficiency of Alder's capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption "Risk Factors" in Alder's Quarterly Report on Form 10-Q for the quarterly period ended
Investor Relations Contacts:
Stern Investor Relations, Inc.
Source: Alder BioPharmaceuticals, Inc.