- Teva Pharmaceutical Industries Limited., (NYSE and TASE:TEVA) today 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.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by approximately 200 million patients in 100 markets every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has the world-leading innovative treatment for multiple sclerosis as well as late-stage development programs for other disorders of the central nervous system, including movement disorders, migraine, pain and neurodegenerative conditions, as well as a broad portfolio of respiratory products. Teva is leveraging its generics and specialty capabilities in order to seek new ways of addressing unmet patient needs by combining drug development with devices, services and technologies. Teva's net revenues in 2016 were $21.9 billion. For more information, visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:
Our ability to defend our intellectual property rights, including our CGRP antibodies patent portfolio;
our specialty medicines business, including: competition for our specialty products, especially Copaxone®, our leading medicine, which faces competition from existing and potential additional generic versions and orally-administered alternatives; our ability to achieve expected results from investments in our product pipeline; competition from companies with greater resources and capabilities; and the effectiveness of our patents, and other measures to protect our intellectual property rights.
our business and operations in general, including: uncertainties relating to the potential success and our ability to effectively execute a restr...
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