Teva and Alder sign deal to overcome antibodies dispute
Israel-based Teva Pharmaceuticals has signed a global licence agreement with Alder BioPharmaceuticals.
The partnership comes following US-based Alder’s opposition to Teva’s European patent number 1957106 B1, which covers anti-calcitonin gene-related peptide (CGRP) antibodies and methods for their use.
This collaboration will give Alder the ability to access Teva’s anti-CGRP antibodies patent portfolio. The non-exclusive licence allows Alder to develop, manufacture and commercialise eptinezumab worldwide, excluding Japan and Korea.
According to Alder, CGRP is believed to play a key role in mediating and initiating migraines. Eptinezumab is an experimental drug that prevents the illness by targeting CGRP.
“This agreement reinforces the broad coverage provided by Teva’s IP in the field of anti-CGRP antibodies therapy,” commented Marcelo Bigal, chief scientific officer and head of speciality research and development at Teva.
“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.”
Under the licence agreement, Alder will withdraw an opposition it made before the European Patent Office. Alder will also make an immediate one-time payment of $25 million to Teva.
Should Alder’s eptinezumab be approved for a biologics licence application with the US Food and Drug Administration—or from an earlier equivalent filing—then it will pay Teva a second fee of $25 million.
Following the commercial launch of eptinezumab, Alder will pay Teva $75 million first when the drug reaches $1 billion in sales, and another sum of $75 million when it achieves $2 billion in sales in a calendar year. Certain royalty payments on net sales at rates from 5% to 7% will also be paid.
Randall Schatzman, president and CEO of Alder, commented that data from the eptinezumab trial so far has demonstrated the drug’s deliverance of quick and sustained migraine relief, and that “we remain on track to submit our biologics licence application in the second half of 2018”.
“If approved, eptinezumab has the potential to advance the treatment paradigm in chronic migraine prevention and be a meaningful treatment option for millions of the most severely impacted patients.”
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