A struggling Teva has pulled out of a CGRP migraine drug discovery and development pact with the G protein coupled receptor experts at Sosei, just as the lead candidate looks ready to start clinical development.
That returns the worldwide rights to HTL0022562 to Sosei’s UK subsidiary Heptares Therapeutics, which plans to review the programs before updating the time frame of the drug’s entry into Phase I clinical trials, originally expected in late 2018. Teva — which attributed the move today to its ongoing reprioritization effort on the pipeline — is also handing over all the preclinical data it generated, as well as all licensing rights relating to any CGRP antagonist programs covered by the initial agreement.
The ex-partners inked the agreement back in 2015, laying down $10 million upfront and $400 million in milestones. Then CSO Michael Hayden said small-molecule CGRP antagonists are “highly complementary” to TEV-48125, or fremanezumab, an anti-CGRP antibody.
But now Hayden is gone, and Teva hit a roadblock last month with fremanezumab when its manufacturer ran into issues with the FDA. A delayed launch would put Teva behind some seriously competitive rivals, including both big pharma (Amgen/Novartis, Eli Lilly) and small biotechs like Alder.
Sosei, meanwhile, seems upbeat about the prospect of the drug now back in its hands. Here’s Sosei’s chief R&D officer and Heptares co-founder, Malcolm Weir:
Thanks to this excellent work by the combined teams under the alliance, and following the return of the assets, we are now well positioned to rapidly progress HTL0022562 into the clinic as part of our wholly-owned pipeline. HTL0022562 has very interesting and differentiated properties compared to other small molecule and antibody antagonists, and we look forward to continuing its development.
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