As a result of a recent portfolio prioritization, Israel’s Teva Pharmaceutical Industries (NYSE: TEVA) has decided not to continue to develop and commercialize lead candidate HTL0022562 and other novel small molecule CGRP antagonists for the treatment of migraine and other severe headache, under an agreement with Japan’s Sosei Group (TSE Mothers Index: 4565), thus returning rights to the latter, whose shares gained over 7% to 10,050 yen on the news.
HTL0022562 is a novel, potent, and highly selective small molecule CGRP antagonist designed by Sosei’s wholly-owned subsidiary Heptares Therapeutics using its proprietary structure-based drug design platform. The candidate emerged from a rigorous selection process under the alliance with Teva based on its highly differentiated preclinical data. The first dosing in a Phase I clinical trial in healthy volunteers was expected in late 2018. Sosei will now undertake a detailed review of the programs and update the market later this year on the new expected timing for HTL0022562’s entry into Phase I clinical trials following a formal handover from Teva.
As part of the reversion package, Sosei will also receive the full preclinical data set generated by Teva under the partnership. In regaining the worldwide development and commercialization rights acquired by Teva in 2015 in a $420 million-plus deal, there is no immediate or material financial impact to Sosei, the Japanese firm stated. Going forward, as a wholly-owned pipeline program, Sosei will be responsible for the costs associated with developing HTL0022562 or any other small molecule CGRP antagonists.
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