Teva Pharmaceutical Industries has ended a 2.5-year, up-to-$410 million-plus collaboration with Sosei Group’s Heptares Therapeutics subsidiary to develop and commercialize Heptares’ lead candidate HTL0022562 and other novel small-molecule calcitonin gene-related peptide (CGRP) antagonists for migraine and other severe headaches, Sosei said today.

Sosei said Teva’s termination of the companies’ licensing and drug discovery agreement reflected Teva’s restructuring announced in December 2017, which the company has promised will include a “thorough” review of its R&D programs as well as the elimination of 14,000 positions and shutdown of R&D facilities worldwide.

As a result, Sosei said, it has regained rights to HTL0022562, which was discovered by Heptares through its proprietary structure-based drug design platform for targeting GPCRs. The platform uses Stabilized Receptor or “StaR®” technology to create StaR proteins, GPCRs with point mutations designed to improve thermostability without disrupting pharmacology.

HTL002562 emerged as the collaboration’s first candidate based on positive preclinical data, a dataset Teva has agreed to return to Sosei.

HTL0022562 had been expected to begin a Phase I trial in healthy participants late this year. Sosei said today it will undertake a detailed review of the CGRP programs and announce a new timeframe for entering the clinic “later this year.”

“With c.$280 million of cash on balance sheet [as of December 31, 2017], we are well positioned to take this candidate forward and capture greater value for our shareholders,” Sosei CEO Peter Bains said in a statement.


“Very Interesting and Differentiated”

Added Sosei Chief R&D Officer Malcolm Weir, Ph.D., “HTL0022562 has very interesting and differentiated properties compared to other small-molecule and antibody antagonists, and we look forward to continuing its development.”

CGRP is released during migraine attacks and can trigger migraines in patients. As elevated levels of CGRP are found in people with migraine headaches, the companies reasoned that blocking CGRP activity could be a validated mechanism of action for relieving pain, as well as for preventing migraines.

Teva and Heptares launched the collaboration in November 2015, saying at the time that Heptares could generate up to $410 million-plus in return for Teva receiving worldwide development and commercial rights to new CGRP antagonists codeveloped by the companies.

Teva agreed to pay Heptares $10 million upfront, and up to $400 million in payments tied to achieving research, development, and commercialization milestones. Heptares was also eligible to receive royalties on net sales of products resulting from the alliance.

Back then, Michael Hayden, M.D., Ph.D., Teva’s then-president of global R&D and CSO, said that Heptares’ GPCRs were complementary to Teva’s fremanezumab, an anti-CGRP monoclonal antibody being developed for prevention of migraine.

Last year, Teva inked an agreement allowing Otsuka Pharmaceutical to conduct Phase II and III clinical trials for fremanezumab, in return for Otsuka paying Teva $50 million upfront and unspecified additional milestone payments tied to achieving filing and regulatory approval in Japan, and specified revenue targets, plus royalties.

Dr. Hayden departed Teva at the end of 2017.

Sosei said it would not see an immediate or material financial impact from regaining rights to HTL0022562 and other CGRP programs.

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