– Biohaven acquires exclusive global rights to a portfolio of novel, small-molecule CGRP antagonists

– The lead candidate, HTL0022562, has advanced through preclinical development demonstrating promising and differentiated properties for further investigation in human trials

– Sosei Heptares will receive an upfront payment of US$10 million, plus downstream payments of up to US$370 million, plus tiered royalties

TOKYO, Japan and CAMBRIDGE, UK I December 1, 2020 I Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”,NYSE: BHVN).

Under the agreement, Biohaven will receive exclusive global rights to develop, manufacture and commercialize a portfolio of novel, small-molecule CGRP receptor antagonists discovered by Sosei Heptares for the treatment of CGRP-mediated disorders. The portfolio includes the lead candidate HTL0022562, which has advanced through preclinical development demonstrating promising and differentiated properties for further investigation in human trials.

In return, Sosei Heptares will receive an upfront payment of US$10 million in the form of cash consideration and Biohaven common shares, research funding, and is eligible to receive additional development, regulatory and commercialization milestone payments of up to US$370 million. In addition, Sosei Heptares will be eligible to receive tiered royalties on net sales of products resulting from the collaboration.

Vlad Coric, M.D., Chief Executive Officer of Biohaven, said: “We are excited to enter into this agreement with Sosei Heptares, a world leader in GPCR drug discovery. Biohaven launched NURTECä ODT (rimegepant), our lead CGRP receptor antagonist oral small molecule for the acute treatment of migraine in March of this year in the USA, and have submitted an sNDA for the preventive treatment of migraine with an expected PDUFA in the second quarter of 2021. In addition, we have advanced zavegepant, our intra-nasal CGRP receptor antagonist, successfully through its first pivotal trial, also for the acute treatment of migraine. We are now committed to pursuing other CGRP-mediated diseases through advancing novel investigational agents such as HTL0022562 into human studies.”

Shinichi Tamura, Chairman, President and CEO of Sosei Heptares, commented: “We are delighted to enter this collaboration and license agreement with Biohaven for our portfolio of novel CGRP receptor antagonists. HTL0022562 has already advanced successfully through a rigorous preclinical program and we are confident that the CGRP expertise and resources Biohaven brings will enable the further development of this and other promising CGRP antagonist candidates into human clinical trials. This new agreement is an excellent example of our strategy in action, which is focused on achieving sustainable profitability through drug discovery, early development and partnering. It showcases our ability to advance strategically important candidates against specific disease targets through early development to become attractive partnering opportunities in parallel with the multi-target deals we have established. We look forward to working on this new collaboration with Biohaven, a world leader in the clinical development of CGRP-targeted therapies.”

Abbreviations used: CGRP – calcitonin gene-related peptide. GPCR – G protein-coupled receptors

About Sosei Heptares

We are an international biopharmaceutical group focused on the discovery and early development of new medicines originating from our proprietary GPCR-targeted StaR® technology and structure-based drug design platform capabilities. We are advancing a broad and deep pipeline of novel medicines across multiple therapeutic areas, including neurology, immunology, gastroenterology and inflammatory diseases.

We have established partnerships with some of the world’s leading pharmaceutical companies, including AbbVie, AstraZeneca, Genentech (Roche), Novartis, Pfizer and Takeda and additionally with multiple emerging technology companies. Sosei Heptares is headquartered in Tokyo, Japan with corporate and R&D facilities in Cambridge, UK.

“Sosei Heptares” is the corporate brand and trademark of Sosei Group Corporation, which is listed on the Tokyo Stock Exchange (ticker: 4565). Sosei, Heptares, the logo and StaR® are trademarks of Sosei Group companies.

For more information, please visit https://www.soseiheptares.com/

LinkedIn: @soseiheptaresco | Twitter: @soseiheptaresco | YouTube: @soseiheptaresco

About Biohaven

Biohaven (NYSE: BHVN) is a commercial-stage biopharmaceutical company with a portfolio of innovative, best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases, including rare disorders. Biohaven’s neuroinnovation portfolio includes FDA-approved NURTEC™ ODT (rimegepant) for the acute treatment of migraine and a broad pipeline of late-stage product candidates across three distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine; glutamate modulation for obsessive-compulsive disorder, Alzheimer’s disease, and spinocerebellar ataxia; and myeloperoxidase (MPO) inhibition for multiple system atrophy and amyotrophic lateral sclerosis. More information about Biohaven is available at www.biohavenpharma.com

NURTEC is a trademark of Biohaven Pharmaceutical Ireland DAC.

About CGRP

CGRP is an important neuropeptide believed to be involved in multiple neuro-inflammatory and neuro-immune diseases. CGRP receptor antagonism interrupts pathologic signals in CGRP-mediated diseases, such as migraine. Following the success of this approach in migraine, Biohaven is exploring the potential of this approach in other neuro-inflammatory and neuro-immune diseases, including COVID-19.

SOURCE: Sosei Heptares