Sosei Heptares and Biohaven Enter Global Collaboration and License Agreement to Advance Novel Small-Molecule CGRP Antagonist Portfolio

TOKYO and CAMBRIDGE, England, Dec. 1, 2020 /PRNewswire/ -- 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.

Enquiries:

Sosei Heptares – Media and Investor Relations
Hironoshin Nomura, SVP Investor Relations and Corporate Strategy
+81 (0)3 6679 2178 | [email protected]

Shinichiro Nishishita, VP Investor Relations, Head of Regulatory Disclosures
+81 (0)3 5210 3399 | [email protected]

Citigate Dewe Rogerson

Yas Fukuda – Japanese Media
+81 (0)3 4360 9234 | [email protected]

Mark Swallow, David Dible – International Media
+44 (0)20 7638 9571 | [email protected]

Sosei Group Forward-looking statements

This press release contains forward-looking statements, including statements about the discovery, development and commercialization of products. Various risks may cause Sosei Group Corporation's actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Biohaven Forward-looking statements

This press release also includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of Biohaven's management about the potential use of Biohaven's CGRP antagonists as a preventative treatment for patients with migraine and treatment of other CGRP-mediated diseases. Factors that could affect these forward-looking statements include those related to: Biohaven's ability to effectively develop a CGRP antagonist as a preventative treatment for patients with migraine and treatment of other CGRP-mediated diseases, complying with applicable U.S. regulatory requirements, the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials, the timing of planned interactions and filings with the FDA, the timing and outcome of expected regulatory filings, the potential commercialization of Biohaven's product candidates, the potential for Biohaven's product candidates to be first in class or best in class therapies and the effectiveness and safety of Biohaven's product candidates. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of Biohaven's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission on February 26, 2020 and Biohaven's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 filed with the Securities and Exchange Commission on November 9, 2020. The forward-looking statements are made as of this date and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

SOURCE Sosei Heptares