Sosei Heptares to Regain Worldwide Rights to Muscarinic Agonist Programs

Sosei Heptares to Regain Worldwide Rights to Muscarinic Agonist Programs

Tokyo, Japan and Cambridge, UK, 5 January 2021 – Sosei Group Corporation (“the Company”; TSE: 4565) announces it is to regain the worldwide rights to its muscarinic agonist programs. The program was licensed to Allergan in April 2016, and Allergan was acquired by AbbVie in May 2020.

This decision to return worldwide rights was based on business decisions regarding AbbVie’s pipeline strategy and not on any efficacy, safety or other data related to the collaboration programs.

As a result of this process, AbbVie has notified Sosei Heptares that it will be returning to Sosei Heptares all assets in development under the program, together with all associated intellectual property licensed by Sosei Heptares to Allergan, and all clinical and preclinical data generated under the partnership.

Sosei Heptares will now conduct a full internal review to determine a strategy for the further development and re-partnering of the program. The outcome of this review is expected to be reported around the time of the Company’s full year results presentation in February 2021. The event reported today has no immediate impact on the consolidated financial results for the accounting period ending December 2021. Should any impacts or other matters that require an announcement be identified, the Company will announce such matters promptly.

Shinichi Tamura, Chairman, President and CEO of Sosei Heptares, commented: “We are delighted to regain rights to this portfolio of novel subtype-selective muscarinic receptor agonists (M₄, M₁ and dual M₁/M₄ agonists), including several clinical and preclinical candidates with substantial data associated. We enjoyed a productive relationship with Allergan over the course of our muscarinic agonist collaboration and continue to work positively with AbbVie on a new program in inflammatory diseases that we announced in June last year.

“The considerable progress that we made together with Allergan has reinforced our view in the potential of this approach to create important new products that treat severe and debilitating symptoms of Alzheimer’s disease, schizophrenia and other neurological diseases. We are also encouraged by the growing industry interest and validation of this novel approach to treating these diseases.

“In addition, the R&D collaboration has generated a diverse pipeline of next-generation, selective muscarinic agonists with novel chemistry that have benefitted from insights gained in clinical trials and from advanced drug design technologies. These new and differentiated candidates exhibit highly attractive properties for further development.

“The value of the selective M₁ agonists was enhanced with a signal observed in early clinical trials of HTL0018318, and in addition we have been advancing the development of such agonists with novel chemistry. We will decide which selective M₁ agonist program to prioritise after further study.

“We are excited by this opportunity and look forward to disclosing our strategy for the further development and re-partnering of this program at around the time of our full year results in February 2021.”

About the License Agreement

Sosei Heptares and Allergan entered a global R&D and commercialization partnership in April 2016 under which Allergan licensed exclusive global rights to a broad portfolio of novel subtype-selective muscarinic receptor agonists (M₄, M₁ and dual M₁/M₄ agonists) in development for the treatment of major neurological disorders, including Alzheimer’s disease.

Effective 4 January 2021, the License Agreement is terminated. All intellectual property rights pertaining to the muscarinic program licensed to Allergan and subsequently added to through the collaboration, and all preclinical and clinical data, will be regained by Sosei Heptares.

About Muscarinic Receptors

Muscarinic receptors are G protein-coupled receptors (GPCRs) found in multiple tissues including the brain, cardiovascular system and gastrointestinal tract. Selective activation of M₄ and M₁ receptors in the brain is a clinically validated approach to treating cognitive and neuropsychological symptoms of neurological diseases, including Schizophrenia, Alzheimer’s disease, Parkinson’s disease and others. Until now, attempts to develop medicines that selectively target M₄ and M₁ receptors have been unsuccessful because of side effects caused by the activation of M₂ and M₃ receptors. Highly selective M₄ or M₁ agonists that do not activate M₂ or M₃ therefore are highly sought after and expected to have the potential to address major unmet medical needs with blockbuster potential.