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PCN-101 (R-ketamine) for depressive disorders

Posted in Industry News on 2nd Apr 2021

Perception Neuroscience and Otsuka Pharmaceutical announce collaboration in Japan

Perception Neuroscience (Perception), an atai Life Sciences (atai) company focused on developing innovative therapies in neuropsychiatric disorders, and Otsuka Pharmaceutical Co., Ltd. (Otsuka), announce a collaboration and licensing agreement for the development and commercialisation of Perception’s lead molecule, PCN-101 (R-ketamine) in Japan as a potential treatment for mood disorders such as major depressive disorder (MDD) and treatment-resistant depression (TRD). Outside of Japan, Perception is developing PCN-101 for the treatment of treatment-resistant depression.

PCN-101 is a formulation of R-ketamine, a single isomer of ketamine that belongs to a new generation of glutamate receptor modulators, being developed as a rapid acting antidepressant (RAAD). In nonclinical depression models it possessed more durable and potent effects than S-ketamine, and potentially a more favorable safety and tolerability profile. A Phase 1, single ascending dose study has been completed for PCN-101 and a Phase 2 proof-of-concept study in TRD is planned to be initiated by Perception in the first half of 2021.

Under the terms of the license, Otsuka will have exclusive rights to develop and commercialise products containing PCN-101 in Japan. Otsuka will undertake development, regulatory, and commercialisation activities in Japan, with input and guidance from both companies. Perception will receive an upfront payment of $20 million, which will help fund the company’s overall development of treatments. In addition, Perception will be eligible to receive development, regulatory and commercial milestones, as well as tiered, double-digit royalties on future sales.

“Otsuka is one of the world’s premier pharmaceutical companies in the neuropsychiatric space.” said Terence Kelly, PhD, CEO of Perception. “To have such a strong collaborator at this early stage of development is a significant vote of confidence in the potential of PCN-101 for patients suffering from depression.”

Florian Brand, CEO and co-founder of atai, said, “Otsuka is dedicated to finding unconventional solutions to treat mental health disorders with a deepening focus on digital medicine. Its innovative approach to mental health paired with their experience in commercializing neuropsychiatric drugs as demonstrated by the successful roll-out of products such as Rexulti and Abilify Maintena, makes Otsuka a great company for us to work with. We look forward to working together with them on Perception’s lead compound”.

Makoto Inoue, president of Otsuka Pharmaceutical, remarked, “We have a long and deep engagement in the CNS  field, including our in-line products Rexulti, Abilify Maintena, and specific to the U.S, the first-in-the-world digital medicine, Abilify Mycite. Looking to the future, Perception Neuroscience’s PCN-101, a candidate with rapid onset for use in treatment-resistant depression, could provide an urgently needed treatment option. Perception Neuroscience is uniquely positioned to work with us in Japan on this urgent task.”