Perception and Otsuka enter collaboration and licensing deal for depression drug candidate

pharmafile | March 16, 2021 | News story | Manufacturing and Production CNS, Otsuka Pharmaceutical, Perception Neuroscience, depression 

Perception Neuroscience and Otsuka Pharmaceutical have announced a collaboration and licensing agreement for the development and commercialisation of Perception’s lead molecule, PCN-101, in Japan as a potential treatment for mood disorders such as major depressive disorder and treatment-resistant depression (TRD).

Outside of Japan, New York-based 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 favourable safety and tolerability profile.

A Phase I, single ascending dose study has been completed for PCN-101, and a Phase II, proof-of-concept study in TRD is set to be initiated by Perception in the first half of this year.

Under the terms of the deal, Otsuka will have exclusive rights to develop and commercialise products containing PCN-101 in Japan. The company will undertake development, regulatory, and commercialisation activities in Japan, with input and guidance from both parties.

Perception will receive an upfront payment of $20 million, which will contribute to 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.

Terence Kelly, CEO of Perception, said: “Otsuka is one of the world’s premier pharmaceutical companies in the neuropsychiatric space.

“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.”

Makoto Inoue, President of Otsuka Pharmaceutical, also commented: “We have a long and deep engagement in the CNS field, including our in-line products Rexulti, Abilify Maintena, and specific to the US, 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.”

Darcy Jimenez

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