Pharma Focus Asia

Sunovion, Sumitomo Dainippon Pharma and Otsuka Enter Worldwide Development and Commercialization Collaboration

Friday, October 01, 2021

Sunovion Pharmaceuticals Inc., its parent company Sumitomo Dainippon Pharma Co., Ltd. (Sumitomo Dainippon Pharma) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced today that the companies have entered into a worldwide license agreement for the joint development and commercialization of four compounds: ulotaront (SEP-363856), non-racemic ratio of amisulpride enantiomers (SEP-4199), SEP-378614 and SEP-380135.

Leveraging their complementary therapeutic area expertise and capabilities, the companies expect to fully explore the medical potential of the compounds in the collaboration, and accelerate development timelines, to bring forward important treatments for people living with neuropsychiatric health conditions worldwide. Otsuka’s subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc., will jointly lead, together with Sunovion, the effort to advance the research and development program worldwide, as well as plan for future commercial activities.

“Sunovion, with our parent company Sumitomo Dainippon Pharma, is proud to collaborate with Otsuka in a shared mission to contribute towards improved lives and better health globally,” said Antony Loebel, M.D., President and Chief Executive Officer of Sunovion. “Otsuka’s recognition of the significant value of these assets reflects the innovative discovery and development efforts at Sunovion over the past decade, as well as our neuropsychiatry commercialization expertise and capabilities. We look forward to working with Otsuka colleagues as we advance novel compounds to treat patients with serious neuropsychiatric conditions.”

“We are pleased to have signed this agreement with Otsuka, which has wide global reach and significant neuropsychiatry expertise. We will work together to more rapidly and reliably develop and commercialize valuable pharmaceuticals for patients around the world with the expectation that these new medications will grow,” said Hiroshi Nomura, President and Chief Executive Officer of Sumitomo Dainippon Pharma. “Sumitomo Dainippon Pharma aims to achieve sustained growth through global collaboration in anticipation of future changes in the business environment. This collaboration is a major step forward in this initiative.”

"Otsuka has been committed to providing new antipsychotics that contribute to patients worldwide in the field of neuropsychiatry by leveraging internal capabilities and external collaborations, starting with the launch of antipsychotics in the U.S. in 2002,” said Makoto Inoue, President and Representative Director of Otsuka. “We are advancing in new areas such as the development of drugs to treat agitation associated with dementia of the Alzheimer’s type and the deployment of the world's first digital medicine. Through this agreement, we are confident the companies will be able to deliver even more value to patients through the experience and networks that we have cultivated over many years worldwide.”

This collaboration recognizes that there is a great need for novel treatments in the area of neuropsychiatric medicine development. The companies are focused on working together on solutions to address these areas of unmet medical need by advancing four promising compounds―ulotaront (SEP-363856), SEP-4199, SEP-378614 and SEP-380135―that address serious neuropsychiatric disorders. The goal of the co-development programs is to contribute to changing the course of serious medical conditions and provide new treatment options to patients and healthcare providers globally.

Upon the completion of the agreement, in addition to an upfront payment of USD 270 million, Sunovion is eligible for development milestone payments of up to USD 620 million for the four compounds and relevant sales milestone payments. Sunovion and Otsuka will share profits from the four compounds, as well as all expenses for clinical studies, applications for approval, and commercialization in each country. Additional details regarding terms of the agreement are not being disclosed.

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