On September 30, 2021 Sunovion Pharmaceuticals Inc. (Sunovion),its parent company Sumitomo Dainippon Pharma Co., Ltd. (Sumitomo Dainippon Pharma) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) reported 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 (Press release, Sunovion, SEP 30, 2021, View Source [SID1234590587]).
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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.
About Sunovion Compounds
The four clinical-stage assets―ulotaront (SEP-363856), non-racemic ratio of amisulpride enantiomers (SEP-4199), SEP-378614 and SEP-380135―included within the collaboration span early- to late-stage development. The compounds represent a scientifically unique approach to treating symptoms that are not adequately addressed by current therapeutic options and/or for which existing treatments have an unsatisfactory safety and tolerability profile.
Ulotaront (SEP-363856), in Phase 3, is a trace amine-associated receptor 1 (TAAR1) agonist with 5-HT1A agonist activity that is under investigation for the treatment of schizophrenia with additional indications under consideration. Ulotaront was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia. Ulotaront is the first TAAR1 agonist to enter into Phase 3 clinical studies in adults and adolescents (13 to 17 years) with schizophrenia.
Non-racemic amisulpride (SEP-4199) is in Phase 3 clinical development for the treatment of major depressive episodes associated with bipolar I disorder (bipolar depression). Sunovion discovered that the pharmacology of amisulpride is enantiomer-specific and increasing the ratio of R-amisulpride to S-amisulpride increases the potency for serotonin 5-HT7 receptors relative to dopamine D2 receptors. SEP-4199 was designed with an 85:15 ratio of R-amisulpride to S-amisulpride to increase levels of serotonin 5-HT7 activity intended to enhance antidepressant efficacy and produce reduced levels of D2 receptor occupancy appropriate for the treatment of bipolar depression. In September 2021 Sunovion initiated a global clinical Phase 3 study, which is a randomized, double-blind, placebo-controlled, parallel-group, fixed-dosed study for the treatment of bipolar I depression in the U.S. Japan will join this global clinical Phase 3 study.
SEP-378614 and SEP-380135 are in Phase 1 development and can be viewed on the Sunovion pipeline here.
Sunovion discovered ulotaront, SEP-378614, and SEP-380135 in collaboration with PsychoGenics based in part on a mechanism-independent approach using the in vivo phenotypic SmartCube platform and associated artificial intelligence algorithms.
Sunovion has a robust portfolio of clinical and pre-clinical compounds, not included in this agreement, which the company continues to advance for some of the most prevalent, challenging, and underserved neuropsychiatric conditions.
About Neuropsychiatric Disorders
Neuropsychiatric disorders are among the most complex and difficult to treat. Disorders of the brain are often associated with significant and disabling effects on patients, impacting their loved ones and society more broadly. Nearly one in six people worldwide live with a neurological disorder,1 29 million people worldwide are living with bipolar disorder,2 and 20 million people worldwide are living with schizophrenia.3