2021-10-01| Asia-Pacific

Japan’s Otsuka Inks $890M Deal with Sunovion to Target Neurological Illness

by Tyler Chen
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Japan’s Otsuka Pharmaceutical signed an $890 million deal with Sumitomo Dainippon Pharma’s U.S. subsidiary Sunovion Pharmaceuticals on September 30. The two Japanese pharmaceutical giants are on a mission to advance the clinical progress of 4 novel compounds.


Details of the $890M Deal

The 4 compounds are SEP-363856, SEP-4199, SEP-378614, and SEP-380135, which are designed to treat patients with psychiatric and neurological illnesses, specifically schizophrenia or bipolar 1 disorder. All of them are developed by Sunovion and its strategic partners.

As per the terms, Sunovion is expected to receive an upfront payment of $270 million and up to $620 million in developmental milestone payments. Otsuka is also dangling the prospect of bonus payments if the compounds obtain additional indications or reach sales milestones.  

Otsuka will be responsible for bringing the compounds into the markets of 41 countries including certain regions in Europe. Meanwhile, Sunovion will handle commercialization in the United States, Canada, Japan, and Asia (China, Taiwan, Singapore, Thailand, Vietnam, and Malaysia).


The 4 Compounds to Treat Neurological Illness

Here are the 4 compounds mentioned in the deal. First of all, SEP-363856, also known as ulotaront, is a trace amine-associated receptor 1 (TAAR1) agonist with serotonin 5-HT1A agonist activity. It is the first TAAR1 agonist to enter into Phase 3 trials in adults and adolescents (13 to 17 years) with schizophrenia and is also in Phase 2/3 trial in Japan and China. In May 2019, USFDA granted SEP-363856 Breakthrough Therapy Designation for the indication.

Next, SEP-4199 is a small-molecule oral agent with a non-racemic ratio of amisulpride enantiomers. It is currently in Phase 3 trial in the U.S. to examine efficacy and safety on patients with bipolar 1 depression. Meanwhile, Sunovion is preparing to launch SEP-4199’s Phase 3 trial in Japan.

Furthermore, SEP-378614 and SEP-380135 are both in Phase 1 trial in the U.S. Both of them has shown positive responses in preclinical studies. SEP-378614 displayed a long-lasting antidepressant-like activity and enhanced neuroplasticity. SEP-380135 demonstrated efficacy against symptoms in dementia, including aggression, psychomotor hyperactivity, and depression.

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