- Japanese drugmakers Sumitomo Dainippon and Otsuka said they will work together to develop four experimental therapies for psychiatric conditions, potentially speeding the medicines' progress through clinical testing.
- The drugs are already under development at Sumitomo's subsidiary Sunovion Pharmaceuticals, a biopharma based in Marlborough, Massachusetts. Two are in Phase 3 testing for schizophrenia and bipolar depression; the other two are in Phase 1 development, and the indications for them are still to be determined.
- Under the deal announced Thursday, Sunovion will receive $270 million up front, plus potential payments of $620 million or more if certain development milestones are reached. Otsuka may also make payments based on sales if the drugs succeed in winning approval.
The agreement has the potential to bolster the neurology businesses at both companies. Otsuka currently sells the long-acting antipsychotic Abilify Maintena, which brought in revenue of about $1 billion last year, and Rexulti, sales of which topped $900 million in 2020.
Sumitomo, meanwhile, is facing the loss of U.S. exclusivity for Latuda, a bipolar depression medicine that has copycats waiting in the wings. In 2018, Sumitomo settled a consolidated patent lawsuit that kept a number of generic competitors out of the U.S. market until February 2023.
The new deal with Otsuka allows for joint development and commercialization of the four compounds, with Sumitomo recording sales in major markets including the U.S. and Japan, and Otsuka recording sales in a number of other countries, including in Europe. Sunovion and Otsuka will share development and regulatory costs and profits.
At the top of the companies' list is ulotaront, also known as SEP-363856, developed along with PsychoGenics. It's already in Phase 3 testing for schizophrenia in the U.S. and Phase 2/3 studies in Japan and China and has the potential for other uses, according to the companies. SEP-4199, meanwhile, this month entered a U.S. Phase 3 study for treatment of bipolar 1 depression that will expand to Japan.
The final two drugs are in Phase 1 testing and also came out of Sunovion's collaboration with PsychoGenics. The companies said SEP-378614 has shown promise in treating depression, while SEP-380135 may help ameliorate behavioral and psychological symptoms of dementia.