Pharma BD Deal Intelligence
On September 30, 2021, Sunovion and its parent Sumitomo Dainippon Pharma entered a worldwide development and commercialization collaboration with Otsuka covering four psychiatry/neurology compounds: ulotaront (SEP-363856), a Phase 3 TAAR1/5-HT1A agonist for schizophrenia; SEP-4199 (bipolar I depression); SEP-378614; and SEP-380135. Otsuka paid Sunovion $270M upfront and the partners shared development costs and profits in designated regions, with up to $620M in development milestones plus sales milestones (total disclosed value ~$890M+). In July 2023 the Phase 3 DIAMOND 1 and DIAMOND 2 schizophrenia trials missed their primary endpoints, which the companies attributed to a high placebo response. On March 15, 2024 the parties amended the agreement: Otsuka took exclusive worldwide rights to develop, manufacture and commercialize ulotaront and SEP-380135 (with Otsuka bearing study costs from January 2024 and paying up to ~$30M in milestones plus royalties, no upfront), while SEP-4199 and SEP-378614 were excluded as Sumitomo refocused on oncology and regenerative medicine. Otsuka has since relaunched a Phase 3 schizophrenia study (NCT06894212) and continues ulotaront programs in major depressive disorder and generalized anxiety disorder.