Neurocrine Biosciences Gains Exclusive Rights to Osavampator for Depression Treatment Outside Japan
Key Insights
Neurocrine Biosciences amended its agreement with Takeda to obtain exclusive worldwide rights to develop and commercialize osavampator for major depressive disorder (search) (MDD (search)), excluding Japan.
Osavampator (NBI-1065845) demonstrated statistically significant improvements in depression symptoms in a Phase 2 trial, meeting primary and key secondary endpoints.
Neurocrine plans to initiate a Phase 3 program for osavampator in the first half of 2025, following a successful End-of-Phase 2 meeting with the FDA.
Neurocrine Biosciences has expanded its collaboration with Takeda Pharmaceutical (search), securing exclusive global rights (excluding Japan) to develop and commercialize osavampator (NBI-1065845/TAK-653) for major depressive disorder (search) (MDD (search)). This strategic move positions Neurocrine to advance osavampator through Phase 3 trials, with the aim of providing a novel treatment option for patients who do not respond adequately to existing therapies.
The amended agreement grants Neurocrine exclusive rights for all indications of osavampator, a compound being studied for the treatment of MDD (search), in all territories worldwide except Japan, where Takeda will reacquire exclusive rights. Takeda will handle development costs in Japan, while Neurocrine will manage costs in all other regions. Both companies are eligible to receive royalty payments based on sales in their respective territories.
Phase 2 SAVITRI Study Results
In April 2024, Neurocrine announced positive topline data from its Phase 2 SAVITRI study. The trial evaluated the efficacy, safety, and tolerability of once-daily, oral osavampator in adult subjects with MDD (search). The study met its primary endpoint, demonstrating a statistically significant change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 28. A key secondary endpoint was also met, showing a statistically significant change at Day 56. The drug did not trigger serious adverse events.
Strategic Implications for Neurocrine
According to Stifel analysts, this amendment is viewed as an "incremental positive" for Neurocrine, granting them greater control over a potentially high-value asset. While considered a "high-risk/high-reward asset" due to limited disclosure since the Phase 2 readout, osavampator holds promise as a novel treatment for MDD (search). Neurocrine anticipates initiating a Phase 3 registrational study in the first half of 2025 to further evaluate the efficacy, safety, and tolerability of osavampator as an adjunctive treatment to antidepressants for MDD.
Background of the Collaboration
Neurocrine and Takeda initially entered into a strategic collaboration in 2020 to develop and commercialize compounds for depression and schizophrenia. This collaboration included an exclusive license to osavampator and NBI-1070770, as well as a preclinical GPR139 (search) antagonist development program. However, in November 2023, Neurocrine discontinued development of NBI-1065846 after disappointing Phase 2 results in MDD (search).