Neurocrine and Takeda Ink $2 Billion-Plus Neuroscience Development Deal

San Diego-based Neurocrine Biosciences is partnering with Japan’s Takeda Pharmaceutical to develop and commercialize molecules in Takeda’s early-to-mid-stage psychiatry pipeline. Takeda granted an exclusive license to Neurocrine for seven pipeline programs, including three clinical stage compounds for schizophrenia, treatment-resistant depression and anhedonia (inability to feel pleasure).

Under the terms of the deal, Neurocrine will handle developing and commercializing all pipeline compounds in the collaboration. It will pay Takeda $120 million in cash up front. Takeda will be eligible for development milestones up to $495 million and commercial milestones up to $1.4 billion, as well as double-digit royalties on net sales.

At various points during the development stage, Takeda can choose to opt in or out of a 50/50 profit share on all clinical programs on an asset-by-asset basis. For anything that Takeda is planning to take in the 50/50 deal, it will not be eligible for development or commercial milestones.

“We are excited to collaborate with Takeda to bring life-changing therapies to people living with serious, challenging and under-addressed psychiatric disorders who are in need of better treatment options,” said Kevin Gorman, chief executive officer of Neurocrine. “With our deep understanding in the fields of psychiatry and neurology, we look forward to developing new treatments for schizophrenia, treatment-resistant depression and anhedonia as part of our diverse clinical development pipeline. This strategic partnership enhances our growing pipeline and strengthens our position as a leading neuroscience-focused biopharmaceutical company.

Most recently, on June 7, Neurocrine announced positive data from its completed Phase II trial of crinecerfont in adults with classic congenital adrenal hyperplasia (CAH). CAH is a genetic disorder of the adrenal glands. The drug produced meaningful decreases in elevated adrenocorticotropic hormone (ACTH) and 17-hydroxyprogesterone (17-OHP) levels by 54% to 75% at all doses studied.

The company’s two commercial products are Ingrezza (valbenazine) for tardive dyskinesia and Ongentys (opicapone) for Parkinson’s disease. Its pipeline includes drugs for endometriosis, uterine fibrosis, Huntington disease, polycystic ovary syndrome, epilepsy and unspecified neurology and psychiatric disorders.

In April, Takeda announced a global licensing deal with Rhode Island-based ProThera Biologics to develop a novel plasma-derived Inter-alpha Inhibitor Proteins (IAIP) therapy for acute inflammatory conditions. The two companies will work together on Investigational New Drug (IND)-enabling activities, with development led by Takeda’s Plasma Derived Therapies R&D organization. Takeda will take on responsibility for funding all development and commercialization activities. No financial details were disclosed.

Sarah Sheikh, head of Neuroscience Therapeutic Area Unit at Takeda, said of the new partnership with Neurocrine, “With longstanding experience developing and commercializing therapies for serious neurological and psychiatric disorders, Neurocrine Biosciences is the ideal partner to continue to develop our early-to-mid-stage psychiatry portfolio and bring these potential new therapies to patients. Takeda is deeply committed to Neuroscience as one of our core therapeutic areas. The strategic partnership with Neurocrine Biosciences allows us to continue to build on our leadership in psychiatry and deliver future medicines for these patients while advancing our clinical assets for rare neurological diseases, such as narcolepsy, developmental and epileptic encephalopathies and neurodegenerative conditions.”

The programs includes TAK-831, which has completed multiple Phase I trials and is in ongoing Phase II studies, including the Phase II INTERACT study in schizophrenia; TAK-653, which is Phase II ready for treatment-resistant depression; TAK-041 which is Phase II-ready for anhedonia in depression; and four preclinical programs.