Takeda Pharmaceutical will rely on Neurocrine Biosciences to develop and commercialize three clinical-stage drug candidates and four preclinical programs in Takeda’s early-to-mid-stage psychiatry pipeline, the companies said today, through a collaboration that could generate more than $2 billion for the pharma giant.

Takeda has granted an exclusive license to Neurocrine Biosciences for the seven pipeline programs, which include potential treatments for schizophrenia, treatment-resistant depression, and anhedonia. All three have reached the clinic and completed Phase I studies:

  • TAK-831, a potential first-in-class D-Amino Acid Oxidase (DAAO) inhibitor that is currently in ongoing Phase II studies—including the Phase II INTERACT proof-of-concept study in negative symptoms of schizophrenia (NCT03382639).
  • TAK-653, a potential first-in-class Alpha-Amino-3-Hydroxy-5-Methyl-4-Isoxazole Propionic Acid (AMPA) potentiator that is a Phase II study-ready compound with the potential to be developed for treatment-resistant depression, according to Takeda.
  • TAK-041, a potential first-in-class G Protein-Coupled Receptor 139 (GPR139) agonist that is a Phase II study-ready compound with the potential to be developed for the treatment of anhedonia in depression.

Takeda has not disclosed details of the four preclinical programs that are also part of the collaboration with Neurocrine Biosciences.

Core therapeutic area

“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,” Sarah Sheikh, MD, head, Neuroscience Therapeutic Area Unit at Takeda, said in a statement.

Sheikh noted that neuroscience is one of Takeda’s three core therapeutic areas of focus, along with gastroenterology and oncology, though the pharma’s pipeline also includes plasma-derived therapies, vaccines, and rare disease treatments.

Neurocrine Biosciences has agreed to pay Takeda $120 million in upfront cash, plus up to $495 million in payments tied to achieving development milestones, and up to $1.4 billion tied to achieving commercial milestones. Takeda could also potentially receive double-digit royalties on net sales of products developed through the collaboration.

On an asset-by-asset basis, Takeda may elect to opt in or out of a 50:50 profit share on each of the clinical programs based on specified development events. For any asset in which Takeda is participating in a 50:50 profit share arrangement, Takeda will not be eligible to receive development or commercial milestones.

“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,” added Neurocrine Biosciences CEO Kevin Gorman, PhD. “This strategic partnership enhances our growing pipeline and strengthens our position as a leading neuroscience-focused biopharmaceutical company.”

Building on Ingrezza®

Marc Goodman, a senior research analyst at SVB Leerink covering neuroscience and ophthalmology, said his firm likes Neurocrine’s aggressive approach to diversifying its pipeline into other CNS areas by leveraging the profit stream it has created through its marketed drug Ingrezza® (valbenazine), a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of adults with tardive dyskinesia.

Ingrezza generated $752.9 million in 2019 net product sales, 84% above the $409.6 million reported in 2018. During the first quarter of this year, Ingrezza racked up $231.1 million, up 69% from $136.4 million in Q1 2019.

Goodman also said Neurocrine Biosciences’ deal with Takeda was favorable, and acknowledged that Takeda’s experience in CNS R&D, development, and commercialization made it a potentially strong partner—but added a caveat: “While it’s great to add more ‘shots on goal’ to the pipeline, Neurocrine has chosen products with not much proof of concept data yet for the respective mechanisms as well as lead indications—treatment-resistant depression (TRD) and schizophrenia negative symptoms—that have significant clinical risk because of the many clinical failures in these areas, so we wouldn’t expect the deal to get much credit at this time,” Goodman cautioned.

He added, however: “We look forward to hearing more clinical updates from the company on these mechanisms and products as these high-risk areas also have potential high reward as well.”

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