San Diego Business Journal

San Diego-based Neurocrine Biosciences (Nasdaq: NBIX) has entered into a strategic collaboration and licensing agreement with Japan’s Sosei Group to develop potential new treatments for schizophrenia, dementia and other neuropsychiatric disorders. 

Under the terms of the agreement, which was announced Monday, Neurocrine gains development and commercialization rights to a broad portfolio of so-called “receptor agonists” discovered by Sosei Heptares.  

The most advanced program, HTL-0016878, is a selective M4 agonist for which Neurocrine plans to submit an Investigational New Drug application and initiate a placebo-controlled Phase 2 study in 2022 with HTL-0016878 as a potential treatment for schizophrenia. 

The deal calls for Sosei Heptares to retain the rights to develop M1 agonists in Japan, with Neurocrine receiving co-development and profit share options. 

Muscarinic receptors are central to brain function and have been validated as drug targets in psychosis and cognitive disorders.  

Neurocrine said Sosei Heptares has discovered selective muscarinic M4, M1 and M1/M4 dual agonists that offer the potential to deliver therapeutic effects while avoiding both the harmful side effects caused by non-selective agonists and efficacy issues experienced in some older patients.  

"Our partnership collaboration with Sosei Heptares to advance their selective muscarinic agonist portfolio leverages the strengths of both our organizations with one goal in mind, to bring important medicines to patients who need better treatment options," said Dr. Kevin Gorman, CEO at Neurocrine. "We continue to add potential best-in-class compounds to our growing pipeline, which further positions Neurocrine Biosciences as a leading neuroscience-focused biopharmaceutical company." 

Shinichi Tamura, president and CEO of Sosei Heptares, said his company was “delighted” to be able partner with Neurocrine.  

“The deal highlights the significant potential value within this portfolio and brings to bear the substantial expertise of the Neurocrine team, which is highly experienced in developing and commercializing novel products for patients with neurological and psychiatric diseases globally,” Tamura said. “It also enables Sosei Heptares to retain rights in Japan, where we are confident that we can make important progress leveraging our own expertise to advance novel candidates that aim to address this major unmet need.” 

Under the terms of the agreement, Neurocrine will be responsible for development costs associated with the programs globally, except for M1 agonists being developed in Japan.  

Sosei Heptares will receive $100 million upfront licensing payment and is eligible to receive as much as $1.5 billion if the program is successful and gains regulatory approval.