Neurocrine Biosciences, a San Diego, California-based pharmaceutical company developing small molecules for neurological and endocrine-related disorders, and Sosei Heptares, a Tokyo-headquartered pharmaceutical company, have entered into a collaboration and licensing agreement to develop muscarinic receptor agonists for schizophrenia, dementia and other neuropsychiatric disorders, in a deal worth up to $2.7 billion ($100 million upfront and $2.6 billion in milestones).

Under the agreement, Neurocrine Biosciences gains development and commercialization rights to a portfolio of clinical and preclinical subtype-selective muscarinic M4, M1 and dual M1/M4 receptor agonists discovered by Sosei Heptares in development for neurological disorders. The most advanced program, HTL-0016878, is a selective M4 agonist. Neurocrine Biosciences plans to submit an investigational new drug application and initiate a Phase II study of HTL-0016878 in 2022 as a potential treatment for schizophrenia.

Under the agreement, Neurocrine Biosciences will be responsible for development costs associated with the programs globally, except for M1 agonists being developed in Japan. Sosei Heptares retains the rights to develop M1 agonists in Japan in all indications, with Neurocrine Biosciences receiving co-development and profit share options.

The R&D collaboration will be conducted jointly by Neurocrine Biosciences and Sosei Heptares to advance preclinical candidates through Phase I clinical studies. The R&D collaboration will be funded by Neurocrine Biosciences.

Sosei Heptares will receive a total of $100 million in upfront cash. Sosei Heptares is eligible to receive up to approximately $1.5 billion related to the successful progression of licensed candidates through to regulatory approval and up to $1.1 billion upon achieving certain global sales milestones of any products developed under the partnership. Sosei Heptares is also eligible to receive tiered royalties ranging from high single digit to mid-teen percentage on future net sales of any products developed under the partnership.

Source: Neurocrine Biosciences and Sosei Heptares