Dainippon Sumitomo Pharma Co., Ltd. (DSP) announced that it has signed an exclusive license agreement with Neurocrine Biosciences, Inc. (NBI) for Indiplon. DSP will retain the exclusive right to develop and market Indiplon in Japan.

Under the terms of the agreement, DSP will pay NBI an upfront and milestone payments, as well as royalties on product sales in Japan.

Indiplon is a sedative hypnotic agent, for which NBI has worldwide development and commercialization rights. A registration program for Indiplon has recently been completed in the US for the treatment of insomnia.

An estimated 24 million people in Japan experience insomnia and the number is projected to increase under the current circumstances with social stress. Many of the patients have difficulty with initiation of sleep and a safer and more effective therapeutic agent is desired.

Indiplon is a potent and selective non-benzodiazepine medication targeting the GABA-A receptor. It is expected to be effective in the treatment of insomnia primarily with initiation of sleep, and to have safer profiles in terms of the reduction of adverse events, such as hang-over, amnesia and muscle relaxant, based on its shorter half-life and better receptor selectivity compared with the current short-acting insomnia drugs.

DSP has a large product portfolio in the CNS area, and expects to strengthen the lineups by this license agreement for indiplon. DSP will proceed with clinical development shortly with a view to launching indiplon in Japan as early as possible. DSP dedicates itself to contribute the treatment of insomnia and the improvement of the patients' QOL (Quality of Life).

Debiopharm Group is a global biopharmaceutical development specialist that in-licenses promising biologics and small molecule drug candidates, develops its products for global registration and maximum commercial potential for out-licensing to pharmaceutical partners for sales and marketing

Neurocrine Biosciences, Inc is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders.