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Positive Efficacy, Safety Results Announced for Indiplon

SAN DIEGO, Sept. 9 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX - News) today announced positive efficacy and safety results from the Company's Phase III clinical trial with indiplon modified release 15 mg in 229 elderly patients with chronic insomnia. Neurocrine is on track to submit its two New Drug Applications (NDAs) for the immediate and modified release formulations of indiplon beginning in October 2004. The two NDAs will include data from Phase I, II and III clinical trials in over 7400 patients and subjects with over 300,000 patient exposures in one of the most comprehensive clinical programs in insomnia. To date the indiplon clinical program has demonstrated indiplon to be a safe and efficacious treatment option to address the multiple sleep needs of younger and older adult patients such as: falling asleep faster, reducing the number and duration of awakenings, and improving sleep quality. Clinical trials have also demonstrated that indiplon can help patients improve their sleep over a sustained period of time.

Efficacy and Safety Results with Indiplon-MR in Elderly Patients
Efficacy results with the 15 mg dose of indiplon modified release tablets demonstrated a highly statistically significant improvement on the primary endpoint of patient reported Total Sleep Time (sTST) as compared to placebo (p Safety results were similar to what has previously been observed in other indiplon modified release and immediate release studies. Patient reported Global Impression (PGI), a 5 item scale assessing the overall effect of the study drug on sleep, time to fall asleep, amount and quality of the sleep, and the strength of the medication also showed a highly statistically significant improvement over placebo (p Study Design
The study was a randomized, double-blind, placebo-controlled, parallel- group, multi-center, out-patient Phase III clinical trial conducted in 229 elderly patients with sleep maintenance difficulties. The study was conducted at 44 sleep centers in the U.S. Patients received nightly administration of 15 mg of indiplon modified release tablets or placebo over a two-week period.

"We are very pleased with this study, we couldn't have hoped for a better result in all safety and efficacy parameters. As expected, the 15 mg dose showed significant improvement in sleep maintenance at every primary and secondary endpoint, as well as in next day functioning and alertness. Based on these results Neurocrine expects to submit an NDA for indiplon modified release that will include the 15 mg dose. We believe the registration of indiplon modified release and immediate release will provide a broad spectrum of treatment for all sleep disorders including sleep initiation, sleep maintenance, middle of the night awakening and long term chronic usage," said Dr. Henry Pan, Executive Vice President and Chief Medical Officer for Neurocrine Biosciences.

About Indiplon
Indiplon is a unique non-benzodiazapine agent that acts on a specific site of the GABA-A receptor. Indiplon has been shown to bind selectively to the specific subtype of GABA-A receptors within the brain believed to be responsible for promoting sleep. Two formulations of indiplon, immediate release capsules and modified release tablets, are being evaluated in clinical trials to address different types of sleep problems. Indiplon was licensed from DOV Pharmaceutical in 1998.

Insomnia is a prevalent condition in the United States, with approximately 40 percent of the adult population reporting trouble sleeping a few nights per week or more, according to the National Sleep Foundation's (NSF) Sleep in America Poll 2002. Approximately 35 percent of the adult population reports that they have experienced insomnia every night or almost every night within the past year. Insomnia remains a disorder with high unmet medical needs, including prolonged awakenings during the night with difficulty falling back to sleep.

Source: Neurocrine Biosciences, Inc.

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