Release Details

- New National Survey Shows Nearly Half of Elderly Have Trouble Sleeping -

SAN DIEGO, June 22 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that data presented this week at the Associated Professional Sleep Societies' (APSS) Annual Meeting showed that indiplon safely and effectively helps elderly patients with chronic insomnia fall asleep faster and stay asleep throughout the night. These results come on the heels of a new survey(1) which reveals the prevalence and impact of insomnia in the elderly.

"Insomnia is prevalent in the elderly and in severe cases can deprive these patients of common enjoyments such as socializing with family and friends or participating in activities they typically enjoy," said Dr. James Walsh, Executive Director, Sleep Medicine and Research Center St. Luke's Hospital, St. Louis, Missouri. "However, elderly patients with insomnia often go undiagnosed and untreated because people believe that insomnia is a normal part of aging, a common misconception. These studies are good news because they show that indiplon can safely provide a good night's sleep for elderly patients with insomnia."

Insomnia -- A Common Problem in the Elderly

According to the survey of U.S. adults ages 65 and older(1), 43% of those polled currently experience at least one or more symptoms of insomnia, including awakening too early (27%), not waking feeling refreshed (25%), difficulty staying asleep (22%), and difficulty falling asleep (17%). Of those who experience sleep difficulties, 60% experience symptoms once a week or more.

Additionally, 45% of those who experience sleep difficulties, say these difficulties have negatively affected their overall quality of life in ways such as being too tired to perform or enjoy daily activities (22%), being unable to stay focused or concentrate on daily activities (19%), and being unable to socialize with others (10%). Almost three-quarters (74%) of those who experience sleep difficulties say they have more trouble sleeping now than they did when they were younger.

New Studies Show Indiplon Effectively Treats Insomnia in Elderly Patients

Results were presented today from two studies evaluating the safety and efficacy of indiplon in treating patients ages 65-85 years with chronic insomnia.

Data Demonstrates Indiplon Capsules Safe and Effective in Elderly with Insomnia

The first study was a randomized, double blind, placebo-controlled Phase III trial evaluating the safety and efficacy of indiplon capsules in 358 elderly patients ages 65-80 with primary insomnia. Patients were randomized to two weeks of treatment with indiplon capsules 5 mg, 10 mg, or placebo.

The primary endpoint for the clinical study was self-reported Latency to Sleep Onset (LSO) or the time it takes patients to fall asleep. Data showed that indiplon capsules resulted in significant improvements in LSO (p0.02 to p0.0001) as compared to placebo. When compared to baseline values, treatment with indiplon resulted in a greater than 50% reduction in LSO. The study also assessed sleep maintenance endpoints including subjective Total Sleep Time (sTST). Results showed that sTST was significantly increased for both doses of indiplon capsules at weeks one and two (p0.007 to p0.0001). Overall, indiplon capsules were well tolerated in the elderly and there were statistically significant improvements in patient-reported sleep parameters associated with sleep quality.

Data Demonstrates Indiplon Tablets Effective in Elderly with Sleep Maintenance Difficulties

The second study was a double blind, placebo-controlled trial evaluating the safety and efficacy of indiplon tablets 15 mg in 229 chronic insomnia patients (ages 65-85 years) with sleep maintenance difficulties.

The primary endpoint for the study was sTST, which is used to measure sleep maintenance. Results showed that treatment with indiplon tablets resulted in significant improvement in sTST at both weeks 1 and 2 (p0.0001) as compared to placebo. Mean improvement in sTST was approximately 50 min for the 15 mg indiplon group compared with just 16 min for placebo. The study also found that indiplon tablets significantly improved LSO at both weeks 1 and 2 (p0.0001). Indiplon also reduced wake after sleep onset (sWASO) by more than 40 minutes from baseline. Indiplon tablets were well tolerated in the elderly and there were statistically significant improvements in patient- reported measures indicating that indiplon tablets helped overall with the time it took them to fall asleep, stay sleep throughout the night, and improve sleep quality.

"Results from these two studies demonstrate the safety of indiplon in treating insomnia in the elderly, a sensitive population that is often one of the most difficult to treat and further underscores the product's established safety profile," said Dr. Henry Pan, Executive Vice President and Chief Medical Officer of Neurocrine Biosciences, Inc. "These data, combined with previously presented data in adults, demonstrate the flexibility of indiplon in effectively treating different types of patients as well as their different insomnia symptoms."

About Indiplon

Indiplon is a unique non-narcotic, non-benzodiazepine 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. Indiplon was developed to address different types of sleep problems. Upon approval, indiplon will be copromoted in the US with Pfizer.

Insomnia is a prevalent condition in the United States. According to the National Sleep Foundation's (NSF) Sleep in America Poll 2005 approximately half of America's adults report that they experienced at least one symptom of insomnia a few nights a week or more in the past year. Sleep loss has been found to impair the ability to perform tasks involving memory, learning, and logical reasoning, yet few people understand the importance of sufficient sleep.

(1) About the Survey

Harris Interactive(R) conducted the telephone survey for Neurocrine Biosciences over two waves between May 12 and 16, 2005 among a nationwide cross section of 456 U.S. adults ages 65 and older, of whom 196 reported that they currently experience sleep difficulties. Figures for age, sex, race, and region were weighted where necessary to align them with their actual proportions in the population. In theory, with a probability sample of this size, one can say with 95 percent certainty that the results for the overall sample of adults 65 and older have a sampling error of plus or minus 5 percentage points. Sampling error for the sub-sample of adults 65 and older who currently experience sleep difficulties is plus or minus 7 percentage points.

Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders. Our product candidates address some of the largest pharmaceutical markets in the world including insomnia, anxiety, depression, diabetes, multiple sclerosis, irritable bowel syndrome, eating disorders, pain, and autoimmunity. Neurocrine Biosciences, Inc. news releases are available through the Company's website via the Internet at http://www.neurocrine.com .

In addition to historical facts, this press release may contain forward- looking statements that involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with Neurocrine's business and finances in general including, but not limited to, risk and uncertainties associated with the Company's indiplon program and planned regulatory activities including, but not limited to; risk that regulatory authorities find our regulatory submissions incomplete or insufficient or otherwise unapprovable; and the other risks described in the Company's report on Form 10-K for the year ended December 31, 2004 and report on Form 10-Q for the quarter ended March 31, 2005. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.

Investor Contacts:
Elizabeth Foster or Claudia Jones of Neurocrine Biosciences
(858) 617-7600

Media Contact:
Lisa Talbot of Cohn & Wolfe
Office: (212) 798-9836
Mobile: (347) 210-8708 on-site

SOURCE Neurocrine Biosciences, Inc.
06/22/2005
CONTACT: Investors, Elizabeth Foster, or Claudia Jones, both of Neurocrine Biosciences, +1-858-617-7600;
or Media, Lisa Talbot of Cohn & Wolfe, Office, +1-212-798-9836, or Mobile, +1-347-210-8708,
for Neurocrine Biosciences, Inc.
Web site: http://www.neurocrine.com
(NBIX)