Release Details

SAN DIEGO, April 8 /PRNewswire/ -- Neurocrine Biosciences (Nasdaq: NBIX) today announced the successful completion of a Phase Ib study of NBI-34060, Neurocrine's GABA(A) receptor subtype agonist designed to induce sleep with an improved side effect profile relative to currently available drugs to treat insomnia. The Phase Ib multiple dose, dose-escalating study, conducted in healthy volunteers, found NBI-34060 to be safe and well-tolerated across a broad dose range. The most frequently reported adverse events were tiredness and drowsiness, strong indicators of the expected pharmacodynamic effects. These results support further investigation of NBI-34060 as a sedative hypnotic agent.

The Phase Ib study was a double-blind, randomized controlled clinical trial. The objectives of the study were to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of multiple increasing doses of NBI-34060 in healthy volunteers. The study was conducted at the Parexel Institute of Clinical Pharmacology in Germany and included 30 healthy volunteers in three treatment arms (NBI-34060 vs. placebo vs. active drug).

"We are currently finalizing the design for a Phase II clinical program and will also be conducting additional pharmacokinetic and pharmacodynamic studies of NBI-34060 to determine the optimal dose and to compare and contrast the effectiveness of additional formulations with that of marketed therapeutic agents. With worldwide sales in excess of $1 billion for existing sedative-hypnotic agents and market share dominated by one or two leading compounds, Neurocrine is actively pursuing comparative trials of NBI-34060 against market leaders," said Stephen G. Marcus, M.D., Senior Vice President Clinical Development and Regulatory Affairs and Chief Medical Officer for Neurocrine Biosciences, Inc.

"Neurocrine's insomnia program will be the fourth program advancing into Phase II clinical trials in 1999. We are continuing to develop a diverse portfolio of therapeutics that address the significant markets in CNS related diseases and represent improvements over currently available therapeutics," said Gary A. Lyons, President and Chief Executive Officer of Neurocrine Biosciences, Inc.

Preclinical studies have generated data suggesting that NBI-34060 may produce a more rapid onset of sleep and fewer next-day hangover effects compared to currently marketed products. Preclinical studies have also suggested that NBI-34060 has minimal interaction with alcohol and may not produce rapid tolerance or amnesia at effective sleep promoting doses.

Neurocrine's compound, NBI-34060, is a sleep-promoting drug that, like the benzodiazepines, produces its effects by enhancing the action of the inhibitory neurotransmitter GABA. To achieve this, NBI-34060 binds to specific sites on the GABA(A) receptor, the same site that is the target of benzodiazepines. Consequently, NBI-34060 works through a proven mechanism, however, NBI-34060 is a non-benzodiazepine in chemical structure, which shows greater selectivity for GABA(A) receptor subtypes, and therefore is expected to have an improved side effect profile. Preclinical studies indicate that NBI-34060 is more potent which is an advantage over existing therapies and has an improved safety profile compared to Ambien(R).

Insomnia is a frequent complaint in Western countries being reported by up to 45% of the adult population, with an even higher prevalence in the elderly. Insomnia is of the most concern because the effects of sleeplessness can influence quality of life and in some cases, compromise the safety of the patient and others, such as in car accidents. Historically, benzodiazepines have been the major class of drugs used to treat insomnia. While the clinical efficacy of current benzodiazepines such as Halcion have been well established, they are associated with side effects including sedation and/or amnesic effects (memory impairment), development of rapid tolerance, potential for abuse and withdrawal symptoms as well as a next day hangover effects.

Neurocrine has now advanced five programs into development. The Company's CRF receptor antagonist is currently in Phase II clinical development with its partner, Janssen Pharmaceutica, for anxiety/depression. Neurocrine and its partner, Novartis Pharmaceuticals, are conducting their second Phase II clinical trial with Neurocrine's APL compound in patients with multiple sclerosis. Neurocrine is also conducting a Phase I/II trial with NBI-3001 for glioblastoma (malignant brain tumors) and a Phase I trial with a second APL compound (NBI-6024) for Type 1 diabetes.

Neurocrine Biosciences is a leading neuroscience company focused on the discovery and development of novel therapeutics for neuropsychiatric, neuroinflammatory and neurodegenerative diseases and disorders. The Company's neuroscience, endocrine and immunology disciplines provide a unique biological understanding of the molecular interaction between central nervous, immune and endocrine systems for the development of therapeutic interventions for anxiety, depression, Alzheimer's disease, Parkinson's disease, stroke, traumatic brain injury, multiple sclerosis, obesity and diabetes.

Neurocrine Biosciences, Inc. news releases are available free of charge though PR Newswire's Company News On-Call fax service. For a menu of Neurocrine's previous releases, or to receive a specific release via fax call: (800) 758-5804, ext. 604138, or use the Internet via http://www.prnewswire.com.

In addition to historical facts, this press release contains 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 research and development programs and business and finances including, but not limited to, risks and uncertainties associated with, or arising out of, drug discovery, pre-clinical and clinical development of products including risk that research may not generate development candidates, development candidates will not successfully proceed through early clinical trials or that in later stage clinical trials will not show that they are effective in treating humans; determinations by regulatory and governmental authorities; changes in relationships with strategic partners and dependence upon strategic partners for performance of clinical and commercialization activities under collaborative agreements including potential for any collaboration agreement to be terminated without any product success; uncertainties relating to patent protection and intellectual property rights of third parties; impact of competitive products and technological changes; availability of capital and cost of capital; and other material risks. A more complete description of these risks can be found in the Company's Form 10K for the year ended December 31, 1998 and the current form 10Q each of which should be read before making any investment in Neurocrine common stock. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.
SOURCE Neurocrine Biosciences
Web site: http: //www.neurocrine.com
Company News On-Call: http: //www.prnewswire.com/comp/604138.html or fax, 800-758-5804, ext. 604138
CONTACT: Elizabeth Foster or Paul Hawran of Neurocrine Biosciences, 619-658-7600; or Media: Justin Jackson of Burns McClellan, 212-213-0006, ext. 27