Release Details

SAN DIEGO, July 9 /PRNewswire/ -- Neurocrine Biosciences (Nasdaq: NBIX) announced today that it has signed an exclusive worldwide licensing agreement with DOV Pharmaceuticals, Inc. for a compound in clinical development for the treatment of insomnia. The compound, NBI-34060, works through the activation of the benzodiazepine site on GABA receptors. It is through this mechanism that the currently marketed benzodiazepines produce their sleep-promoting effects. However, NBI-34060, a next generation compound, is chemically distinct from the benzodiazepines with an improved pharmacokinetic profile and receptor subtype selectivity, giving it the potential to reduce the side effects characteristic of the currently marketed benzodiazepines. A Phase I clinical trial evaluating NBI-34060 in normal patients indicated that therapeutic doses appear to be safe and well tolerated with the most commonly noted effect being drowsiness. Neurocrine plans to further evaluate NBI-34060 in a Phase Ib trial this year and to initiate comprehensive Phase II clinical trials in 1999.

While the clinical efficacy of benzodiazepines has been established, significant troublesome side effects are associated with this class of compounds, including interaction with alcohol, development of rapid tolerance, potential for abuse and withdrawal symptoms, next-day hangover effects, and impairment of psychomotor performance and memory. Like the benzodiazepines, NBI-34060 works through potentiation of the effects of the inhibitory neurotransmitter GABA. However, it binds differentially to the GABA Type I site, suggesting a more selective action. Preclinical and clinical studies have generated data suggesting that NBI-34060 may produce a more rapid onset of sleep and lack of next-day hangover effects compared to zolpidem (Ambien(R)) and other currently marketed products. Similarly, studies have also demonstrated that NBI-34060 has minimal interaction with alcohol and does not produce rapid tolerance or amnesia at effective sleep promoting doses.

Under the terms of the licensing and development agreement, Neurocrine will become the exclusive licensee of NBI-34060 for insomnia and all therapeutic indications and will be responsible for worldwide development and commercialization of this compound. Neurocrine has made an equity investment in DOV Pharmaceutical and will pay milestones based upon attainment of certain clinical development and regulatory accomplishments. DOV Pharmaceutical will also receive royalties on the worldwide sales by Neurocrine of approved products resulting from the collaboration.

"We are encouraged by the development potential of this next generation compound for insomnia which works through a proven mechanism. NBI-34060 is an excellent fit with our therapeutic pipeline. We will now have five compounds in clinical development for CNS-related diseases and disorders," said Gary A. Lyons, CEO and president of Neurocrine Biosciences, Inc.

"Considerable preclinical development and an initial Phase I study have provided supportive evidence that NBI-34060 is a potent and rapid sleep- promoter with improved pharmacokinetics over the current generations of benzodiazepines. This indication has clear and well-defined clinical endpoints, which will allow us to aggressively pursue the therapeutic potential of this product," added Stephen G. Marcus M.D., senior vice president, clinical and regulatory affairs and chief medical officer for Neurocrine Biosciences.

DOV Pharmaceutical, Inc. is a drug development company whose primary strategic goal is to license and further develop drugs that already have been advanced to the clinical testing stage. DOV is currently developing several novel pharmacotherapeutics in the areas of central nervous system and cardiovascular diseases, where it has also developed a drug candidate using its own in-house expertise.

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.

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The statements in this press release that relate to the development of NBI-34060 as a potential product by the Company, the expected dates of initiation of such compound into clinical trials, and the potential efficacy of such compound and potential reduction in side effects associated with such compound are forward looking statements. Such forward looking statements involve risks and uncertainties, including without limitation, that compounds which demonstrate efficacy or limited side effects in pre-clinical studies may not prove to be effective for treatment in humans, that development, candidates which have progressed through pre-clinical and early stage clinical trials will not successfully proceed through later stage clinical trials, that the regulatory clearances required for clinical testing, manufacturing and marketing of products may not be received in a timely manner, and the potential adverse impact of competitive technologies and potential products. For discussion of other risks and uncertainties potentially impacting the Company's business, see the Company's form 10-K for the year ending December 31, 1997. Actual results and timing of certain events could differ materially from those indicated in the forward looking statements as a result of these and other factors.
SOURCE Neurocrine Biosciences, Inc.
CONTACT: Elizabeth Foster or Paul Hawran, both of Neurocrine Biosciences, Inc., 619-658-7600; or Burns McClellan or Justin Jackson, 212-213-0006, ext. 27, both for Neurocrine Biosciences, Inc.