Release Details

SAN DIEGO, Dec. 2 /PRNewswire/ -- Neurocrine Biosciences (Nasdaq: NBIX) today announced that its partner Janssen Pharmaceutica, N.V. has initiated a Phase I clinical trial on NBI-30775 (R121919), a corticotropin releasing factor (CRF) receptor antagonist for anxiety and depression. NBI-30775 is the Company's first CRF product to enter clinical trials. The Phase I trial is intended to determine safety, the maximally tolerated dose and pharmacokinetics of the compound in healthy volunteers. Neurocrine Biosciences will receive a milestone payment from Janssen for initiation of the development candidate into clinical trials.

CRF functions as a neurotransmitter in the brain and is believed to play a critical role in coordinating psychological and behavioral responses to stress. There are several diseases and disorders such as anxiety and depression in which CRF levels are increased. The deleterious effects of high levels of CRF may be countered by the administration of selective CRF receptor antagonists. Preclinical and clinical evidence suggests that current therapies, such as antidepressants and anxiolytics, produce their therapeutic effects, in part, by modulation of CRF in the brain. Therefore Neurocrine believes that specific and selective CRF receptor antagonists should have more rapid onset and lack of addictive properties than existing therapies.

"This trial represents a significant development milestone toward the therapeutic advancement of our CRF technology. NBI-30775 is an interesting compound, particularly because of its potential for improved efficacy, which if successful in clinical development, may make this development candidate a potential replacement over currently available anxiolytics and antidepressants," said Gary A. Lyons, president and chief executive officer of Neurocrine Biosciences.

Neurocrine Biosciences is a leading neuroimmunology company focused on the discovery and development of novel therapeutics to treat diseases and disorders of the central nervous and immune system such as anxiety, depression, Alzheimer's disease, obesity and multiple sclerosis.

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.

The statements in this press release that relate to the continued profitability of the Company, the continued funding and progress of Neurocrine's programs, the continuation of strategic partnerships, the expected date for the entry into clinical trials of the Company's development candidates, and the potential development of commercial products are forward looking statements. Such forward looking statements involve risks and uncertainties, including, without limitation, that research funding and development will continue under Neurocrine's strategic partnerships in a timely manner consistent with Neurocrine's objectives, that research and development candidates will successfully proceed through pre-clinical and early stage clinical trials, that development candidates will prove effective for treatment in humans in later stage clinical trials, the timely receipt of regulatory clearances required for clinical testing, manufacturing and marketing of products, the potential impact of competitive technologies and potential products, and the other risks and uncertainties outlined in the Company's form 10-K constituting a part thereof for the year ending December 31, 1996. Actual results and the 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
CONTACT: Elizabeth Foster or Paul Hawran, both of Neurocrine Biosciences, 619-658-7600, or http://www.neurocrine.com