Release Details

SAN DIEGO, Sept. 30 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that encouraging early results of clinical trials with a corticotropin releasing factor (CRF) receptor antagonist, has led to an expansion of its collaboration with Janssen, a subsidiary of Johnson & Johnson. Neurocrine and Janssen have initiated a new phase of research to further develop this class of compounds.

Neurocrine entered into a collaboration with Janssen in February 1995 to focus on the research and development of small molecule CRF receptor antagonists, which has resulted in a compound (R121919) currently in Phase II clinical development for anxiety and depression by Janssen. The Phase I safety clinical trials with R121919 have been completed. An open label Phase II safety and dose-escalating clinical trial with R121919 in patients with major depression is ongoing and the trial is expected to be completed on schedule. Janssen is currently planning several large-scale multi-national, multi-center Phase II clinical trials to begin in mid 2000.

This new phase of the collaboration between Janssen and Neurocrine expands the research and development efforts to identify additional CRF antagonists for the treatment of psychiatric disorders. The expanded agreement allows the collaboration to continue for two additional years and will provide additional funding for a team of Neurocrine scientists to develop new compounds. In addition to the research funding, Neurocrine will receive an initial payment, milestone payments and royalties on worldwide product sales.

"This expanded relationship attests to the progress that has been made in the collaborative development of CRF antagonists for anxiety and depression. The current worldwide market for anxiety and depression is in excess of $8 billion annually. There remains a significant market opportunity for new therapeutic approaches since currently available treatments are associated with several adverse side effects and variable efficacy. We believe that CRF antagonists have the potential to be a faster-acting alternative therapeutic with reduced side effect profiles, a significant market advantage in meeting the unmet needs of this large and growing patient population," said Gary A. Lyons, President and CEO of Neurocrine Biosciences.

"We look forward to working with Janssen to continue to develop new CRF antagonist compounds that will build significant market share and increase our franchise in this important therapeutic class," added Lyons.

CRF was first cloned and identified by Neurocrine co-founder, Dr. Wylie Vale and his colleagues at the Salk Institute. Neurocrine holds the patent rights to CRF receptors and has developed selective, potent, small molecule antagonists for these receptors. CRF functions as a neurotransmitter in the brain and plays a critical role in coordinating the body's responses to stress. The CRF1 receptor subtype largely mediates these effects. In preclinical models, selective CRF1 receptor antagonists block stress responses providing evidence that this novel mechanism may result in improved anti-anxiety and anti-depressant drugs. CRF1 antagonists have not shown evidence of sexual dysfunction or addictive properties in preclinical models. In addition some data suggest that CRF1 antagonists may have a more rapid onset of action compared to the currently marketed anti-depressants.

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, insomnia, stroke, malignant brain tumors, multiple sclerosis, obesity and diabetes.

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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, Inc.
Web site: http: //www.neurocrine.com
CONTACT: Elizabeth Foster or Paul Hawran of Neurocrine Biosciences, 619-658-7600