Release Details

SAN DIEGO, March 2 /PRNewswire/ -- Neurocrine Biosciences (Nasdaq: NBIX) today announced that results of its Phase II/III trial with the neurosteroid, DHEA, for Alzheimer's disease, did not demonstrate a difference in efficacy between patients treated with DHEA versus placebo despite suggestion of efficacy from a previously completed 60 patient Phase II trial. Based on these results, Neurocrine will not pursue further development of DHEA. There were no clinically significant differences in adverse events reported between the drug treated group versus placebo.

Neurocrine in-licensed DHEA for clinical investigation in May 1996 from the Beckman Research Institute of the City of Hope. The program for the development of DHEA was fully funded by Neurocrine's Canadian affiliate Neuroscience Pharma, Inc. (NPI) which was established in March 1996 to fund the clinical development of DHEA for Alzheimer's disease as well as to conduct discovery research in neurogenomics. NPI will continue to fund the neurogenomics program.

"In light of our previous Phase II trial and various academic clinical programs which have suggested efficacy for DHEA in numerous indications including Alzheimer's disease, we designed a trial to definitively answer the question of efficacy," said Gary A. Lyons, President and CEO of Neurocrine Biosciences. "This trial was well-designed and conducted in approximately 40 medical centers in eight countries around the world providing us with a conclusive answer. We will focus our expertise and resources used on this program to advance our five existing clinical programs," added Lyons.

The Company's CRF receptor antagonist is currently in Phase II clinical development with its partner, Janssen Pharmaceutica, for anxiety/depression. In addition, 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 Ib trial with NBI-34060 for insomnia. Neurocrine recently received approval from the Medicines Control Agency (MCA) in the United Kingdom to begin a Phase I trial with a second APL compound (NBI-6024) for diabetes. The Phase I trial is expected to begin in March 1999.

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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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
CONTACT: Elizabeth Foster or Paul Hawran of Neurocrine Biosciences, 619-658-7600; or Media: Justin Jackson of Burns McClellan, 212-213-0006