CRF1 Receptor Antagonist for Depression and Anxiety 3/4/01 ?

Q.This trial is being conducted in 48 normal, healthy volunteers and is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics including endocrine profiles over a range of escalating doses. To date, the two dosing groups involving 16 subjects have completed treatment and initial kinetic evaluation indicate good and rapid absorption with no observable side effects or safety concerns. After successful completion of this study in February, a multiple dose escalating trial will be initiated to further evaluate the safety and endocrine profiles of this compound followed by Phase II studies in anxiety and depression.

A.Neurocrine's partnered CRF Receptor antagonist compound (NBI 37582) has achieved an important milestone and has been nominated for full scale development by partner Janssen Pharmaceutica (a subsidiary of Johnson & Johnson). NBI 37582 has been advanced to development status and is expected to move into Phase I clinical trials by 3rd Quarter 2001 following completion of GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices) studies. This will complete the research phase of Neurocrine's collaboration with Janssen Pharmaceutica. "It is our goal to remain the world leader in the CRF field. We are pleased with the progress we have made with our new second generation CRF receptor antagonist programs this year," said Gary Lyons, president & CEO of Neurocrine. "The Janssen program and our internal proprietary programs represent two independent programs for the discovery and development of novel therapeutics for the treatment of anxiety and depression and demonstrates our commitment to this field. It remains our strategy to advance several proprietary CRF compounds into clinical development so as to select the compound with the best safety and efficacy profile for definitive Phase II trials. Our research in this area has also expanded this year and has demonstrated utility of CRF antagonists in Irritable Bowel Syndrome, pain and neuro-protection." CRF was first identified and cloned by Neurocrine co-founder, Dr. Wylie Vale, and his colleagues at the Salk Institute. CRF functions as a neurotransmitter in the brain and plays a critical role in coordinating the body's response to stress. The CRF1 receptor subtype largely mediates these effects. In preclinical models, selective CRF1 receptor antagonists block stress-related responses providing further evidence that this novel mechanism may result in improved anti-anxiety and anti-depressant properties. In addition, some data suggests that CRF1 antagonists may have a more rapid onset of action and a reduced side effect profile compared to currently marketed anti-depressants. Neurocrine Biosciences is a neuroscience based research and development biopharmaceutical company focused on the development of therapeutic products in the areas of anxiety, depression, insomnia, malignant brain tumors, diabetes and multiple sclerosis. Neurocrine Biosciences Inc. news releases are available through the company's Web site via the Internet at http://www.neurocrine.com.

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