Release Details

SAN DIEGO, Aug. 5 /PRNewswire/ -- Neurocrine Biosciences, Inc, (Nasdaq: NBIX) today announced that the Company has been issued U.S Patent No. 5,796,203 for nucleic acid sequence encoding CRF(2) receptors from the U.S. Patent and Trademark Office. In addition, Neurocrine is the exclusive licensee for issued U.S. Patent No. 5,728,545 which has been awarded to the Salk Institute for the nucleic acid sequence encoding the CRF receptor as well as Patent No. 5,464,757 for nucleic acid molecules encoding the CRF Binding Protein. Neurocrine now holds exclusive rights to U.S. patents relating to all known CRF receptors and CRF Binding Proteins.

Neurocrine's first CRF receptor antagonist (R121919) is completing Phase I clinical trials for anxiety and depression with partner Janssen Pharmaceutica. Janssen expects to advance this compound into Phase II clinical trials later this year.

Neurocrine is also developing CRF(1) receptor antagonists for stroke, seizures and head trauma. Preclinical studies demonstrating the neuroprotective effects of CRF receptor antagonist were presented at the International Symposium on Pharmacalogy of Cerebral Ischemia in Marburg, Germany on July 28,1998. Data presented at the meeting show that CRF(1) receptor antagonists reduce brain infarction in a preclinical model of middle cerebral artery occlusion (MCAO). These data taken with previous studies describing protective effects of CRF receptor agonists and antagonists in ischemic, traumatic, and excitotoxic brain insults suggest that selective CRF(1) receptor antagonists may have utility for the treatment of acute neurodegenerative conditions.

Neurocrine scientists have found in preclinical models that the CRF(2) receptor is present on neurons in the hypothalamus, where it mediates the effects of CRF and urocortin on food intake and on cerebral vessels, where it produces vasodilation. Based on this preclinical evidence, Neurocrine has established a program to develop selective CRF(2) small molecule receptor antagonists, which may be of therapeutic benefit for anorexia and migrane in addition to other central nervous system indications.

Dr. Wylie Vale and his colleagues at the Salk Institute first identified the structure of CRF and have cloned and characterized the CRF related known drug targets including the first CRF-Receptor and the CRF Binding Protein. Dr. Vale is also the Co-founder and Chief Scientist of Neuroscience at Neurocrine. Dr. Vale has been instrumental, in collaboration with Neurocrine scientists, in developing CRF small molecule receptor antagonists.

"The issuance of these patents is an important milestone in our neuroscience program. Neurocrine now has the exclusive rights to all known CRF receptors and the CRF binding protein, strengthening our leadership position in CRF technology. Our CRF receptor antagonists may offer a new generation of anxiolytics and antidepressants with an improved pharmacokinetic profile, which may potentially reduce the side effects associated with current therapeutics. We believe that our CRF technology may lead to a whole new class of compounds with the potential to more effectively treat the unmet medical needs of the growing neurological and psychiatric patient populations," said Gary A. Lyons, President and Chief Executive Officer.

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 the press release that relate to the development of potential products, including the expected date of entry into clinical trials are forward looking statements. Such forward lookng statements involve risks and uncertainties, including without limitation; that Neurocrine will not continue to maintain exclusive patent rights to all known CRF receptors and CRF binding proteins, and that compounds which demonstrate efficacy in pre-clinical studies may not prove to he effective for treatment in humans, that development candidates which have succesfu11y progressed through pre-clinical and early state clinical trials will not successfully proceed through later stage large scale clinical trials, that the regulatory clearances required for clinical testing manufacturing and marketing of products may not be received in a timely manner (or at all) and may have a potential adverse impact that competitive technologies and products, as well as the risk that Neurocrine may he unable to attract additional corporate collaborations or that existing collaborative partners may elect not to proceed with the development of a potential product. For a discussion of the 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 risks could differ materially from those indicated in the forward looking statements as a result of these and other factors.
SOURCE Neurocrine Biosciences, Inc.
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