Release Details

SAN DIEGO, July 20 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that the Data and Safety Monitoring Board (DSMB) for MSP771 recommended that the administration of the drug be stopped to allow Novartis, its Steering Committee and advisors to analyze all of the available data. According to the DSMB, "the stated purpose of the current Phase II trial with MSP771 in patients with multiple sclerosis (MS) to evaluate safety, tolerability and effect on MRI lesion parameters has been accomplished relative to the risks involved, even though all of the patients have not received all of their scheduled doses of study medication. The team remains blinded but understands this to mean that sufficient data on the study of the different doses tested are now available to make a decision on the future of the clinical program for MSP771." The analysis of the results should be completed by year-end 1999.

Novartis, in a letter to clinical investigators noted that "systemic hypersensitivity-type reactions have been reported." Novartis goes on to say that, "These reactions were self-limited and, while unwanted, represent a pharmacologic response that illustrates that MSP771 is indeed producing an immunologic effect. The objective of MSP771 treatment is to generate an immunologic response that will modify the autoimmune disease without producing hypersensitivity. The data from this trial will help to define the dose-regimen that will achieve that objective and will allow us to make the best possible decisions in designing future studies with MSP771."

The primary endpoint of the Phase II program is the progression or regression of lesions in the brain of MS patients as measured by Magnetic Resonance Imaging (MRI). A secondary endpoint is the generation of a protective immune response. The study was designed to include 144 patients in four treatment arms (50, 20 and 5mg. vs. placebo) to receive weekly subcutaneous injections over a period of 4 months. The trial is fully enrolled. Approximately 50% of patients completed the full treatment regimen with 8-10% of patients reporting hypersensitivity-type reactions, which is still under investigation. As defined in the protocol, all 144 patients treated with MSP771 will be followed to establish a complete safety and efficacy database.

As previously disclosed Neurocrine will reacquire the rights to MSP771 from corporate partner Novartis in January 2000. While Novartis previously elected not to participate further in the development of the product because of prioritization of internal resources, they will fulfill their obligation to fund development costs related to the existing Phase II clinical trials through January 2000.

"Early analysis of the Phase II study will present an opportunity to accelerate our analysis of the dose effect and dosing frequency for future clinical development of MSP771. This preliminary information will also allow us to entertain corporate partnering discussions for funding purposes ahead of schedule to make the transition from Novartis' support," said Gary A. Lyons, President and Chief Executive Officer of Neurocrine Biosciences.

Including MSP771 for MS, Neurocrine has five programs in clinical development. The Company's CRF receptor antagonist is currently in Phase II clinical development with its partner, Janssen Pharmaceutica, for anxiety/depression. Neurocrine is also conducting a Phase II trial with NBI-3001 for glioblastoma (malignant brain tumor) and NBI-34060 for insomnia. Neurocrine also has commenced a Phase I clinical program with NBI-6024 for diabetes.

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.

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.

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
Company News On-Call: http: //www.prnewswire.com/comp/604138.html or fax, 800-758-5804, ext. 604138
CONTACT: Elizabeth Foster or Paul Hawran of Neurocrine Biosciences, 619-658-7600