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SAN DIEGO, Jan. 6 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that it has signed an exclusive agreement with Taisho Pharmaceutical Co. LTD providing Taisho an option to obtain European and Asian commercialization rights for Neurocrine's altered peptide ligand (APL) for diabetes (NBI-6024). Neurocrine will retain all rights in the rest of the world, including North America. Taisho and Neurocrine will form a steering committee to coordinate the worldwide development of NBI 6024. The approximate value of the collaboration will be $45 million, which includescertain development and regulatory milestones, and reimbursement of 50% of the worldwide development expenses. In addition, Neurocrine will receive royalties on product sales in Europe and Japan.

NBI-6024 is based on Neurocrine's proprietary APL technology which was discovered and developed by Neurocrine scientists and its co-founder, Dr. Larry Steinman, M.D., Professor, Department of Neurology and Neurological Sciences, Stanford University School of Medicine. NBI-6024 is currently in Phase I clinical trials in diabetic patients to evaluate the safety profile of this compound for the eventual treatment of insulin-dependent diabetes mellitus (IDDM). Phase I trials are expected to be completed in first half 2000.

"We believe Neurocrine scientists and scientific collaborators have world renown expertise in this field which will allow Taisho to commercialize a very novel therapeutic that may improve treatment and quality of life for many patients diagnosed with diabetes each year. We look forward to a successful collaboration," said Akira Ohira, Executive Vice President of Taisho Pharmaceuticals.

"Taisho is an excellent partner with proven experience in diabetes. Diabetes is one of the focus areas of Taisho's R&D and is expanding the product portfolio in the diabetes area," said Gary Lyons, President and CEO of Neurocrine Biosciences, Inc. "This new partnership will provide Neurocrine with the financial resources necessary for U.S. development while capturing significant value for the compound while retaining all rights to the U.S. market."

According to Jean-Francois Bach, M.D., Professor and Head, Department of Clinical Immunology, Hospital Necker, "New treatments, like the altered peptide ligand (APL) approach may offer great therapeutic potential in the intervention of this devastating autoimmune disease." Dr. Bach is a worldwide leader in clinical autoimmune disease research, who, for numerous years, has investigated the pathogenesis, genetics, prevention and treatment of IDDM.

According to the American Diabetes Association, there are 15.7 million people, or 5.9% of the population in the United States who have diabetes with incidences increasing. While an estimated 10.3 million patients have been diagnosed, the rest are not aware they have the disease. The National Diabetes Foundation concur that IDDM represents 5-10% of all diagnosed cases of diabetes or approximately 1.5 million recognized Type 1 diabetics in the U.S. and Europe. A significant additional market for APL Diabetics is the Type 1.5 diabetic patient. Recent refinements in diagnostic clinical metabolic assays for IDDM suggest that 5-10% of patients previously diagnosed as Type 2 diabetics may actually have IDDM. These misdiagnosed patients will substantially increase the market size for patients who could potentially benefit from immune-specific therapeutic agents designed for the prevention of IDDM. Approximately 3.2 million people in the U.S. and Europe would be included in this group.

Background on Neurocrine's APL Technology for Diabetes

In the case of IDDM the beta-islet pancreatic cells, which are responsible for the production of insulin, are the targets for immune mediated destruction. Working closely with leading diabetologists, Neurocrine scientists have engineered one of the dominant pancreatic antigens so that it is recognized by the pathogenic immune cell as being foreign. In addition, this APL has been shown in preclinical models to elicit a protective immune response by down regulating the immune-mediated destructive process, thereby preserving the beta-islet cell and their producing capability.

In preclinical models, Neurocrine's APL clinical compound also has been shown to reduce the incidence of diabetes. In addition, immune cells from diabetic patients vigorously react to the region of insulin from which Neurocrine's APL was developed whereas immune cells from non-diabetic patients do not recognize the antigen. These data indicate that the APL has the potential to intervene in the disease process in humans. The preclinical data suggest that this therapeutic intervention, if administered prophylactically, may have the potential to prevent the onset of diabetes in those patients who are at high risk, such as first degree relatives of patients with IDDM. In addition, there is the potential to intervene in newly diagnosed patients or patients who still have residual intact beta-islet cells function by preventing further destruction, and preserving endogenous insulin production, thereby mitigating disease progression. When combined with the commercialization of novel genetic screening and immune function diagnostic products for early identification of IDDM, this strategy will address both the primary cause and the development of a true cure for IDDM.

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.

Taisho, headquartered in Tokyo, is the top pharmaceutical company in over-the-counter healthcare products in Japan and continues to expand its sales and research, both internally and through collaborations in the prescription drug field. Taisho reported approximately 270 billion yen in this year's sales forecast (April, 1999 -- March, 2000). Taisho is focused on contributing to the maintenance and improvement of consumers' health by creating and providing quality drugs, related health care products and information services that satisfy consumers with various lifestyles. Taisho is actively strengthening its research and development of new products in the prescription drug field and considers collaborations with biotechnology companies as part of such activities.

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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.
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