To: Miljenko Zuanic who wrote (988 ) 10/14/2002 7:34:39 AM From: Icebrg Read Replies (1) | Respond to of 1834 Neurocrine Biosciences and Taisho Pharmaceutical Announce Agreement Restructuring Monday October 14, 7:30 am ET SAN DIEGO, Oct. 14 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX - News) announced today the restructuring of its exclusive agreement with Taisho Pharmaceutical Co., Ltd. The original agreement signed in January 2000, provided Taisho an option to obtain European and Asian commercialization rights for Neurocrine's altered peptide ligand (APL) (NBI-6024) for diabetes mellitus with Neurocrine retaining all rights in the rest of the world including North America. In July 2000, Taisho exercised its option to the European and Asian rights. The collaboration was then expanded in December 2000, providing Taisho exclusive rights to North America and countries outside of Europe and Asia. The restructuring of this agreement now allows Neurocrine to reacquire and assume all rights outside of Japan. "Our agreement with Taisho was amended in April of this year allowing for this potential restructuring. We are interested in securing commercial rights to NBI-6024 especially in the United States and are now able to move forward with this plan," said Gary Lyons, President and CEO of Neurocrine Biosciences. Neurocrine has completed four Phase I trials and has one ongoing Phase I/II safety and dose escalating clinical trial in approximately 120 diabetic patients overall. Currently Neurocrine is conducting an international Phase IIb clinical trial of NBI-6024 in approximately 170 adult and adolescent patients with new onset Type I diabetes. A second Phase IIb trial in newly diagnosed Type I diabetics in approximately 200 patients is scheduled to begin in the U.S. later this year or early next year. Neurocrine researchers recently reported the therapeutic activity of NBI-6024 in an animal model of Type I diabetes (Diabetes 51:2126-2134, 2002). In this publication, researchers demonstrated that the APL was capable of controlling or delaying the onset of diabetes, even when administered shortly before the onset of diabetes. "Given these preclinical data, and our growing experience with the safety of this peptide, we are encouraged with our progress of treating this devastating disease," said Dr. Paul Conlon, Vice President of Biology, Neurocrine Biosciences. 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.