Neurocrine Biosciences and Taisho Pharmaceutical Announce Agreement Restructuring
"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.
Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders. Our product candidates address some of the largest pharmaceutical markets in the world including insomnia, anxiety, depression, malignant brain tumors and peripheral cancers, diabetes mellitus, multiple sclerosis, irritable bowel syndrome, eating disorders, pain, stroke, and certain female health disorders. Neurocrine Biosciences, Inc. news releases are available through the Company's website via the Internet at http://www.neurocrine.com .
In addition to historical facts, this press release contains forward-looking statements regarding Neurocrine's development of NBI-6024 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 NBI-6024 development program as well as risks and uncertainties regarding Neurocrine's business and finances including, but not limited to, risk that Neurocrine's NBI-6024 program will not successfully proceed through Phase II clinical trials, that the trials intended to be pivotal will not be deemed sufficient for regulatory approval or that clinical trials will not show that NBI-6024 is effective in treating Type I diabetes; determinations by regulatory and governmental authorities; 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 December 31, 2001 and the quarterly report filed on Form 10-Q for the quarter ended June 30, 2002. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.
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SOURCE Neurocrine Biosciences, Inc.
Web site: http://www.neurocrine.com
CONTACT: Claudia Jones or Paul Hawran of Neurocrine Biosciences,
Inc., +1-858-658-7600