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Biotech / Medical : Neurocrine Biosciences (NBIX) -- Ignore unavailable to you. Want to Upgrade?


To: Miljenko Zuanic who wrote (988)10/9/2002 6:58:54 PM
From: Miljenko Zuanic  Read Replies (1) | Respond to of 1834
 
Received respond from NBIX regards the article in JCI.

""We have no evidence of anaphylaxis in any of the preclinical studies, some out as long as one year, that we have done with the APL, including NOD mice. Moreover, in over 100 patients treated with the NBI-6024, we have no evidence of hypersensitivity and/or anaphylaxis. The diabetes community has safely administered the protein insulin for over twenty years subcutaneously, with little or no evidence for anaphylaxis.""

Thanks, Paul and Conlon.

I have no reason not to believe them. Also, as they mentioned, appropriate approach dealing with proteins and proteins fragments are warranted.

Miljenko



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.