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

To: scaram(o)uche who wrote (519)	2/17/2000 10:01:00 AM
From: Torben Noerup Nielsen	Read Replies (1) \| Respond to of 1834

Anyone else been watching NBIX this morning? I'm looking for extra toothpicks to keep my eyes open just so I can see each blow as it happens.... Thanks, Torben

To: scaram(o)uche who wrote (519)	3/8/2000 9:09:00 AM
From: scaram(o)uche	Read Replies (1) \| Respond to of 1834

Wednesday March 8, 7:31 am Eastern Time Company Press Release SOURCE: Neurocrine Biosciences, Inc. Neurocrine Biosciences, Inc. Announces Initiation of the First Of Fourteen Clinical Trials in Insomnia to Be Completed in 2000 Completion of Phase II Trials Will Lead To Pivotal Phase III Trials in Early 2001 SAN DIEGO, March 8 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX - news) reported that based on the positive results of NBI-34060 in a Phase II trial in which a robust sedative hypnotic effect was demonstrated, the company has initiated the first of fourteen clinical trials to be completed in 2000. These clinical trials are designed to define the safety, efficacy and dose response of NBI-34060 in a variety of different populations and to differentiate NBI-34060 from currently marketed therapies. These trials will involve approximately 600 subjects and are designed to provide sufficient data to quickly proceed into pivotal Phase III trials in early 2001. ``NBI-34060 works through a proven mechanism and has been shown to be more selective than leading non-benzodiazepines. It promotes rapid sleep onset with fewer next day residual effects,' said Dr. Thomas Roth, Chief, Division Head, Sleep Disorders and Research Center, Henry Ford Hospital. ``These trials will evaluate NBI-34060 in comprehensive clinical comparative safety and efficacy studies to identify a more ideal sedative for wide spread usage.' NBI-34060 was shown in a Phase II trial completed late in 1999, to be a robust sedative hypnotic as demonstrated by a highly statistically significant and clinically relevant effect in inducing sleep when compared to placebo. The Phase II clinical trial was a randomized, double blinded, placebo controlled, multi-center Phase II clinical trial of NBI-34060 in 228 subjects with transient insomnia. The study was conducted in a sleep laboratory setting employing objective polysomnographic assessments. The safety findings indicate that NBI-34060 was safe and well tolerated at doses up to 30 mg. There were no serious adverse events reported in this clinical trial. Overall there was a low incidence of adverse effects, which was comparable to that observed in the placebo group with no residual next day hangover effects. The data confirmed that NBI-34060 is safe and effective in helping subjects with transient insomnia achieve rapid sleep induction without next day residual effects associated with most currently marketed sleep hypnotics. The results indicated statistical significance for the primary clinical endpoint of Latency to Persistent Sleep (LPS), the required regulatory endpoint for approval. In this study, which enrolled 228 transient insomnia subjects, those subjects receiving NBI-34060 the mean time to LPS was 16 minutes compared to 34 minutes in the placebo group (p less than .001). In addition, the median time for LPS indicated that a majority of subjects in the treated group fell asleep within 9 minutes as compared to 23 minutes in the placebo group. 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, insomnia, stroke, malignant brain tumors, multiple sclerosis, obesity and diabetes. Neurocrine Biosciences, Inc. news releases are available free of charge through 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 prnewswire.com. In addition to historical facts, this press release may contain 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 NBI-34060 development programs including, but not limited to, risks and uncertainties associated with, or arising out of, clinical development of products including risk that 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, 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, 1998. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof. SOURCE: Neurocrine Biosciences, Inc.