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

To: Miljenko Zuanic who wrote (948)	6/25/2002 6:27:52 AM
From: smh	Read Replies (1) \| Respond to of 1834

Tuesday June 25, 6:01 am Eastern Time Press Release SOURCE: Neurocrine Biosciences, Inc. Neurocrine Biosciences Initiates Final Phase III Clinical Trial With Indiplon-IR (Immediate Release) Company on Schedule With Six of Eight Planned Phase III Trials Underway SAN DIEGO, June 25 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX - News) announced today that it is initiating the final pivotal Phase III clinical trial with indiplon-IR (Immediate Release). The Company is now conducting six of eight planned Phase III clinical trials with indiplon IR and MR (Modified Release) and expects to initiate the remaining Phase III clinical trials with indiplon-MR this year. According to the clinical program agreed upon by the Food and Drug Administration (FDA) at the Company's end of Phase II meeting, Neurocrine will be conducting five Phase III clinical trials with indiplon-IR and three Phase III trials with indiplon-MR in a total of approximately 3500 patients overall to support market registration of indiplon for short term and long term treatment in adult and elderly patients with Primary (Chronic) or Transient Insomnia. The Company expects to file a New Drug Application (NDA) for both formulations with the U.S. FDA at the end of 2003. The clinical program for indiplon will be one of the largest and most comprehensive evaluations of a therapeutic agent for insomnia, encompassing well over 5000 patients, and addressing the multiple needs of patients who suffer with insomnia. The final Phase III trial with indiplon-IR is a randomized, double-blind, placebo-controlled, outpatient, multi-center Phase III clinical trial to assess the efficacy and safety of two dose levels of indiplon-IR in approximately 360 elderly patients with Primary (Chronic) Insomnia. The primary endpoint for this study is Latency to Sleep Onset (LSO) as measured by patient self reported outcomes. Secondary endpoints will evaluate sleep quality and next day effects. Patients will be evaluated over an initial period of two weeks followed by a subsequent period of six months. This trial is being conducted at approximately 40 centers in North America. "We are conducting Phase III clinical trials with indiplon-IR and MR in approximately 1000 elderly patients overall based on our recent positive Phase II results with both formulations in this target patient population. We plan to initiate the remaining Phase III trials with indiplon-MR also in elderly patients this year. The final Phase III trial with indiplon-IR is significant in that patients will continue to be followed as an extension of this trial to gather long term safety data in the elderly patient population as part of our NDA package," said Henry Pan, M.D. Ph.D., Executive Vice President of Clinical Development and Chief Medical Officer for Neurocrine Biosciences. "We are on track to complete enrollment in our five Phase III clinical trials with the IR formulation and the majority of our Phase III trials with the MR formulation by year end 2002. We are also meeting our schedule to file the NDA in both formulations at the end of 2003," added Pan. Indiplon is a non-benzodiazepine that acts on a specific site of the GABA- A receptor. It is through this mechanism that the currently marketed non- benzodiazepine therapeutics also produce their sleep-promoting effects. Insomnia is a prevalent neurological disorder in the United States with about one-half of the adults surveyed (51%) report having experienced one or more symptoms of insomnia at least a few nights a week in the past year according to the National Sleep Foundation (NSF) 2001 report. In fact, about three in ten (29%) say they have experienced insomnia every night or almost every night. Population-based surveys have shown that up to 40 percent of people aged 65 and over are either dissatisfied with their sleep, or report trouble sleeping. Twelve to 25 percent of these patients complain of persistent insomnia. In the U.S., the elderly make up 13 percent of the overall population, but receive 35 to 40 percent of prescriptions written for sedative hypnotics. Despite this widespread prevalence, insomnia remains a disorder with high unmet medical needs, including the ability to maintain sleep throughout the night without next-day residual effects.