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Neurocrine Biosciences Reports Fourth Quarter and Year-End 2008 Results
Date:2/3/2009

ing agreement on a registration plan with the Food and Drug Administration (FDA).

The Company is also currently conducting two additional randomized placebo-controlled Phase IIb clinical trials. The primary clinical endpoint for both of these trials is a reduction in pelvic pain associated with endometriosis, utilizing a Numeric Rating Scale. The first Phase IIb trial includes the Company's selected commercial formulation tablet in two once daily doses, (150 mg and 250 mg); this trial has completed the initial three-month placebo controlled dosing regimen and continues with an additional three-months of elagolix treatment. The Company will report top-line results from the first three months of treatment at the end of the first quarter of 2009. The second trial is a four arm comparator trial of two once daily doses of elagolix (150 mg and 250 mg), placebo or leuprolide depot. This trial is being conducted in Central Eastern Europe and is currently enrolling. Top-line data from this 3-month double-blind trial of approximately 180 patients is expected to be available in the third quarter of 2009.

The Company expects to hold an end of Phase II meeting with the FDA in late 2009.

Neurocrine is also investigating the potential of certain GnRH antagonists in treating other hormone-dependent diseases in men's and women's health.

Corticotropin Releasing Factor (CRF1) Receptor Antagonists for Anxiety/Depression and IBS

The CRF collaboration between Neurocrine and GSK has identified multiple unique high affinity and selective antagonists for the CRF1 receptor that are currently in clinical development for mood disorders and irritable bowel syndrome (IBS).

In a double-blind, randomized, placebo controlled, multiple dose study to evaluate the safety and efficacy of the CRF1 receptor antagonist, 876008, in approximately 130 patients with IBS, no statistically signif
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SOURCE Neurocrine Biosciences, Inc.
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