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Neurocrine Biosciences Reports First Quarter 2008 Results
Date:4/30/2008

mpact of 252 Fully Q3 08

period with elagolix elagolix on bone enrolled

and DMPA active mineral density

comparator plus using DXA scan

additional long-term 2. Dysmenorrhea and

safety assessments pelvic pain

post treatment

0702 Placebo-controlled Dysmenorrhea and 150 Enrolling 1H 09

trial with 2 doses pelvic pain

of optimized assessed with

formulation tablet modified endpoints

0703 Placebo-controlled Dysmenorrhea and 180 Initiated 1H 09

trial with 2 doses pelvic pain

of elagolix and assessed with

leuprolide depot modified endpoints

comparator

The Company completed enrollment in December 2007 of a Phase IIb study in which patients with endometriosis will be treated over a 6-month period. This multi-center, randomized, double-blind, study includes three treatment groups, with two doses of elagolix, 150 mg once a day and 75 mg twice daily, and an active comparator, Depo-Provera(R). In addition to confirming the effect of elagolix on endometriosis symptoms, this study is designed primarily to assess the impact of longer term treatment on bone mineral density as measured by DXA scan at the conclusion of dosing and at 6-months and 12-months post-treatment. Topline results from the 6-month treatment period are expected in the third quarter of 2008. The study will continue after the treatment period for DXA scans and safety assessments. The 6-month results, together with data from the other Phase II studies, will be the basis for securing agreement on a registration plan with the FDA.

The Company is also currently conducting two additional randomized placebo controlled Phase II clinical trials. The clinical endpoints for both of these trials are a reduction in pelvic pain associated wit
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SOURCE Neurocrine Biosciences, Inc.
Copyright©2008 PR Newswire.
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