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Neurocrine Biosciences Reports Fourth Quarter And Year End 2012 Results
Date:2/8/2013

, multinational, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of elagolix in 875 women, age 18 to 49, with moderate to severe endometriosis-associated pain. Approximately 160 sites in the United States, Puerto Rico and Canada are conducting this study.

AbbVie is also currently conducting a Phase II study of elagolix for uterine fibroids to assess blood loss in women with heavy uterine bleeding due to such fibroids. AbbVie expects a Phase IIb study in uterine fibroids to commence in 2013.

VMAT2 UpdateThe Company is currently conducting two Phase IIb studies of its VMAT2 inhibitor NBI-98854.

The Kinect Study is a 120 subject, placebo-controlled, double-blind, parallel design, multiple dose, 12-week study assessing six-week dosing of NBI-98854 against placebo, followed by six weeks of open-label treatment with NBI-98854. The primary endpoint is the Abnormal Involuntary Movement Scale (AIMS) at the end of the first six weeks of dosing. The study will also incorporate a capsule formulation of NBI-98854. Top-line data from the placebo-controlled portion of this study is expected in the second quarter of 2013.

The Kinect 2 Study is a 90 subject, placebo-controlled, double-blind, parallel design, multiple dose, six-week study assessing NBI-98854 against placebo. The primary endpoint is the AIMS at the end of the six weeks of dosing. Top-line data from this placebo-controlled study is expected in the third quarter of 2013.

Additionally, the Company is conducting appropriate preclinical studies to support the advancement of NBI-98854 into clinical trials for individuals suffering from Tourette's syndrome.

The Company anticipates and end-of-phase-II meeting for NBI-98854 in tardive dyskinesia to be held with the FDA in the fourth quarter of 2013.

Conference Call and Webcast Today at 8:00 AM Eastern Time
Neurocrine will hold a live conference call and webcast today at 8:00 a
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SOURCE Neurocrine Biosciences, Inc.
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