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Neurocrine Biosciences Reports Second Quarter 2014 Results
Date:8/6/2014

hare-based compensation expense.

General and administrative expenses increased from $3.4 million for the second quarter of 2013 to $4.2 million for the second quarter of 2014.  For the six months ended June 30, 2014 general and administrative expenses were $8.4 million, compared to $6.8 million for the first half of 2013.  The increase in general and administrative expense is primarily due to higher share-based compensation expense.

Pipeline HighlightsVMAT2 UpdateThe Company recently held an End-of-Phase II meeting with the FDA for its VMAT2 inhibitor, NBI-98854.  The FDA reviewed the current data package and clinical development plan for NBI-98854 and commented on the overall proposal for Phase III development to support the registration of NBI-98854 in the United States as a treatment for tardive dyskinesia.  Based on the results of this meeting and the related minutes, the Company will conduct a single placebo-controlled Phase III study of NBI-98854, the Kinect 3 study. The Kinect 3 study, along with the previous efficacy studies of NBI-98854, will complete the placebo-controlled clinical efficacy evaluation of NBI-98854 in tardive dyskinesia. The primary endpoint in the Kinect 3 study will be the mean change from baseline in the Abnormal Involuntary Movement Scale (AIMS) as assessed by blinded central raters.  The Kinect 3 study will include approximately 240 subjects randomized to either placebo, once daily 40mg of NBI-98854 or once daily 80mg of NBI-98854 for 6 weeks of placebo-controlled dosing followed by an extension of active dosing through Week 48.  The Company also intends to conduct a separate one-year open-label safety study of NBI-98854 to support the anticipated 2016 filing of a New Drug Application in tardive dyskinesia.

The Company is also expecting to submit an Investigational New Drug application for NBI-98854 in Tourette syndrome later this month and plans to commence the clinical progr
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SOURCE Neurocrine Biosciences, Inc.
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