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Neurocrine Announces Positive Results of VMAT2 Inhibitor NBI-98854 in Kinect 2 Study
Date:1/6/2014

SAN DIEGO, Jan. 6, 2014 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that NBI-98854, a small molecule VMAT2 inhibitor, showed a statistically significant and clinically meaningful reduction in tardive dyskinesia symptoms in the Phase IIb Kinect 2 study. The pre-specified primary endpoint was the change-from-baseline in the Abnormal Involuntary Movement Scale (AIMS) at Week 6 as assessed by central blinded video raters.

At Week 6, AIMS scores were reduced by 2.6 points in the NBI-98854 intention-to-treat (ITT) group compared to a reduction of 0.2 points in the placebo arm (p<0.001). Additionally, the responder rate (>= 50% improvement from baseline) was 49% in the NBI-98854 ITT group compared to 18% in placebo (p=0.002). In the per-protocol (PP) group AIMS scores were reduced by 3.3 points for those subjects taking NBI-98854 (p<0.001), with a corresponding responder rate of 59% (p<0.001).

"The profound response in this Kinect 2 study demonstrates the potential of NBI-98854 as both a safe and highly effective treatment for patients suffering from tardive dyskinesia," said Christopher F. O'Brien, Chief Medical Officer of Neurocrine Biosciences. "It is clear from these results that the use of blinded central AIMS raters coupled with the ability to titrate up to 75 mg of NBI-98854 were both critical to the success of this trial."

The improvement in Week 6 AIMS was also corroborated by the Clinical Global Impression–Tardive Dyskinesia (CGI-TD). Treating clinicians determined that approximately 67% of the subjects taking NBI-98854 were "much improved" or "very much improved" at Week 6 compared to only 16% of the placebo subjects (p<0.001) in this pre-specified key secondary efficacy endpoint.

"The data from this Kinect 2 study allows us to submit an
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SOURCE Neurocrine Biosciences, Inc.
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