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Neurocrine: Study Meets Primary Endpoint, Submission Of New Drug Application Planned For 2016

The following excerpt is from the company's SEC filing.

Company to Host Conference Call and Webcast Thursday, October 8

San Diego, CA, October 8, 2015 - Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced today that NBI-98854, a highly selective small molecule VMAT2 inhibitor, showed a statistically significant reduction in tardive dyskinesia during the six weeks of placebo-controlled treatment in the Kinect 3 clinical trial. This Phase III trial included moderate to severe tardive dyskinesia patients with underlying schizophrenia, schizoaffective disorder, bipolar or major depressive disorder.

The pre-specified prim ary efficacy endpoint was the change-from-baseline in the Abnormal Involuntary Movement Scale (AIMS) at Week 6 in the 80mg once-daily dosing group compared to placebo as assessed by central blinded video raters. The AIMS ratings at Week 6 for the 80mg once-daily NBI-98854 intention-to-treat (ITT) population was reduced 3.1 points (Least-Squares Mean) more than placebo (p<0.0001).

We are very pleased with the outstanding efficacy and side effect profile demonstrated by NBI-98854 in the Kinect 3 study. The efficacy data from this pivotal Phase III study completes our placebo-controlled dataset for NBI-98854 in tardive dyskinesia, said Kevin C. Gorman, President and Chief Executive Officer of Neurocrine. We will now turn our focus to completing the open-label safety portion of the studies in tardive dyskinesia patients and compiling the data for both doses of NBI-98854 to be included in the New Drug Application we intend to file with the FDA in 2016.

The results of this Kinect 3 study demonstrate the potential of NBI-98854 to be a safe and effective treatment for patients suffering from the debilitating effects of tardive dyskinesia and we look forward to sharing additional details of this important study at upcoming scientific meetings starting in mid-2016, said Christopher F. OBrien, Chief Medical Officer of Neurocrine. We want to thank the trial participants and investigators who contributed to this successful placebo-controlled portion of the Kinect 3 study and we look forward to continuing our work with them in the open-label safety assessment of NBI-98854 in patients suffering from tardive dyskinesia, as well as completing the initial Tourette syndrome study later this year.

In addition to the primary efficacy endpoint, the AIMS rating for the 40mg once-daily dose and the Clinical Global Impression of Change (CGI-TD) for both doses were also evaluated. The table below summarizes the results of the AIMS ratings and CGI-TD at Week 6 for both the ITT population and a preliminary pre-specified per-protocol (PP) population. The PP population excluded subjects whose plasma concentrations of NBI-98854 were below the lower limit of quantitation (i.e., not detectable). Given the timing of plasma samples collections and the pharmacokinetic profile of NBI-98854, it was determined that these subjects had not ingested the study drug.

40mg qd

p-value*

80mg qd

AIMS Difference from Placebo

Least-Squares Mean (ITT population)

0.0021

Least-Squares Mean (PP population)

0.0009

CGI-TD Difference from Placebo

0.0742

0.0560

0.0097

0.0122

Assessment of the significance of p-values based on pre-specified, fixed-sequence testing procedure

Safety Profile

During the six-week placebo-controlled treatment period NBI-98854 was generally well tolerated. The frequency of adverse events was similar...


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