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

End of Phase II meeting request as well as finalize the initial draft of a Phase III protocol, both of which we anticipate filing with the FDA in the first half of 2014," said Kevin C. Gorman, President and Chief Executive Officer of Neurocrine. "Our Phase II studies of NBI-98854 have served to define the study population, elucidate the primary endpoint, refine our dosing regimen and provide the necessary efficacy and safety data to enable pivotal studies."

The pre-specified statistical analysis plan included three data sets: a safety set (all subjects with at least one dose), an ITT set (all subjects who had an AIMS assessment at Week 6) and a PP set (all ITT subjects except those with no detectable drug levels at the evaluation time point). The table below summarizes the primary endpoint, LS Mean change-from-baseline AIMS, for both the ITT and PP populations at Week 6, as well as the responder analyses.Week 6PlaceboNBI-98854p-valueAIMS Change from BaselineBaseline AIMS

7.9

8.0

-LS Mean AIMS ANCOVA (ITT)

-0.2

-2.6

<0.001LS Mean AIMS ANCOVA (PP)

-0.3

-3.3

<0.001Responder Rate (ITT)*

18%

49%

0.002Responder Rate (PP)*

18%

59%

<0.001* a responder is defined as 50% or greater reduction in AIMS

The table below summarizes the key secondary endpoint, CGI-TD, for both the ITT and PP populations at Week 6.Week 6CGI-TDPlaceboNBI-98854p-valueLS Mean Score (ITT)

3.1

2.2

<0.001LS Mean Score (PP)

3.1

2.2

<0.001Responder Rate (ITT)*

16%

67%

<0.001Responder Rate (PP)*

16%

68%

<0.001*a responder is defined as "much improved" or "very much improved" (a "2" or "1", respectively) on the CGI-TD.  A "4" on the CGI-TD indicates "no change"

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SOURCE Neurocrine Biosciences, Inc.
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