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Neurocrine Biosciences Reports Third Quarter 2009 Results
Date:10/28/2009

ssessment of this modified scale over a two month treatment period of 150 mg elagolix, followed by twenty weeks of open-label treatment.

The blinded baseline data from the initial subjects screened for the Daisy Petal Study (0901) indicate that the modified daily non-menstrual pain scale reflects a wider dynamic range of pain scores which was lacking in the previous daily non-menstrual pelvic pain scale. This should allow for detection of treatment difference between elagolix and placebo for non-menstrual pain in the study population. The mean baseline score using the previous scale in the Lilac Petal Study (0702) was 0.83 (using the 0-3 scale on non-menstrual days), while preliminary Daisy Petal Study (0901) data with the new scale demonstrate a mean baseline score of approximately 1.5 (using the 0-3 scale on non-menstrual days), in the initial group of subjects recruited. Encouraged by the wider dynamic range of this modified scale, the Company has proposed a modest increase in the number of subjects for enrollment. This essentially moves the trial from a directional characterization of the endpoint (i.e., to estimate sample size for a Phase III trial) to a trial powered to provide statistical significance of the new non-menstrual pain endpoint versus placebo. The Company expects top-line data from the Daisy Petal Study (0901) in the second quarter of 2010.

"We are pleased with the outcome of the Type C meeting with the FDA," said Chris O'Brien, Chief Medical Officer. "Given the dynamic range of the daily non-menstrual pain endpoint in our baseline assessments, we were able to quickly estimate the appropriate sample size needed to assess this endpoint for statistical significance, and made the decision to increase our patient population accordingly."

The Tulip Petal Study (0703) has completed subject randomization (n=174) and treatment through Week 12 in Central Eastern Europe. This study is designed as a randomized, double-blind,
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SOURCE Neurocrine Biosciences, Inc.
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