NEUROCRINE PLANS TO RESUBMIT INDIPLON NDA

Neurocrine Biosciences has announced plans to resubmit its new drug application (NDA) for indiplon capsules by the end of the second quarter. The decision to accelerate the resubmission is based on interactions with the FDA regarding further analyses of data previously submitted on indiplon, as well as reviews of this data with independent statistical, regulatory and clinical consultants. Neurocrine expects that the FDA will characterize the resubmission as Class 2, which has a targeted review timeline of six months.

The company's discussions with the FDA on the indiplon NDA have been focused on the actions necessary to provide a complete response to the agency's questions. The FDA requested that the resubmission include further analyses and modifications of analyses previously submitted to address questions raised by the agency in its initial review. The FDA also requested, and the company has completed, a supplemental pharmacokinetic/food-effect profile of indiplon capsules that includes several meal types. No other trials were requested for the resubmission.

The company has decided that it will not conduct an additional three-month safety and efficacy study as previously announced but rather direct resources to Phase IIIb/IV activities as well as to continue to evaluate indiplon for traditional sleep maintenance.

Neurocrine received an approvable letter from the FDA for its indiplon NDA in May 2006. In June Pfizer terminated its collaborative agreement with Neurocrine for the development of the drug.