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Transcept Pharmaceuticals Submits New Drug Application for Intermezzo(R) for Treatment of Middle-of-the-Night Awakenings
Date:10/1/2008

termezzo(R) 3.5 mg or placebo at home, at the time they awakened in the middle of the night and had difficulty returning to sleep. This Phase 3 clinical trial also met its primary endpoint of significantly reducing the time required for the patient to return to sleep versus placebo. After dosing and returning to sleep, patients in the outpatient study who were randomized to Intermezzo(R) also reported fewer subsequent awakenings and less time awake during the remainder of the night. There was no evidence of next day residual sedative effects after middle of the night use of Intermezzo(R) versus placebo.

Glenn A. Oclassen, President and Chief Executive Officer of Transcept, commented, "The submission of the Intermezzo(R) NDA achieves a key milestone for the Transcept team and advances our efforts to gain FDA approval for Intermezzo(R) as the first sleep aid developed specifically to be used in the middle of the night when patients awaken and have difficulty returning to sleep. This NDA submission is the latest in a series of transformative events for Transcept, which have recently included our execution of a definitive merger agreement with Novacea, Inc. Assuming that this proposed merger closes near the end of 2008, Transcept is expected to begin 2009 with an estimated cash balance of $88 to $92 million, which we believe will enable us to carry out our plan to successfully commercialize Intermezzo(R)."

Middle of the Night Awakenings & Intermezzo(R)

According to a recent independent study, conducted by Dr. Maurice Ohayon of the Stanford Sleep Epidemiology Research Center, middle of the night awakening is the most frequently reported insomnia symptom. This study estimates that 35% of American adults experience a middle of the night awakening at least three times per week (Journal of Psychiatric Research, in press).

All of the most commonly prescribed sleep aids are designed to produce approximately seven to eight hours of sleep, and can be
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SOURCE Transcept Pharmaceuticals, Inc.
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