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Transcept Pharmaceuticals Receives Complete Response Letter from FDA on Intermezzo(R) New Drug Application
Date:10/28/2009

hese forward-looking statements, and claims the protection of the safe harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, the sufficiency of data submitted and data that may be generated and submitted in support of the NDA for Intermezzo® to receive FDA approval for its intended indication, including whether or not additional clinical or non-clinical studies will be required to obtain FDA approval; the timing and potential outcome of regulatory decisions by the FDA on the NDA for Intermezzo®; the commitment of Transcept to make Intermezzo® available to insomnia patients; and the potential for Intermezzo® to be the first prescription sleep aid specifically approved by the FDA for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, whether additional data exists or can be generated from existing or new clinical studies to demonstrate sufficiently to the FDA that Intermezzo® would not present an unacceptable risk of residual effects, including residual effects that impair next day driving ability; whether Transcept can sufficiently demonstrate to the FDA that it can reduce dosing errors in the middle of the night or that dosing errors will not lead to unacceptable next day residual effects; FDA decisions on the sufficiency of other data submitted in support of the Intermezzo® NDA to receive approval for its intended indication and any further delays in, and the final form of, any FDA approval of Intermezzo®; a decision by Purdue to terminate the Collaboration Agreement, even if the Intermezzo® NDA is approved; obtaining and maintaining Hatch-Waxman exclusivity for Intermezzo®
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SOURCE Transcept Pharmaceuticals, Inc.
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