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Transcept Pharmaceuticals Announces Expected FDA Extension of Regulatory Review Period for Intermezzo(R)
Date:6/11/2009

included in this press release regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the timing of potential FDA approval of the Intermezzo(R) NDA and Intermezzo(R) being the first commercially available sleep aid in the United States in its target indication. Transcept may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Transcept makes, including risks related to: the opinion of the FDA on the sufficiency of the NDA to support marketing approval of Intermezzo(R); FDA review of the additional information recently provided by Transcept; the grant by the FDA and maintenance of exclusivity to Intermezzo(R) under Hatch-Waxman; commercial acceptance of Intermezzo(R), if approved; unforeseen expenses related to FDA approval, commercialization or the business of Transcept generally; Transcept dependence on third parties to manufacture Intermezzo(R); obtaining, maintaining and protecting the intellectual property incorporated into Intermezzo(R); and, if sought, the ability of Transcept to obtain additional funding to support its business activities. These and other risks are described in greater detail in the "Risk Factors" section of Transcept periodic reports filed with the SEC. Forward-looking statements do not reflect the potential impact of any future in-licensing, collaborations, acquisitions, mergers, dispositions
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