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

nings with difficulty returning to sleep."

About Intermezzo(R)

Intermezzo(R) Phase 3 clinical trials have been completed and, on September 30, 2008, Transcept submitted an NDA to the FDA, which was accepted for filing and assigned a PDUFA date of July 30, 2009. On June 10, 2009 Transcept received notice that the FDA would require up to an additional three months to complete its review of the Intermezzo(R) NDA. Under the revised timeline, Transcept now anticipates action from the FDA on the NDA on or before October 31, 2009.

If approved within the anticipated time frame, Intermezzo(R) will be the first commercially available sleep aid designed specifically for use in the middle of the night when patients awaken and have difficulty returning to sleep. As part of the NDA submission, Transcept requested that the FDA grant three years of Hatch-Waxman marketing exclusivity to Intermezzo(R). Transcept is also actively pursuing patents to cover Intermezzo(R) in the United States and key non-U.S. markets.

About Transcept

Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in neuroscience. On January 30, 2009, Transcept completed a merger with Novacea, Inc. As part of the transaction, Novacea changed its name to "Transcept Pharmaceuticals, Inc." and its NASDAQ ticker symbol to "TSPT." For further information, please visit the company's website at: http://www.transcept.com.

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts,
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SOURCE Transcept Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
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