Transcept Pharmaceuticals to Present at the BioCentury Thomson Reuters Newsmakers...

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Wed Sep 2, 2009 4:35pm EDT

Transcept Pharmaceuticals to Present at the BioCentury Thomson Reuters
Newsmakers in the Biotech Industry Conference on September 16, 2009



RICHMOND, Calif., Sept. 2 /PRNewswire-FirstCall/ -- Transcept Pharmaceuticals,
Inc. (Nasdaq: TSPT) today announced that it will present at the BioCentury
Thomson Reuters Newsmakers in the Biotechnology Industry Conference on
Wednesday, September 16, 2009 at 11:00 am EDT.

A live audio webcast and replay of the presentation will be available on the
investor webpage at www.transcept.com.

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.  The most advanced Transcept
product candidate is Intermezzo(R) (zolpidem tartrate sublingual tablet),
which is currently being reviewed by the U.S. Food and Drug Administration
(FDA) as a prescription sleep aid for use in the middle of the night at the
time a patient awakens and has difficulty returning to sleep. October 30, 2009
is the PDUFA target date for the FDA to take action on its review of the
Intermezzo(R) NDA.  Transcept and Purdue Pharmaceutical Products, L.P. have
entered into a collaboration agreement for the development and
commercialization of Intermezzo(R) in the United States. For further
information, please visit the company's website at: www.transcept.com.

About Intermezzo(R)
Intermezzo(R) (zolpidem tartrate sublingual tablet), the lead product
candidate at Transcept, has the potential to be the first prescription sleep
aid specifically approved for use in the middle of the night at the time a
patient awakens and has difficulty returning to sleep.  Intermezzo(R) is a
sublingual low dose formulation of zolpidem, the active agent most commonly
prescribed in the United States for the treatment of insomnia.  Intermezzo(R)
uses approximately one-quarter to one-third of the dose of active drug
contained in currently marketed zolpidem-based sleep aids, in a formulation
designed to promote rapid sublingual absorption. Transcept believes that
Intermezzo(R), by combining the reduced zolpidem dose with administration only
on those nights when a middle of the night awakening actually occurs, has the
potential to reduce unnecessary sedative-hypnotic exposure.

Two Phase 3 clinical studies evaluated 376 patients receiving either
Intermezzo(R) or placebo. In the first study, a sleep laboratory trial using
an objective polysomnographic endpoint, Intermezzo(R) demonstrated a
statistically significant decrease versus placebo in the time it took patients
to return to sleep as measured by Latency to Persistent Sleep. In the second
study, an outpatient trial, Intermezzo(R) demonstrated a statistically
significant decrease in Latency to Sleep Onset, a subjective patient reported
endpoint. The most common adverse event seen in these trials was headache (2.7
percent active versus 1.4 percent placebo in the outpatient study). 

The FDA has established October 30, 2009 as its target date under PDUFA to
take action on its review of the NDA.  Transcept is actively pursuing patents
to protect Intermezzo(R) in the United States and key non-U.S. markets, and,
as part of the NDA submission, has requested that the FDA grant three years of
Hatch-Waxman marketing exclusivity to Intermezzo(R). 

Forward Looking Statements
This press release contains forward looking statements for purposes of the
Private Securities Litigation Reform Act of 1995 (the "Act"). Transcept
disclaims any intent or obligation to update these 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 potential for Intermezzo(R) 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 and the potential
for the use of Intermezzo(R) to reduce unnecessary sedative-hypnotic exposure
in the insomnia patient population. 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 FDA determines
that the Intermezzo(R) NDA is sufficient to approve Intermezzo(R) for its
intended indication and any delays in, and the final form of, any FDA approval
of Intermezzo(R); the commercial success of  Intermezzo(R), if approved;
physician or patient reluctance to use Intermezzo(R), if approved; potential
alternative therapies; obtaining and maintaining adequate patent or trade
secret protection without violating the intellectual property rights of
others; obtaining and maintaining Hatch-Waxman exclusivity for Intermezzo(R)
and other difficulties or delays in, clinical development, market acceptance
and commercialization of Intermezzo(R).

    Contacts:

    Transcept Pharmaceuticals, Inc.      The Ruth Group
    Greg Mann                            Investors / Media
    Director of Corporate                Sara Ephraim Pellegrino /
    Communications                       Jason Rando
    (510) 215-3575                       (646) 536-7002 / 7025
    gmann@transcept.com                  spellegrino@theruthgroup.com
                                         jrando@theruthgroup.com





SOURCE  Transcept Pharmaceuticals, Inc.

Greg Mann, Director of Corporate Communications of Transcept Pharmaceuticals,
Inc., +1-510-215-3575, gmann@transcept.com; or Investors, Sara Ephraim
Pellegrino, +1-646-536-7002, spellegrino@theruthgroup.com, or Media, Jason
Rando, +1-646-536-7025, jrando@theruthgroup.com, both of The Ruth Group, for
Transcept Pharmaceuticals, Inc.
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