Transcept Pharmaceuticals to Present at Rodman & Renshaw and Baird Healthcare Investor Conferences on September 9 and September
August 26 2009 - 5:05PM
PR Newswire (US)
RICHMOND, Calif., Aug. 26 /PRNewswire-FirstCall/ -- Transcept
Pharmaceuticals, Inc. (NASDAQ:TSPT) today announced that it will
present at two upcoming healthcare investor conferences. -- Rodman
& Renshaw 11th Annual Healthcare Conference on Wednesday,
September 9, 2009, at 10:25 am EDT. -- Baird 2009 Health Care
Conference on Thursday, September 10, 2009, at 10:00 am EDT. A live
audio webcast and replay of the presentations will be available on
the investor webpage at http://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 (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 NDA. Transcept and
Purdue Pharmaceutical Products, L.P. have entered into a
collaboration agreement for the development and commercialization
of Intermezzo in the United States. For further information, please
visit the company's website at: http://www.transcept.com/. About
Intermezzo Intermezzo (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 is a sublingual low dose
formulation of zolpidem, the active agent most commonly prescribed
in the United States for the treatment of insomnia. Intermezzo 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 , 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 or
placebo. In the first study, a sleep laboratory trial using an
objective polysomnographic endpoint, Intermezzo 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 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 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 . 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 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 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 NDA is sufficient to approve
Intermezzo for its intended indication and any delays in, and the
final form of, any FDA approval of Intermezzo ; the commercial
success of Intermezzo , if approved; physician or patient
reluctance to use Intermezzo , 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 and other difficulties or delays in,
clinical development, market acceptance and commercialization of
Intermezzo . DATASOURCE: Transcept Pharmaceuticals, Inc. CONTACT:
Greg Mann, Director of Corporate Communications of Transcept
Pharmaceuticals, Inc., +1-510-215-3575, ; or Investors, Sara
Ephraim Pellegrino, +1-646-536-7002, , or Media, Jason Rando,
+1-646-536-7025, , both of The Ruth Group for Transcept
Pharmaceuticals, Inc. Web Site: http://www.transcept.com/
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