Transcept Pharmaceuticals to Present at BMO Capital Markets Healthcare Conference on August 5, 2009
July 22 2009 - 9:00AM
PR Newswire (US)
RICHMOND, Calif., July 22 /PRNewswire-FirstCall/ -- Transcept
Pharmaceuticals, Inc. (NASDAQ:TSPT), a specialty pharmaceutical
company focused on the development and commercialization of
proprietary products that address important therapeutic needs in
the field of neuroscience, announced today that Glenn A. Oclassen,
President & Chief Executive Officer, is scheduled to present at
the BMO Capital Markets Healthcare Conference in New York City on
Wednesday, August 5, 2009 at 4:00 p.m., Eastern Time. An audio
webcast of the presentation will be available at
http://www.transcept.com/. The audio replay of the presentation
will be available at the same location through September 4, 2009.
About Transcept Pharmaceuticals (TSPT) Transcept Pharmaceuticals,
Inc. is a specialty pharmaceutical company focused on the
development and commercialization of proprietary products that
address important therapeutic needs in neuroscience. Its lead
product candidate, Intermezzo (zolpidem tartrate sublingual
tablet), 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. For
further information, please visit the company's website at
http://www.transcept.com/. About Intermezzo Intermezzo (zolpidem
tartrate sublingual tablet), the lead Transcept product candidate,
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. As compared to placebo, two
Phase 3 clinical studies of Intermezzo showed a statistically
significant reduction in the time it took patients to return to
sleep after a middle of the night awakening, and there were no
significant residual effects upon awakening four hours after
dosing. 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. The U.S. Food and
Drug Administration (FDA) has established October 30, 2009 as its
target date under PDUFA (the Prescription Drug User Fee Act) to
take action on its review of the New Drug Application (NDA) for
Intermezzo . 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 . About
Middle of the Night Awakenings Waking up during the night is the
most frequent insomnia symptom reported in the general population.
Based on a recently published epidemiological study of nearly 9,000
individuals, the Stanford Sleep Epidemiology Research Center has
estimated that about one-third of adults in the United States
experience middle of the night awakenings at least three times each
week. The study concluded that more than 90 percent of those
subjects who experienced middle of the night awakenings reported
that this insomnia symptom persisted for at least six months, and
approximately 11 percent had consulted a physician in regard to
this sleep condition. In the Stanford study, fewer than 25 percent
of those experiencing middle of the night awakenings reported
difficulty going to sleep at bedtime. According to IMS Health, the
overall U.S. market for prescription sleep aids was approximately
$4.0 billion in 2008. 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 ability of
Transcept to commercialize Intermezzo effectively, 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 . Contacts: Transcept
Pharmaceuticals, Inc. The Ruth Group Michael Gill Investors / Media
Director of Communications Sara Ephraim Pellegrino / Jason Rando
(510) 215-3575 (646) 536-7002 / 7025 DATASOURCE: Transcept
Pharmaceuticals, Inc. CONTACT: Michael Gill, Director of
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 for Transcept
Pharmaceuticals, Inc. Web Site: http://www.transcept.com/
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