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 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(R) (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 www.transcept.com.
Intermezzo(R) (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(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. As compared to placebo, two Phase 3 clinical studies of Intermezzo(R) 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(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.
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(R). 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).
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(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 ability of Transcept to commercialize Intermezzo(R) effectively, 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 Michael Gill Investors / Media Director of Communications Sara Ephraim Pellegrino / Jason Rando (510) 215-3575 (646) 536-7002 / 7025 firstname.lastname@example.org email@example.com firstname.lastname@example.org
|SOURCE Transcept Pharmaceuticals, Inc.|
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