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On September 30, 2008, Transcept submitted a New Drug Application forIntermezzo(R) to the U.S. Food and Drug Administration. On August 29, 2008,Transcept and Novacea, Inc. (Nasdaq: NOVC) entered into a definitive mergeragreement under which, if completed, Novacea will merge with Transcept.Assuming a close near the end of 2008, the combined company is expected tohave an estimated cash balance of $88 to $92 million.
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Thomas Roth, Ph.D., Director of Research, Chief of Sleep Medicine for theHenry Ford Hospital Sleep Disorders and Research Center, was the principalauthor and investigator for the randomized, double-blind, placebo-controlled,3-way cross-over study of the safety and efficacy of Intermezzo(R) at doses of1.75 mg and 3.5 mg compared to placebo. The study evaluated 82 adults at fivesleep laboratories with a diagnosis of DSM-IV primary insomnia and a historyof prolonged middle of the night awakenings. Subjects were randomized toreceive 1.75 mg or 3.5 mg doses of Intermezzo(R), or a placebo, over three2-night treatment periods.
The study results demonstrated that Intermezzo(R) 1.75 mg and 3.5 mgdoses, when taken at the time of a middle of the night awakening,significantly shortened the time for patients to return to sleep as comparedto placebo and there was no evidence of next morning residual effects.Patients taking Intermezzo(R) 3.5 mg also had statistically significantimprovements in post-dose total sleep time, sleep efficiency, subjectivenumber of awakenings and sleep quality. Morning questionnaires also revealedimprovements in the level of refreshed sleep and next day ability to functioncompared to placebo.
Dr. Roth commented, "This study supports the safety and efficacy ofIntermezzo(R) for the treatment of middle of the night awakenings at the timethey occur. The most commonly prescribed sleep medications are intended to betaken at bedtime and they produce sleep for seven to eight hours after dosing.Such medications can be used at bedtime to prevent an awakening later in thenight, but the patient must either anticipate which nights an awakening mayoccur, or take a seven to eight hour sleep aid every night. The results ofthis study suggest that low dose sublingual zolpidem (Intermezzo(R)) may offerpatients a fast acting low-dose alternative that can be taken only when it isreally needed at the time of an awakening, and which provides rapid return tosleep without the risk of residual sedation the following morning."
Glenn A. Oclassen, President and Chief Executive Officer of Transcept,remarked, "We congratulate Dr. Roth and his colleagues on the publication inSLEEP. Along with our Phase 3 outpatient study, Dr. Roth's sleep-lab studyserves as the foundation for the Intermezzo(R) New Drug Application werecently submitted to the U.S. Food and Drug Administration."
About the Proposed Transcept and Novacea Merger
On August 29, 2008, Transcept Pharmaceuticals, Inc. and Novacea, Inc.(Nasdaq: NOVC) entered into a definitive merger agreement under which Novaceawill merge with Transcept in an all-stock transaction. Assuming a close nearthe end of 2008, the combined company is expected to have an estimated cashbalance of $88 to $92 million. Further information on the merger agreement isavailable in the last section of this press release, entitled "AdditionalInformation about the Merger and Where to Find It."
About SLEEP
SLEEP is the official publication of the Associated Professional SleepSocieties, LLC (APSS) a joint venture of the American Academy of SleepMedicine and the Sleep Research Society. A reprint of the study can be viewedonline at http://www.journalsleep.org/ViewAbstract.aspx?citationid=3662.
About Transcept Pharmaceuticals
Transcept Pharmaceuticals is a specialty pharmaceutical company focused onthe development and commercialization of proprietary products that addressimportant therapeutic needs in the fields of psychiatry and sleep medicine.The lead Transcept product candidate, Intermezzo(R), is a sublingual low doseformulation of zolpidem that has been developed for use as-needed for thetreatment of insomnia when a middle of the night awakening is followed bydifficulty returning to sleep. Intermezzo(R) Phase 3 clinical trials have beencompleted and, on September 30, 2008, Transcept submitted a New DrugApplication for Intermezzo(R) to the U.S. Food and Drug Administration.
For further information, please visit the company's website at:http://www.transcept.com.
About Novacea
Novacea, Inc. is a biopharmaceutical company that had been focused onin-licensing, developing and commercializing novel cancer therapies. Novaceahas two product candidates, including Asentar(TM), which had been in a Phase 3clinical trial for androgen-independent prostate cancer, and AQ4N, ahypoxia-activated prodrug. There are currently no clinical trials planned orunderway for either candidate.
Safe Harbor
This press release contains forward-looking statements for purposes of thePrivate Securities Litigation Reform Act of 1995 (the "Act"). Transcept andNovacea disclaim any intent or obligation to update these forward-lookingstatements, and claim the protection of the Safe Harbor for forward-lookingstatements contained in the Act. Examples of such statements include, but arenot limited to, the expected timing of closing the merger; the expected cashbalance of the combined entity as of the closing; and the expected benefits ofTranscept product candidates. Such statements are based on management'scurrent expectations, but actual results may differ materially due to variousrisks and uncertainties, including, but not limited to, failure of Novaceastockholders to approve the merger; Novacea or Transcept inability to satisfythe conditions of the merger, or that the merger is otherwise delayed orultimately not consummated; the rates of use of Transcept and Novacea cash andcash equivalents prior to the closing of the merger; positive results inclinical trials may not be sufficient to obtain FDA approval; physician orpatient reluctance to use Intermezzo(R), if approved; potential alternativetherapies; maintaining adequate patent or trade secret protection withoutviolating the intellectual property rights of others; and other difficultiesor delays in, obtaining regulatory approval, market acceptance andcommercialization of Intermezzo(R).
Additional Information about the Merger and Where to Find It
This communication may be deemed to be solicitation material in respect ofthe proposed transaction between Transcept and Novacea. On October 3, 2008,Novacea filed a joint proxy statement/prospectus/information statement inconnection with the merger with Transcept. Once declared effective by the SEC,the final proxy statement included in the Form S-4 will be mailed to Novaceastockholders prior to a meeting of Novacea stockholders to consider the mergerproposal. Investors and security holders of Novacea and Transcept are urged toread the proxy statement/prospectus/information statement because it willcontain important information about Novacea, Transcept and the proposedtransaction. The proxy statement/prospectus/information statement, and anyother documents filed by Novacea with the SEC, may be obtained free of chargeat the SEC web site at http://www.sec.gov. In addition, investors and securityholders may obtain free copies of the documents filed with the SEC by Novaceaby contacting Novacea Investor Relations by e-mail at [email protected] or bytelephone at (650) 228-1800. Investors and security holders are urged to readthe proxy statement/prospectus/information statement and the other relevantmaterials before making any voting or investment decision with respect to theproposed transaction.
Novacea and its respective directors and executive officers may be deemedto be participants in the solicitation of proxies from its stockholders infavor of the proposed transaction. Information about the directors andexecutive officers of Novacea and their respective interests in the proposedtransaction is available in the proxy statement/prospectus/informationstatement.
Intermezzo(R) and Bimucoral(R) are registered trademarks of TransceptPharmaceuticals, Inc.Contacts: Transcept Pharmaceuticals, Inc. Michael Gill Director of Communications (510) 215-3575 [email protected] The Ruth Group (on behalf of Transcept) Investors Stephanie Carrington / Sara Ephraim (646) 536-7017 / 7002 [email protected] [email protected] Media Jason Rando (646) 536-7025 [email protected]
SOURCE Transcept Pharmaceuticals, Inc.
