TorreyPines Therapeutics Strategically Repositions as Development Company Focusing on Three Versatile Lead Compounds
LA JOLLA, Calif., Sept. 25 /PRNewswire/ -- TorreyPines Therapeutics, Inc.(Nasdaq: TPTX) today announced that it will transition from a discovery anddevelopment company to a development-only company, focusing on its threeclinical development programs. As a result, TorreyPines will streamlineoperations through the shut down of its discovery operations, and seek tomonetize non-core assets through the expansion of its business developmentefforts. On September 30, 2008, the company will reduce its work force byapproximately 50 percent, primarily in the area of discovery. As a result ofthis restructuring the company expects to decrease its spending going forward.The company will retain 13 employees supporting preclinical, clinical,business development, and administrative activities.
-- Conduct an end-of-Phase II meeting with the U.S. Food and DrugAdministration (FDA) to discuss the Phase III program for tezampanel in acutemigraine headache. The end-of-Phase II meeting with the FDA is scheduled forSeptember 29th. As reported in October 2007, tezampanel, an AMPA/kainatereceptor antagonist, met its primary endpoint of headache pain relief in adouble-blind, placebo-controlled Phase IIb trial in 306 patients with acutemigraine headache. This trial marked the sixth clinical study demonstratingtezampanel's effectiveness in the treatment of chronic pain.
-- Complete an ongoing Phase I single dose trial to evaluate the analgesiceffect of NGX426, the oral version of tezampanel, in a capsaicin model ofhyperalgesia. This trial will provide data related to the onset, magnitudeand duration of effect of NGX426 and will help guide the direction of theNGX426 Phase II program. In addition, the company will initiate a Phase Imultiple dose trial of NGX426 to provide a platform for conducting chronicdosing clinical trials.
-- Complete an ongoing Phase II trial of NGX267 in xerostomia, or drymouth, secondary to Sjogren's syndrome. The company has demonstrated thesafety of single and multiple doses of NGX267, a muscarinic agonist, in threePhase I trials involving healthy volunteers.
-- Complete the shut down of its discovery operations in connection withthe planned conclusion on September 30, 2008 of the Alzheimer's diseasegenetics collaboration with Eisai Co., Ltd.
TorreyPines will continue to actively seek a development partner for itsclinical compounds: tezampanel, NGX426 and NGX267. In addition, the companywill look to monetize its gamma-secretase modulator (GSM) and Alzheimer'sdisease genetics programs, as well as its compounds: phenserine, Posiphen(TM)and bisnorcymserine.
About TorreyPines Therapeutics
TorreyPines Therapeutics, Inc. is a biopharmaceutical company committed toproviding patients with better alternatives to existing therapies through theresearch, development and commercialization of small molecule compounds. Thecompany's goal is to develop versatile product candidates, each capable oftreating a number of acute and chronic diseases and disorders such asmigraine, chronic pain, muscle spasticity, xerostomia and cognitive disorders.The company is currently developing three product candidates: two ionotropicglutamate receptor antagonists and one muscarinic receptor agonist. Furtherinformation is available at http://www.torreypinestherapeutics.com.
This press release contains forward-looking statements or predictions.Such forward-looking statements include, but are not limited to, statementsregarding the plans for holding an end of Phase II meeting with the FDA, thepotential for tezampanel and NGX426 as treatments for acute migraine and otherindications, the potential for NGX426 to be analgesic, the anticipated timingof results for the NGX426 study in a model of capsaicin-induced pain, theanticipated timing of initiation of a Phase I multiple dose trial of NGX426,the potential for NGX267 as a treatment for xerostomia secondary to Sjogren'ssyndrome, the anticipated timing of results from the study of NGX267 as atreatment for xerostomia secondary to Sjogren's syndrome, the anticipatedtiming of the shut down of discovery operations, the ability to partner any ofthe company's product candidates or programs, and the ability to monetizenon-core assets. Such statements are subject to numerous known and unknownrisks, uncertainties and other factors, which may cause TorreyPines' actualresults to be materially different from historical results or from any resultsexpressed or implied by such forward-looking statements, including whether anypreclinical studies or clinical trials, either ongoing or conducted in thefuture, will prove successful, and if successful, whether the results can bereplicated; whether safety and efficacy profiles of any of the company'sproduct candidates will be established, or if established, will remain thesame, be better or worse in future clinical trials, if any; whetherpre-clinical results will be substantiated by ongoing or future clinicaltrials, if any, or whether any of the company's product candidates will beable to improve the signs or symptoms of their respective clinical indication;whether any of the company's product candidates will support a filing formarketing approval, will be approved by the regulatory authorities, or ifapproved, will prove competitive in the market; or whether the necessaryfinancing to support the company's product development programs will beavailable. In particular there is no guarantee that clinical trials of any ofthe company's product candidates will be completed on schedule or that resultsof these clinical trials will be reported within the anticipated timeframe,that tezampanel or NGX426 will successfully treat migraine and/or otherindications for which they are developed, that the End of Phase II meetingwill be held in the anticipated time frame, that NGX267 will successfullytreat xerostomia secondary to Sjogren's syndrome, that TorreyPines will beable to complete the necessary development work and receive regulatoryapproval for tezampanel, NGX426 or NGX267 or that TorreyPines will be able toreach agreement with a partner for any of the product candidates or programson terms that are acceptable to TorreyPines. These and other risks which maycause results to differ are described in greater detail in the "Risk Factors"section of TorreyPines' annual report on Form 10-K for the year ended December31, 2007 and TorreyPines other SEC reports. The forward-looking statements arebased on current information that is likely to change and speak only as of thedate hereof.
Company Contact: Craig Johnson TorreyPines Therapeutics, Inc. 858-623-5665, x158 cjohnson@torreypinestherapeutics.com Media Contact: David Schull Russo Partners, LLC 212-845-4271 david.schull@russopartners.com Investor Contact: Rhonda Chiger Rx Communications 917-322-2569 rchiger@RxIR.comSOURCE TorreyPines Therapeutics, Inc.
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