- Plan Includes Shut Down of Discovery Operations and Expansion of Business
Development Activities -
LA JOLLA, Calif., Sept. 25 /PRNewswire/ -- TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) today announced that it will transition from a discovery and development company to a development-only company, focusing on its three clinical development programs. As a result, TorreyPines will streamline operations through the shut down of its discovery operations, and seek to monetize non-core assets through the expansion of its business development efforts. On September 30, 2008, the company will reduce its work force by approximately 50 percent, primarily in the area of discovery. As a result of this restructuring the company expects to decrease its spending going forward. The company will retain 13 employees supporting preclinical, clinical, business development, and administrative activities.
TorreyPines' 2008 strategic plan, as presented in February 2008, is intended to maximize the value of the company's clinical stage product candidates: tezampanel, NGX426 and NGX267. By year end 2008 TorreyPines Therapeutics will:
-- Conduct an end-of-Phase II meeting with the U.S. Food and Drug Administration (FDA) to discuss the Phase III program for tezampanel in acute migraine headache. The end-of-Phase II meeting with the FDA is scheduled for September 29th. As reported in October 2007, tezampanel, an AMPA/kainate receptor antagonist, met its primary endpoint of headache pain relief in a double-blind, placebo-controlled Phase IIb trial in 306 patients with acute migraine headache. This trial marked the sixth clinical study demonstrating tezampanel's effectiveness in the treatment of chronic pain.
-- Complete an ongoing Phase I single dose trial to evaluate the analgesic effect of NGX426, the oral version of tezampanel, in a capsaicin model of hyperalgesia. This trial will provide data related to the onset, magnitude and duration of effect of NGX426 and will help guide the direction of the NGX426 Phase II program. In addition, the company will initiate a Phase I multiple dose trial of NGX426 to provide a platform for conducting chronic dosing clinical trials.
-- Complete an ongoing Phase II trial of NGX267 in xerostomia, or dry mouth, secondary to Sjogren's syndrome. The company has demonstrated the safety of single and multiple doses of NGX267, a muscarinic agonist, in three Phase I trials involving healthy volunteers.
-- Complete the shut down of its discovery operations in connection with the planned conclusion on September 30, 2008 of the Alzheimer's disease genetics collaboration with Eisai Co., Ltd.
TorreyPines will continue to actively seek a development partner for its clinical compounds: tezampanel, NGX426 and NGX267. In addition, the company will look to monetize its gamma-secretase modulator (GSM) and Alzheimer's disease genetics programs, as well as its compounds: phenserine, Posiphen(TM) and bisnorcymserine.
About TorreyPines Therapeutics
TorreyPines Therapeutics, Inc. is a biopharmaceutical company committed to providing patients with better alternatives to existing therapies through the research, development and commercialization of small molecule compounds. The company's goal is to develop versatile product candidates, each capable of treating a number of acute and chronic diseases and disorders such as migraine, chronic pain, muscle spasticity, xerostomia and cognitive disorders. The company is currently developing three product candidates: two ionotropic glutamate receptor antagonists and one muscarinic receptor agonist. Further information 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, statements
regarding the plans for holding an end of Phase II meeting with the FDA,
the potential for tezampanel and NGX426 as treatments for acute migraine
and other indications, the potential for NGX426 to be analgesic, the
anticipated timing of results for the NGX426 study in a model of
capsaicin-induced pain, the anticipated timing of initiation of a Phase I
multiple dose trial of NGX426, the potential for NGX267 as a treatment for
xerostomia secondary to Sjogren's syndrome, the anticipated timing of
results from the study of NGX267 as a treatment for xerostomia secondary to
Sjogren's syndrome, the anticipated timing of the shut down of discovery
operations, the ability to partner any of the company's product candidates
or programs, and the ability to monetize non-core assets. Such statements
are subject to numerous known and unknown risks, uncertainties and other
factors, which may cause TorreyPines' actual results to be materially
different from historical results or from any results expressed or implied
by such forward-looking statements, including whether any preclinical
studies or clinical trials, either ongoing or conducted in the future, will
prove successful, and if successful, whether the results can be replicated;
whether safety and efficacy profiles of any of the company's product
candidates will be established, or if established, will remain the same, be
better or worse in future clinical trials, if any; whether pre-clinical
results will be substantiated by ongoing or future clinical trials, if any,
or whether any of the company's product candidates will be able to improve
the signs or symptoms of their respective clinical indication; whether any
of the company's product candidates will support a filing for marketing
approval, will be approved by the regulatory authorities, or if approved,
will prove competitive in the market; or whether the necessary financing to
support the company's product development programs will be available. In
particular there is no guarantee that clinical trials of any of the
company's product candidates will be completed on schedule or that results
of these clinical trials will be reported within the anticipated timeframe,
that tezampanel or NGX426 will successfully treat migraine and/or other
indications for which they are developed, that the End of Phase II meeting
will be held in the anticipated time frame, that NGX267 will successfully
treat xerostomia secondary to Sjogren's syndrome, that TorreyPines will be
able to complete the necessary development work and receive regulatory
approval for tezampanel, NGX426 or NGX267 or that TorreyPines will be able
to reach agreement with a partner for any of the product candidates or
programs on terms that are acceptable to TorreyPines. These and other risks
which may cause 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 December 31, 2007 and TorreyPines other SEC reports. The
forward-looking statements are based on current information that is likely
to change and speak only as of the date hereof.
TorreyPines Therapeutics, Inc.
Russo Partners, LLC
|SOURCE TorreyPines Therapeutics, Inc.|
Copyright©2008 PR Newswire.
All rights reserved