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 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 www.torreypinestherapeutics.com/. |
