We are a biopharmaceutical company focused on the development of novel product candidates for disorders of the central nervous system, or CNS. We currently have drug development programs that are at the preclinical, Phase I and Phase II clinical stages, including DOV 21,947 (in a Phase II clinical trial for depression), DOV 102,677 (which has completed a Phase I clinical trial) and a preclinical discovery program in reuptake inhibitors and GABA modulators. A key element of our business model is the use of strategic collaborations to accelerate development and mitigate risk. We have sublicensing agreements for the development and commercialization of certain product candidates with XTL Biopharmaceuticals, Inc., or XTL, for bicifadine, with Blue Note Pharmaceuticals, Inc., or Blue Note, for DOV diltiazem and with Neurocrine Biosciences, Inc., or Neurocrine, for indiplon.

DOV 21,947, is a triple reuptake inhibitor (serotonin, norepinephrine and dopamine inhibitor), or TRI, with potential efficacy in the treatment of depression and obesity. We recently initiated a Phase II clinical trial of DOV 21,947 which is expected to enroll approximately 200 patients diagnosed with major depressive disorder. The clinical trial is a randomized, double-blind, placebo-controlled, multi-center trial assessing the efficacy and tolerability of DOV 21,947 over a six-week period. We hope to complete the trial as early as the fourth quarter of 2008. In addition, if we are able to secure adequate funding we intend on initiating a Phase II clinical trial with DOV 21,947 in obesity in 2009. DOV 102,677 is another of our TRIs, with potential efficacy in the treatment of alcohol abuse for which the next study will be a Phase I clinical trial administering repeat doses to volunteers and may be initiated in 2009 if adequate funding is available.

Another lead product candidate, bicifadine, has been shown to be effective in treating pain in three placebo-controlled efficacy trials involving more than 1,600 patients with acute post-surgical pain.  XTL has initiated a Phase II clinical trial of bicifadine in patients with diabetic neuropathic pain and has indicated that the results of the trial may be available as early as the fourth quarter of 2008.

DOV diltiazem is our product candidate for the treatment of hypertension and chronic stable angina. Blue Note has advised us that it is conducting a Phase III development program that is expected to culminate in a 505(b)(2) new drug application, or NDA, filing for use in the treatment of hypertension and angina at the end of 2009.

Indiplon is our product candidate for the treatment of insomnia. On December 12, 2007 the FDA restated its view that the indiplon 5mg and 10mg capsules are approvable but set forth additional requirements: (i) an objective/subjective clinical trial in the elderly, (ii) a safety study assessing the rates of adverse events occurring with indiplon when compared to a marketed product, and (iii) a preclinical study to evaluate indiplon administration during the third trimester of pregnancy. Neurocrine intends to meet with the FDA to discuss these requirements. Neurocrine has reported that it has ceased all indiplon clinical development activities in the U.S. as well as all pre-commercialization activities pending its discussions with the FDA.

Our reuptake inhibitor discovery platforms, including TRIs, norepinephrine and dopamine reuptake inhibitors, serotonin and dopamine reuptake inhibitors, and SNRIs (serotonin and norepinephrine reuptake inhibitors) involve compounds that are able to treat a wide variety of neuropsychiatric disorders ranging from depression and attention deficit hyperactivity disorder, to pain and obesity.  We have preclinical molecules belonging to each of these four classes. The primary objective of our GABA modulator discovery program is the development of compounds producing a robust anti-anxiety action without the side effects associated with benzodiazepines such as diazepam, better known as Valium.  At present, only limited activities are being undertaken in relation to the two discovery platforms.