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PROSPECTUS SUMMARY DOV PHARMACEUTICAL, INC. OUR COMPANY We are a biopharmaceutical company focused on the discovery, acquisition, development and commercialization of novel drug candidates for central nervous system, cardiovascular and urological disorders. We have five product candidates in clinical trials addressing therapeutic indications with significant unmet needs. Our product candidate for insomnia is currently in Phase III clinical trials and our product candidates for the treatment of anxiety disorders and pain are in Phase II clinical trials. Our product candidates for the treatment of insomnia, anxiety and pain have demonstrated positive results in Phase II clinical trials. Our product candidate for the treatment of angina and hypertension is currently in Phase I clinical trials and we intend to initiate Phase III clinical trials by the end of 2002. Our product candidate for the treatment of depression is currently in Phase I clinical trials. We also have four compounds in preclinical development for the potential treatment of depression, panic disorders, Parkinson's disease, attention deficit disorder and stress incontinence. Our core scientific expertise is in the cellular and molecular pharmacology underlying central nervous system and cardiovascular disorders. Our senior management team has substantial experience in drug discovery and development. During their careers, they have participated in the discovery and development of ten new drugs that have been successfully brought to market. To enhance our drug development and commercialization efforts, we have established collaborative agreements with Elan Corporation, plc and Biovail Laboratories Incorporated, and have sublicensed our product candidate for the treatment of insomnia to Neurocrine Biosciences, Inc. OUR PRODUCT CANDIDATES NBI-34060--INSOMNIA. NBI-34060 is our product candidate for the treatment of insomnia. Neurocrine is currently conducting a Phase III clinical program on NBI-34060 that will involve approximately 3,500 subjects in eight large clinical trials. Neurocrine has completed 19 Phase I and Phase II clinical trials of NBI-34060 for efficacy and safety involving more than 1,100 subjects. In Phase II trials, NBI-34060 has been reported to be more potent than currently marketed sleep promoting treatments and has shown reduced side effects, such as no next day residual sedation, compared to products such as Ambien, currently marketed by Sanofi-Synthelabo. According to IMS Health, Inc., or IMS, U.S. sales of prescription drugs for the treatment of insomnia exceeded $900 million in 2000. We have sublicensed our development and commercialization rights in NBI-34060 to Neurocrine in exchange for the right to receive milestone payments and royalties on net sales, if any. OCINAPLON--ANXIETY. Ocinaplon is our product candidate for the treatment of anxiety disorders, including general anxiety disorder, or GAD. We have completed seven Phase I clinical trials and one Phase II clinical trial on ocinaplon. In the Phase II clinical trial, ocinaplon demonstrated a highly statistically significant reduction of anxiety during the four-week study period using a number of anxiety measurements, with statistically significant effects measured as early as one week, a much shorter period than reported results for current treatments. We are currently conducting a second Phase II clinical trial of ocinaplon, which will involve 200 patients with GAD. We believe ocinaplon addresses significant unmet needs for the treatment of anxiety disorders because our Phase II clinical trial showed it to be at least as effective as what has been reported for currently marketed treatments without their significant side effects, such as sedation, motor incoordination and physical dependence. IMS reports that U.S. sales of anti-anxiety drugs, excluding antidepressants, exceeded $1.4 billion in 2000. We are developing ocinaplon through our joint venture with Elan. 3 <Page> BICIFADINE--PAIN. Bicifadine is our product candidate for the treatment of pain. Bicifadine has been evaluated in four Phase I and 14 Phase II clinical trials involving over 1,000 patients. In five double-blind, placebo-controlled Phase II clinical trials, bicifadine demonstrated a statistically significant reduction of acute pain, in some cases comparable to or better than positive controls such as codeine. In addition, bicifadine has displayed a favorable side effect profile in all clinical trials. We recently began a 750-person Phase II clinical trial of our controlled-release formulation of bicifadine to treat acute dental pain. We also intend to initiate a Phase III clinical trial program by the end of 2002. Depending on the results of these trials, we then intend to file a new drug application with the FDA seeking approval for use of bicifadine to treat pain. We believe bicifadine addresses significant unmet needs for the treatment of pain because it is a non-narcotic that has shown efficacy in clinical trials comparable to currently marketed treatments without the significant side effects of non-narcotic treatments, which include those relating to the gastrointestinal tract and liver, or the addiction and abuse potential associated with narcotics. If ultimately approved, bicifadine would not be limited to use in the pain models studied, but according to FDA guidelines, could be used to treat pain generally. IMS reports that U.S. sales of narcotic and non-narcotic analgesics exceeded $4.6 billion in 2000. We are developing bicifadine through our joint venture with Elan. DOV 216,303--DEPRESSION. DOV 216,303 is our lead product candidate for the treatment of depression. DOV 216,303 affects all three of the neurotransmitters that have been most closely linked to depression. Both preclinical studies and clinical trials indicated that an antidepressant drug affecting the action of all three of these neurotransmitters would be expected to produce a faster onset of action and greater efficacy than antidepressants affecting only one or two of them. No currently marketed antidepressant, including Prozac, affects the action of all three of these neurotransmitters. We recently completed a dose-escalating, double-blind, placebo-controlled Phase I clinical trial aimed at evaluating the blood levels and side effect profile produced by single doses of DOV 216,303. DOV 216,303 was rapidly absorbed following oral administration, with blood levels proportional to the administered dose. No adverse effects were observed after doses five to ten times projected therapeutic doses. We intend to initiate a Phase Ib multiple dose-ranging clinical trial of DOV 216,303 by the end of April 2002. According to IMS, U.S. sales of antidepressants were approximately $9.6 billion in 2000. We have worldwide development and commercialization rights with respect to this product candidate. DOV DILTIAZEM--ANGINA AND HYPERTENSION. DOV diltiazem, our proprietary formulation of diltiazem, is our product candidate for the treatment of angina and hypertension. DOV diltiazem combines an immediate release component with an extended release component in order to reduce morning angina and give better coverage throughout the day than currently marketed diltiazem products. Data from Phase I clinical trials indicated that our formulation produced clinically relevant blood levels within 30 minutes, and resulted in higher blood levels in the morning than Tiazac, a formulation of diltiazem for chronic stable angina, currently marketed by Forest Laboratories in the United States and Biovail Corporation elsewhere in the world. We plan to begin a Phase III clinical trial by the end of 2002 comparing our formulation to placebo and another currently marketed diltiazem formulation. IMS reports that U.S. sales of diltiazem were $981 million in 2000. We are developing DOV diltiazem through our collaboration with Biovail. Biovail will market DOV diltiazem while we have retained worldwide co-promotion rights. | ||||||||||||||
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