deCODE genetics, Inc. (NASDAQ:DCGN)
Industry: Services
deCODE genetics, Inc. (deCODE), incorporated in 1996, is a biopharmaceutical company applying its discoveries in human genetics to develop drugs for common diseases. deCODE has five lead drug discovery and development programs, including three compounds in clinical trials. The most advanced of these programs are in heart attack, peripheral artery disease (PAD) and asthma. deCODE has completed a series of Phase II clinical trials in Iceland for DG031, a compound it licensed from Bayer HealthCare AG for the prevention of heart attack. In 2006, the Company concluded the Phase I clinical program for DG041, its compound for PAD. In asthma, deCODE is conducting a Phase II trial on behalf of the developer of a compound originally designed as a treatment for a different disease. The Company is also applying its findings to create deoxyribonucleic acid (DNA)-based diagnostics. Additionally, deCODE offers its services to fee-paying customers. In January 2006, deCODE acquired all of the outstanding shares of Urdur Verdandi Skuld ehf., a privately held cancer research firm, from Iceland Genomics Corporation, Inc. DG031 In October of 2003, deCODE in-licensed a compound from Bayer AG, renamed DG031, that inhibits leukotriene synthesis through its binding to 5-lipoxygenase activating protein (FLAP). Because of the extensive safety and clinical data already gathered on the compound through previous clinical testing in another indication, in-licensing enabled the Company to advance directly into Phase II clinical testing. During the year ended December 31, 2005, deCODE conducted a series of Phase II clinical trials for DG031. The results demonstrated that DG031 was well tolerated and reduced production of leukotriene B4 (LTB4) in a dose-dependent manner. The Company is designing the Phase III trial under a special protocol assessment with the United States Food and Drug Administration (FDA). The trial deCODE has proposed is a multicenter Phase III study that will focus on African Americans who carry HapK and have a history of heart disease. DG041 DG041 is an inhibitor of the EP3 receptor, and is the first clinical candidate developed entirely through the Company's own capabilities in gene discovery and drug development. It is an orally administered small molecule for the treatment of PAD. In 2005, deCODE submitted an investigational new drug (IND) for DG041 to the FDA, and initiated a Phase I clinical development program. Early results in Phase I trials showed DG041 to be well tolerated and to effectively inhibit platelet aggregation in a dose-dependent manner without increasing bleeding time. Based on its findings in 2005, the Company's chemistry unit developed a formulation that increased the bioavailability of DG041 by nearly four fold. Consequently, deCODE initiated subsequent dose escalation studies on this formulation and concluded the Phase I trials in February 2006. Nearly 200 healthy subjects were exposed to DG041 in these studies at doses up to 1600 milligram/day for seven days. The results of the Phase I program showed DG041 to be well tolerated, without any drug-related significant adverse events noted, and that DG041 can effectively inhibit platelet aggregation in a dose-dependent manner without increasing bleeding time. deCODE expects to begin a Phase II clinical trial in 2006. Third-Party Compound In 2005, deCODE began a Phase II clinical trial in asthma on behalf of the developer of a compound initially developed for another indication. This compound targets a gene previously isolated by deCODE that plays an important role in the inflammatory cascade involved in the development of asthma. The Phase II trial, which is being conducted in Iceland, is a randomized, double-blind and placebo-controlled trial that examines safety and tolerability of the drug, as well as the effectiveness of the drug in improving lung function and reducing airway inflammation at the various dose levels as measured by various clinical tests and biomarkers. Under the terms of the agreement with the developer of the compound, d
As Of: 10/07 00:00 ET
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