deCODE genetics licenses developmental compound from Bayer AG

Expects to start enrollment for phase II clinical trial in myocardial infarction at the beginning of next year

17-Nov-2003

REYKJAVIK, Iceland - deCODE genetics announced that it has acquired an exclusive worldwide license from Bayer AG to develop and commercialize a small molecule compound. The compound is active against a key target, located within an inflammatory pathway, made by a gene isolated at deCODE that predisposes to myocardial infarction, or heart attack. The compound, DG031, has been shown in previous clinical work in a different indication to be well-tolerated and with no major safety issues. deCODE plans to test it for efficacy in preventing heart attack in an information-rich Phase II clinical trial, enrollment for which is expected to start at the beginning of next year. deCODE plans to provide additional detail on the target and the compound in a scientific article to be submitted at the beginning of the clinical trial. Bayer will receive milestones as the compound advances towards market approval, as well as royalties on sales of the compound as a marketed drug.

"This is a transforming event for deCODE. By licensing an existing compound already found to be well-tolerated, designed against one of our key targets in myocardial infarction, we will be able to leapfrog several stages in the drug development process. We are now in a position to advance by a matter of years the expected timeframe for turning our breakthrough discoveries in the genetics of heart attack into new drugs to combat the biggest killer in the industrialized world," said Kari Stefansson, CEO of deCODE. "Our discovery of genes that confer risk for heart attack gives us a strong advantage when it comes to conducting an efficient and cost-effective clinical trial that can gauge the compound's effectiveness in preventing heart attack in a large and well-defined cohort. The licensing of this compound complements our solid intellectual property portfolio in this area, and we believe represents a major opportunity to capture the value from our research into the genetics of heart attack."

By applying its discovery of genetic risk factors for heart attack, as well as extensive clinical and geneaological data, deCODE has designed a large Phase II clinical trial that provides a significant expected baseline number of cardiovascular events per year. Because the cohort is well characterized both clinically and genetically, the company believes that it can conduct a trial gauging the efficacy of this compound in reducing the number of events in two years. This trial will also enable an analysis of the results in relation to a variety of known risk factors -- such as diabetes, obesity, cholesterol levels, high blood pressure, c-reactive protein and myeloperoxidase -- in addition to the generation of pharmacogenomic data on the impact of genetic and clinical factors on drug response. Dr. Eric Topol, chairman of the department of cardiovascular medicine at the Cleveland Clinic, will participate as a principal advisor in the design and conduct of the planned clinical trial.

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