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MOUNTAIN VIEW, Calif.—A pilot service agreement between Iconix Pharmaceuticals and Merck KGaA is drawing on Iconix's toxicogenomics tech­nology to perform in vitro stud­ies of Merck compounds.
 
Phil Hewitt, head of toxicoge­nomics for Merck KGaA, says Merck provided Iconix with five compounds—three mol­ecules that were halted in vari­ous stages of development and two references—to gain insight into the value of Iconix's in vitro work and better understand the compounds. Merck, says Hewitt, could establish a long-term collaboration with Iconix. "This is a first pilot project, and I really hope that this is the first step toward a continuing rela­tionship with this company and that it will be routine. The aim would be to have them part of Merck's future in terms of ana­lyzing gene expression data."
 
Jim Neal, CEO at Iconix, sees the agreement as validation of Iconix's in vitro toxicogenomics platform, which, by leveraging in vivo rat liver cell data that show gene expression changes result­ing from drug exposure, looks for patterns predictive of various toxicology outcomes. "We will provide [Merck] with a report that identifies the assets and lia­bilities of the compounds through the lens of this rat hepatocyte gene expression profile," says Neal.
 
Neal believes Iconix's program, which has been available commer­cially for six months, is unique in the industry. "The reason we can do this in vitro is because of what we've done in vivo. We have pro­filed over 350 compounds in rat liver, so what we're developing is a cell-based system to predict and mirror [in vitro] what's going on in the in vivo system." Iconix's in vitro data include information on 119 compounds used with rat hepa­tocytes and build on the compa­ny's in vivo database, DrugMatrix, which profiles more than 600 drugs, toxicants, and standards, and is used at the FDA.
 
The new project, which began in August and should be completed this fall, provides Merck an oppor­tunity to test the collaboration itself and determine the value of Iconix's global expression infor­mation in making decisions about early removal of potentially toxic drug candidates, says Hewitt. Although Merck might also con­tract for a developmental proj­ect with Iconix competitor Gene Logic, Hewitt notes by comparison that "the databases are slightly dif­ferent and there [are] more com­pounds in Iconix's."
 
No financial details of the deal were released, but Hewitt says "we have a special deal with Iconix as a one-off," partly becasue some Merck data may enter the Iconix database. Hewitt stresses that toxi­cogenomics is not new to Merck, though he says in-house in vitro profiling sometimes gets stuck when the company lacks back­ground like that in Iconix's data­base. Merck contracts work to the Fraunhofer Institute in Hannover, Germany, and students also per­form research, so Hewitt sees them benefiting from Iconix's data on "dead" molecules in an interest­ing target area that could poten­tially see more development in the future.
 
Iconix hopes that, as toxicoge­nomics continues to gain valida­tion and acceptance, its use will expand in drug discovery. Neal is optimistic that toxicogenom­ics will eventually become part of standard operating procedures for early lead optimization. "We think there's a lot more molecules that could be candidates," he says.

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