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The U.S. FDA Signs On To Renew Access To Iconix Pharmaceuticals, Inc.'s DrugMatrix(R) Database


11/17/2005 11:13:49 AM

MOUNTAIN VIEW, Calif., Nov. 17 /PRNewswire/ -- Today, Iconix Pharmaceuticals, Inc. announced the renewal of its agreement with the U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), to provide CDER with research access to its DrugMatrix(R) system. The system is the largest private and public reference set of data on the genomic effects of drugs, biochemicals and toxicants. DrugMatrix was originally installed at the FDA in March 2003 and for the past three years, Iconix and the company's DrugMatrix have provided CDER with hands-on experience using chemogenomic data and tools, including the application of genomic markers, to profile the effects of drugs.

In the renewed use agreement, Iconix is providing access to DrugMatrix to the FDA's new cross-center Interdisciplinary Pharmacogenomic Review Group (IPRG), established in March as part of the Agency's move toward incorporating chemogenomic data into the drug approvals process. The role of the IPRG is to review Voluntary Genomic Data Submissions (VGDSs) and advise the FDA on interpretation and evaluation of pharmacogenomic data. VGDSs are pharmacogenomic data voluntarily submitted to the Agency when such data are not required under the regulations. DrugMatrix provides an important tool for the FDA's use in evaluating genomic data submitted under the new "Pharmacogenomics Data Submission" guidelines. In the past six months both pharmaceutical companies and the FDA have used Iconix's DrugMatrix to analyze VGDS's submitted to the FDA.

"We are pleased that the FDA chose to renew its access to DrugMatrix and that it is playing a key role in helping the Agency evaluate the uses of new genomic data and genomic biomarkers," said Jim Neal, CEO, Iconix. "We have enjoyed working with CDER and continue to view the relationship as a positive opportunity to demonstrate how the private and public research communities can work together to ultimately make the drug discovery, drug development, and drug review process more effective and efficient." In March 2005, the FDA issued the final version of its guidance, "Pharmacogenomic Data Submissions" to provide pharmaceutical companies with guidelines on the use of pharmacogenomic and toxicogenomic data. In the Guidance, the Agency sought to address the reluctance of pharmaceutical companies to use pharmacogenomic information because of uncertainties in how the data will be used by FDA in the drug application review process. The number of voluntary genomic data submissions has increased steadily since the publication of the guidelines.

About Iconix:

Iconix Pharmaceuticals, Inc. is pioneering the new field of chemogenomics, the integration of chemistry and genomics to profile drug candidates. Iconix's chemogenomic capabilities enable pharmaceutical companies to increase the odds of advancing the right compounds to the clinic, reducing attrition rates and the costs of drug discovery. Iconix provides reference systems and know-how to predict toxic liabilities, side effects and mechanisms of drug candidates. The company has collaborations with Bristol Myers Squibb, Abbott Laboratories, ICOS, Schering-Plough , AstraZeneca, Taisho Pharmaceutical Co., Ltd., Eisai Co., Ltd. and other leading companies. Iconix also provides research, training and support to the U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER) under an agreement to advance CDER's study of the application of genomic technologies in the regulatory approval process. Iconix's DrugMatrix system has been installed at the FDA for use by CDER scientists and reviewers in a diverse range of chemogenomics applications. Iconix also has a contract to profile compounds for the Environmental Protection Agency. The company has strategic partnerships with leading life sciences companies including MDS Pharma Services and GE Healthcare.

Headquartered in Mountain View, California, Iconix was founded in 1998 and is privately held. For more information, visit www.iconixpharm.com.

Company Contacts: Iconix Pharmaceuticals Alan Engelberg 650-567-5527 aengelberg@iconixpharm.com Jennifer Larson 415-946-1074 jlarson@weisscommpartners.com

Iconix Pharmaceuticals, Inc.

CONTACT: Alan Engelberg of Iconix Pharmaceuticals, +1-650-567-5527, oraengelberg@iconixpharm.com; or Jennifer Larson of Weisscomm,+1-415-946-1074, or jlarson@weisscommpartners.com, for IconixPharmaceuticals


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