The U.S. Food and Drug Administration Signs on to Renew Access to Iconix's DrugMatrix(R) Database
17 Novembre 2005 - 2:01PM
PR Newswire (US)
Agreement Supports FDA's Goal of Facilitating the Use of
Pharmacogenomic Data in Drug Development 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
(NYSE:SGP), 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 (TSE:MDS)(NYSE:MDZ) and GE Healthcare.
Headquartered in Mountain View, California, Iconix was founded in
1998 and is privately held. For more information, visit
http://www.iconixpharm.com/. Company Contacts: Iconix
Pharmaceuticals Alan Engelberg 650-567-5527 Jennifer Larson
415-946-1074 DATASOURCE: Iconix Pharmaceuticals, Inc. CONTACT: Alan
Engelberg of Iconix Pharmaceuticals, +1-650-567-5527, or ; or
Jennifer Larson of Weisscomm, +1-415-946-1074, or , for Iconix
Pharmaceuticals Web site: http://www.iconixpharm.com/
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