Gene Logic Welcomes FDA's New Guidance for Pharmacogenomics, Intended

Gene Logic Welcomes FDA's New Guidance for Pharmacogenomics, Intended to Speed Drug Development and Help Foster Personalized Medicine

    Business Editors/Health Editors/Medical Editors
    BIOWIRE2K

    GAITHERSBURG, Md.--(BUSINESS WIRE)--March 25, 2005--

Research Agreement Between Gene Logic and the FDA Aims to Establish Quality Control Standards for Genomic Data Submissions
    Gene Logic Inc. (NASDAQ:GLGC) said today it welcomes the Food and Drug Administration (FDA) Guidance for Industry on Pharmacogenomics Data Submissions. Issued March 22 by the FDA Office of Clinical Pharmacology and Biopharmaceuticals, the guidance is expected to clarify and strengthen the role of pharmacogenomics in new drug discovery and development. The FDA has directed attention to pharmacogenomics, a field of study that examines individual and population responses to therapeutics under preclinical and clinical evaluation, as a new way to improve drug safety and speed development of new medical products. Within pharmacogenomics, Gene Logic has particular expertise in toxicogenomics, an area that assesses the toxic potential of drug candidates using sophisticated predictive and mechanistic capabilities based on gene expression variation.
    FDA and industry experts believe that ultimately pharmacogenomics can be a basis for medicines individualized for efficacy and safety. The FDA intends to ensure that their policies are based on the best science, encompass the many methods of gathering and analyzing pharmacogenomics data, and instill public confidence in the field. A research agreement between the FDA and Gene Logic, begun in August of 2003, aims to help the FDA develop data quality metrics for the toxicogenomics portion of new drug submissions.
    "We believe this new guidance will enhance observatory and predictive drug evaluation systems, alerting drug developers earlier to possible adverse risks of compounds," said Mark Gessler, president and CEO, Gene Logic. "We anticipate that clear guidelines from the FDA will encourage wider use of our pharmacogenomics solutions by pharmaceutical companies. The combined efforts of the FDA and industry will improve drug development and review, offering improved possibilities for a healthier, safer future."
    Gene Logic has one of the world's most comprehensive toxicogenomic databases as well as gene analysis software systems and expertise. The company's reference database is used by pharmaceutical companies to predict compound toxicity in humans. The guidelines released clarify how pharmacogenomics data should be submitted for FDA review prior to approval for marketing as well as how the data will be evaluated.

    Note to Editors:

    Donna Mendrick, Ph.D., vice president, toxicology, for Gene Logic, is a member of the FDA/Drug Information Association (DIA) steering committee, which focuses on integrating pharmacogenomics in clinical trials for new drugs. At the April 11-13 FDA/DIA meeting in Bethesda, Maryland she will co-chair a workshop discussion of international approaches to use of pharmacogenomics for regulatory decision making during clinical development. Dr. Mendrick is available to speak with reporters on behalf of Gene Logic.

    Gene Logic Overview

    Gene Logic aspires to be the most valued biology partner for the pharmaceutical industry. As a leading drug development solutions provider, Gene Logic applies its broad and unique mix of technologies, talent and methodologies to work on behalf of its partners to enable them to make more informed, more reliable and more predictive decisions at each point in the highly complex and costly drug development process. For more information, visit www.genelogic.com or call toll-free - 1/800/GENELOGIC.

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CONTACT: Gene Logic Inc. Investor Contact: Robert G. Burrows, 301-987-1824 Email: rburrows@genelogic.com or Media Contact: Christopher Culotta, 301-987-1752 Email: cculotta@genelogic.com

KEYWORD: MARYLAND INDUSTRY KEYWORD: MEDICAL PHARMACEUTICAL BIOTECHNOLOGY SOFTWARE ALTERNATIVE MEDICINE SOURCE: Gene Logic Inc.

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