09.03.2005 13:03:00

Applied Biosystems and the U.S. Food and Drug Administration Collabora

Applied Biosystems and the U.S. Food and Drug Administration Collaborate to Investigate Diabetes Drug Toxicity


    Business Editors/Health/Medical Writers
    44th Annual Society of Toxicology Meeting
    BIOWIRE2K

    FOSTER CITY, Calif. & NEW ORLEANS--(BUSINESS WIRE)--March 9, 2005--

    Collaborators will use Applied Biosystems Expression Array System
    and Rat Whole Genome Survey Microarray

    Applied Biosystems (NYSE:ABI), an Applera Corporation business, today announced a collaborative research study with the National Center for Toxicological Research of the U.S. Food and Drug Administration (FDA/NCTR) whereby Applied Biosystems will use its Expression Array System and Rat Genome Survey Microarray to investigate the toxicity of a common class of diabetes drugs using samples provided by the FDA/NCTR. Applied Biosystems announced the collaboration in conjunction with the 44th Annual Society of Toxicology Meeting, March 6-10, 2005, at the Ernest Morial Convention Center, New Orleans, LA, U.S.A, where FDA/NCTR and Applied Biosystems will today present early findings from the collaboration during a poster session.
    As part of the collaboration, Applied Biosystems will use its Expression Array System to investigate the molecular basis of liver toxicity associated with certain diabetes drugs.
    In 2000, troglitazone (Rezulin) was withdrawn from the market due to severe liver toxicity with an unknown mechanism. Troglitazone and other currently marketed drugs, such as rosiglitazone (Avandia(R)) and pioglitazone (Actos(R)), are members of a popular class of insulin-sensitizing agents. The mechanism for troglitazone's hepatotoxicity is currently unknown, and it is also unknown whether or not agents in the same chemical class may cause similar gene expression changes that could lead to similar toxicity.
    "Liver toxicity is a leading cause of drug removal from the market," said William V. Murray, Division President of the Molecular Biology Division for Applied Biosystems. "We look forward to helping the FDA determine the reason for toxicity induced by troglitazone, and to identifying similarities or differences in the gene expression profile triggered by this drug and other marketed or investigational drugs in the same class."
    "We are very excited about this collaboration," said Weida Tong, Ph.D., Director of Center for Toxicoinformatics of the FDA/NCTR. "The Rat Genome Survey Microarray and other technologies developed by Applied Biosystems will provide us additional means to understand the molecular basis of the potential liver toxicity associated with the glitazone-based Type II diabetes drug family."
    In addition to its Expression Array System, Applied Biosystems will use its real-time PCR systems and TaqMan(R) Gene Expression Assays to validate the results and extend the study of identified biomarkers to other samples. The FDA/NCTR plans to analyze the data to identify specific genes and pathways associated with liver toxicity and use identified toxicity signatures from the microarray data to predict the toxicity of future drugs in the same chemical class.
    The FDA/NCTR and Applied Biosystems will today present its findings at the Exhibit Hall on Wednesday, March 9, 2005, in Poster Session: Liver II from 1:30-4:30 p.m. CST. The poster number is 1912 and is entitled "Examination of Mechanism(s) of Hepatotoxicity of Anti-diabetic PPARy Agonists Using Rat Primary Hepatocyte Cultures and the Applied Biosystems Rat Whole Genome Survey Microarray."

    About Applera Corporation and Applied Biosystems

    Applera Corporation consists of two operating groups. The Applied Biosystems Group serves the life science industry and research community by developing and marketing instrument-based systems, consumables, software, and services. Customers use these tools to analyze nucleic acids (DNA and RNA), small molecules, and proteins to make scientific discoveries, develop new pharmaceuticals, and conduct standardized testing. Applied Biosystems is headquartered in Foster City, CA, and reported sales of $1.7 billion during fiscal 2004. The Celera Genomics Group (NYSE:CRA) is engaged principally in the discovery and development of targeted therapeutics for cancer, autoimmune and inflammatory diseases. Celera Genomics is leveraging its proteomic, bioinformatic, and genomic capabilities to identify and validate drug targets, and to discover and develop small molecule therapeutics. It is also seeking to advance therapeutic antibody and selected small molecule drug programs in collaboration with global technology and market leaders. Celera Diagnostics, a 50/50 joint venture between Applied Biosystems and Celera Genomics, is focused on discovery, development, and commercialization of diagnostic products. Information about Applera Corporation, including reports and other information filed by the company with the Securities and Exchange Commission, is available at http://www.applera.com, or by telephoning 800.762.6923. Information about Applied Biosystems is available at http://www.appliedbiosystems.com/.

    Certain statements in this press release are forward-looking. These may be identified by the use of forward-looking words or phrases such as "believe," "expect," "plans," and "should" among others. These forward-looking statements are based on Applera Corporation's current expectations. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for such forward-looking statements. In order to comply with the terms of the safe harbor, Applera Corporation notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. These factors include but are not limited to (1) rapidly changing technology and dependence on the development of new products; (2) Applied Biosystems' dependence on the operation of computer hardware, software, and Internet applications and related technology; (3) unproven use of genomics information to develop or commercialize products; (4) market adoption of the technology; (5) claims for patent infringement; and (6) other factors that might be described from time to time in Applera Corporation's filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Applera does not undertake any duty to update this information, including any forward-looking statements, unless required by law.

    For Research Use Only. Not for use in diagnostic procedures.

    Copyright(C) 2005. Applera Corporation. All rights reserved. Applied Biosystems and Celera are registered trademarks and Applera, Celera Diagnostics, Celera Genomics, Celera Discovery System, and Panther are trademarks of Applera Corporation or its subsidiaries in the U.S. and/or certain other countries.

    TaqMan is a registered trademark of Roche Molecular Systems, Inc.

    All other trademarks are the property of their respective owners.

--30--CRD/sf*

CONTACT: Applied Biosystems Lori Murray, 650-638-6130 (Media) murrayla@appliedbiosystems.com Linda Greub, 650-554-2349 (Investors) greublm@appliedbiosystems.com or Applied Biosystems (European Media and Investors) David Speechly, Ph.D., (+) 44.162.273.9150 speechdp@eur.appliedbiosystems.com or FDA/NCTR Weida Tong, Ph.D., 870-543-7142 wtong@nctr.fda.gov

KEYWORD: LOUISIANA CALIFORNIA TRACK INDUSTRY KEYWORD: MEDICAL DEVICES PHARMACEUTICAL MEDICAL BIOTECHNOLOGY TRADESHOW PRODUCT MARKETING AGREEMENTS SOURCE: Applied Biosystems

Copyright Business Wire 2005

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