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FDA ADVISORY PANEL RECOMMENDS APPROVAL FOR MBI'S ALBUNEX(R)

     FDA ADVISORY PANEL RECOMMENDS APPROVAL FOR MBI'S ALBUNEX(R)
    SAN DIEGO, July 15 /PRNewswire/ -- Molecular Biosystems Inc. (NYSE: MB) today announced that yesterday the Radiology Device Advisory Panel of the Food and Drug Administration (FDA) unanimously voted to recommend approval for MBI's Albunex(R) ultrasound contrast agent, stating that Albunex is both safe and effective for the purpose of enhancing two-dimensional echocardiography (ultrasound scans of the heart).  The FDA panel voted on the Pre-Market Approval application for Albunex after a presentation made by MBI's researchers and clinical investigators.
    The company showed Albunex to be effective for enhancing visualization of cardiac anatomy during 2-D echocardiography examinations.  The panel was impressed by the efficacy of the agent in enhancing cardiac border definition and improving clinician's confidence in assessing cardiac wall motion, two important aspects of the overall cardiac diagnostic imaging process.
    Kenneth J. Widder, M.D., MBI's chairman and chief executive officer, stated, "We are extremely pleased with the decision of the FDA panel to recommend the approval of Albunex.  Our extensive development activities, as well as our clinical investigations, have produced compelling data to support our initial product claims.  We are looking forward to our next major Albunex milestones:  the FDA approval letter and the official product launch."
    Not only will Albunex be MBI's first commercial imaging product, but it will also be the first contrast agent approved in the United States for use with diagnostic ultrasound imaging.  Once approved, Albunex will be distributed by Mallinckrodt Medical Inc. (IMCERA Group Inc. (NYSE: IMA)), MBI's marketing partner for North and South America.  Albunex has also been extensively tested in Japan and Europe, and is currently being reviewed by the Japanese Ministry of Health and Welfare for a similar indication.  MBI anticipates that initial European New Drug Applications will be submitted later this year.  In addition, a New Drug submission was recently submitted for approval in Canada by IMCERA's Mallinckrodt Medical unit.
    Molecular Biosystems Inc., based in San Diego, is a leader in the development and manufacturing of contrast agents for medical imaging, including ultrasound, magnetic resonance imaging and computerized tomography.  Once approved, its flagship product, Albunex, will be marketed and distributed worldwide by MBI's partners including Mallinckrodt Medical Inc. (IMCERA Group), Shionogi & Co. Ltd. and Hafslund Nycomed AS.  MBI's shares are listed on the New York Stock Exchange under the symbol "MB."
    -0-                     7/15/92
    /CONTACT:  Richard M. Stern, VP, or Beth Field Wallace of Molecular Biosystems, 619-452-0681, ext. 2212/
    (MB IMA) CO:  Molecular Biosystems Inc.; Mallinckrodt Medical Inc.;
     IMCERA Group Inc. ST:  California IN:  MTC SU: KJ-EH -- SD003 -- 9394 07/15/92 09:02 EDT
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No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1992 Gale, Cengage Learning. All rights reserved.

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Publication:PR Newswire
Date:Jul 15, 1992
Words:435
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