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MELBOURNE, Australia, March 7 /PRNewswire/ -- Biota Holdings Limited today announced an Agreement with Glaxo Wellcome (NYSE: GLX) which will facilitate and expedite Biota's development and commercialization of a diagnostic for influenza. Biota and Glaxo Wellcome have jointly recognized that optimal use of the influenza therapy, GG167, will be greatly assisted by the availability of a rapid, easy-to-use diagnostic for the physician's office market. The diagnostic is expected to provide rapid confirmation of a physician's diagnosis so that GG167 can be appropriately prescribed when it becomes available for sale. The drug is currently in phase II human clinical trials worldwide and has an anticipated filing date for a product license at the end of 1997.

Under the agreement with Glaxo Wellcome, Biota has exclusive worldwide rights to exploit the intellectual property developed in the GG167 program for the development and marketing of the diagnostic. Subject to regulatory approvals, the diagnostic and GG167 will be made available in the same markets. Glaxo Wellcome will assist Biota with information and test samples from the ongoing clinical trials with GG167 and, subject to availability, will provide certain chemical compounds to Biota.

Biota's diagnostic approach complements GG167 in that it targets the same site on the influenza virus as the drug. Since GG167 is expected to be effective against all medically important strains of influenza virus, Biota's diagnostic is equally expected to bind to and positively detect the same viral strains. Dr. Phillip Reece, Biota's R&D Director, who has directed the project since 1993, said: "Biota's chemists have completed the synthesis of novel compounds with the desired characteristics for the diagnostic and patents have been filed. We believe that our approach is unique in that it incorporates the most desirable feature designed into the therapy, that is, specificity for all medically important strains of influenza virus. This approach may have distinct advantages over antibody approaches which can be affected by strain to strain variability in the virus."

Dr. Hugh Niall, CEO of Biota Holdings, said today: "Biota's work on an influenza diagnostic builds upon years of experience by both companies in targeting the influenza virus. If all goes well our diagnostic will both detect the influenza virus and be predictive of a response to GG167. We have identified several U.S.-based diagnostic companies with the necessary technology and experience in physicians' office diagnostics and are in advanced discussions with our lead candidate to collaborate on this project. We hope soon to move to the next phase and test our reagents in an existing diagnostic device."

Biota's influenza therapy, GG167, is the result of a collaboration between Dr. Peter Colman of the CSIRO and Professor Mark von Itzstein of Monash University, Melbourne. Biota has licensed the development and commercialization of GG167 to Glaxo Wellcome. The activity of GG167 against influenza in an experimental human model was recently published in the January 24/31 issue of the Journal of American Medical Association (Vol. 275; pages 295-299; 1996). GG167 acts by inhibiting the neuraminidase enzyme which is responsible for allowing the spread of the flu virus within the body. Unlike a flu vaccine, which is given to prevent infection, GG167 can be given to people already infected by the virus in order to limit or halt the development of flu symptoms.
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/CONTACT: Hugh D. Niall, M.D., Chief Executive Officer of Biota Holdings Limited, 03-9823-4419; or Corrine Gordon, Corporate Communications Executive of Glaxo Wellcome, 44-181-966-8255/


CO: Biota Holdings Limited; Glaxo Wellcome ST: IN: MTC SU:

TW -- NYTH098 -- 1385 03/07/96 18:22 EST
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Publication:PR Newswire
Date:Mar 7, 1996

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