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    DGAP-Adhoc  1003  0 Kommentare Bayer Aktiengesellschaft: Phase III ROCKET AF Study of Rivaroxaban meets its primary efficacy endpoint with Comparable Safety vs. Warfarin



    Bayer Aktiengesellschaft  / Key word(s): Research Update

    31.10.2010 20:50

    Dissemination of an Ad hoc announcement according to § 15 WpHG, transmitted
    by DGAP - a company of EquityStory AG.
    The issuer is solely responsible for the content of this announcement.




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    Bayer Aktiengesellschaft: Phase III ROCKET AF Study of Rivaroxaban meets
    its primary efficacy endpoint with Comparable Safety vs. Warfarin

    Leverkusen, Germany, October 31, 2010

    Bayer today announced the preliminary results of the pivotal Phase III
    ROCKET AF study of rivaroxaban, the full details of which will be presented
    at the Late Breaker Session on November 15, 2010, [10:45 am - 10:55 am
    CST], at the Scientific Sessions of the American Heart Association (AHA) in
    Chicago, USA.

    The primary objective of the study was to establish the non-inferiority of
    20 mg rivaroxaban once-daily (or 15 mg in patients with moderate renal
    impairment at screening) compared to dose-adjusted warfarin in patients
    with non-valvular atrial fibrillation (AF) at risk of stroke and non-CNS
    systemic embolism. The primary efficacy endpoint was a composite of
    all-cause stroke and non-CNS systemic embolism. The primary safety endpoint
    was the composite of major and non-major clinically relevant bleeding
    events.

    Rivaroxaban has met its primary efficacy endpoint versus dose-adjusted
    warfarin. The rates of the composite of major and non-major clinically
    relevant bleeding were comparable.

    ROCKET AF (Rivaroxaban Once daily oral direct Factor Xa inhibition Compared
    with vitamin K antagonism for prevention of stroke and Embolism Trial in
    Atrial Fibrillation) was an event-driven, prospective, randomized,
    double-blind Phase III study in which more than 14,000 patients have been
    enrolled from more than 1,100 centers across 45 countries worldwide. The
    study was led by the Duke Clinical Research Institute, Durham, North
    Carolina, USA, and an international academic executive committee.




    Information and Explaination of the Issuer to this News:

    Forward-Looking Statements:
    This Ad-hoc Statement contains forward-looking statements based on current
    assumptions and forecasts made by Bayer Group or subgroup management.
    Various known and unknown risks, uncertainties and other factors could lead
    to material differences between the actual future results, financial
    situation, development or performance of the company and the estimates
    given here. These factors include those discussed in Bayer´s public
    reports, which are available on the Bayer website at www.bayer.com. The
    company assumes no liability whatsoever to update these forward-looking
    statements or to conform them to future events or developments.

    31.10.2010 20:50 DGAP´s Distribution Services include Regulatory Announcements,
    Financial/Corporate News and Press Releases.
    Media archive at www.dgap-medientreff.de and www.dgap.de




    Language:     English
    Company:      Bayer Aktiengesellschaft
                  Kaiser-Wilhelm-Allee 1
                  51373 Leverkusen
                  Deutschland
    Phone:        +49 (0)21430-1
    Fax:          +49 (0)21430-66328
    E-mail:       alexander.rosar.ar1@bayer-ag.de
    Internet:     www.bayer-ag.de
    ISIN:         DE000BAY0017
    WKN:          BAY001
    Indices:      DAX, EURO STOXX 50, Stoxx 50
    Listed:       Regulierter Markt in Frankfurt (Prime Standard), Berlin,
                  Stuttgart, Hannover, Hamburg, München, Düsseldorf;
                  Terminbörse EUREX; Foreign Exchange(s) London, Madrid, SIX

    End of Announcement                             DGAP News-Service






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    DGAP-Adhoc Bayer Aktiengesellschaft: Phase III ROCKET AF Study of Rivaroxaban meets its primary efficacy endpoint with Comparable Safety vs. Warfarin Bayer Aktiengesellschaft  / Key word(s): Research Update31.10.2010 20:50 Dissemination of an Ad hoc announcement according to § 15 WpHG, transmittedby DGAP - a company of EquityStory AG.The issuer is solely responsible for the content of this …

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