Bayer Aktiengesellschaft: FDA has published documents for discussion at the Advisory Committee on the new drug application for Rivaroxaban
Bayer Aktiengesellschaft  / Key word(s): Regulatory Admission

06.09.2011 15:20

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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Leverkusen, Germany, September 6, 2011. The U.S. Food and Drug
Administration (FDA) have published on its website certain documents which
will be the subject of an advisory committee (AdCom) meeting scheduled for
September 8, 2011. The briefing document reflects the views of the
individual FDA reviewers prior to the AdCom meeting and not necessarily the
position of the Agency. The AdCom will discuss the new drug application for
Rivaroxaban for the prevention of stroke and systemic embolism in patients
with non-valvular atrial fibrillation against the background of the Rocket
AF study.  Johnson & Johnson's (Bayer's cooperation partner)
representatives will be presenting at the AdCom in addition to
representatives of the FDA.
The FDA will issue a final determination taking into account the input by
the AdCom.  Such decision is expected for early November 2011. The
documents are available on the internet at
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm261963.htm.


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Information and Explaination of the Issuer to this News:

Forward-Looking Statements 
This Ad-hoc Statement may contain 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.


Contact:
Mr.Peter Dahlhoff, Bayer AG, Investor Relations, Phone: 0214-30-33022,
e-mail: peter.dahlhoff@bayer.com, Fax: 0214-30-96-33022



06.09.2011 DGAP's Distribution Services include Regulatory Announcements, 
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de

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Language:     English
Company:      Bayer Aktiengesellschaft
              Kaiser-Wilhelm-Allee 1
              51373 Leverkusen
              Germany
Phone:        +49 (0)21430-1
Fax:          +49 (0)21430-66328
E-mail:       alexander.rosar.ar1@bayer-ag.de
Internet:     www.bayer-ag.de
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              EUREX; London, Madrid, SIX
 
End of Announcement                             DGAP News-Service
 
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