DJ DGAP-Adhoc: Bayer Aktiengesellschaft: FDA has published documents for discussion at the Advisory Committee on the new drug application for Rivaroxaban

DJ DGAP-Adhoc: 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 
ISIN:         DE000BAY0017 
WKN:          BAY001 
Indices:      DAX, EURO STOXX 50, Stoxx 50 
Listed:       Regulierter Markt in Berlin, Düsseldorf, Frankfurt (Prime 
              Standard), Hamburg, Hannover, München, Stuttgart; Terminbörse 
              EUREX; London, Madrid, SIX 
 
End of Announcement                             DGAP News-Service 
 
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(END) Dow Jones Newswires

September 06, 2011 09:20 ET (13:20 GMT)