DGAP-Adhoc: Bayer Aktiengesellschaft: Phase III COMPASS study with Bayer"s Rivaroxaban in Patients with Coronary or Peripheral Artery Disease Shows Overwhelming Efficacy and Meets Primary Endpoint Early

2017. február 08., szerda, 16:35





DGAP-Ad-hoc: Bayer Aktiengesellschaft / Key word(s): Research Update/Study results


Bayer Aktiengesellschaft: Phase III COMPASS study with Bayer"s Rivaroxaban in Patients with Coronary or Peripheral Artery Disease Shows Overwhelming Efficacy and Meets Primary Endpoint Early


08-Feb-2017 / 16:35 CET/CEST


Disclosure of an inside information acc. to Article 17 MAR, transmitted by DGAP - a service of EQS Group AG.


The issuer is solely responsible for the content of this announcement.



Leverkusen, February 08, 2017

Bayer AG and its cooperation partner Janssen Research & Development, LLC
today announced that the Phase III trial COMPASS evaluating the efficacy
and safety of rivaroxaban (Xarelto(R)) for the prevention of major adverse
cardiac events (MACE) including cardiovascular death, myocardial infarction
and stroke in patients with coronary artery disease (CAD) or peripheral
artery disease (PAD) has met its primary endpoint ahead of time. Following
a planned interim analysis conducted by the independent Data Monitoring
Committee (DMC), the DMC recommended to stop the trial early as the primary
MACE endpoint has reached its prespecified criteria for superiority. Owing
to the magnitude of effect and the confirmation of the existing safety
profile of rivaroxaban, Bayer, Janssen and the Population Health Research
Institute (PHRI) will offer rivaroxaban to study participants in an
open-label extension trial. The COMPASS study is the largest clinical study
of rivaroxaban to date.

The Phase III COMPASS study was conducted in collaboration with the PHRI
and has enrolled 27,402 patients from more than 600 sites across more than
30 countries worldwide. In the study, patients were randomized to receive
either rivaroxaban 2.5 mg twice daily in addition to aspirin 100 mg once
daily, rivaroxaban 5 mg twice daily alone, or aspirin 100 mg once daily
alone.

A complete data analysis from this study is expected to be presented at an
upcoming medical meeting in 2017.

Forward-Looking Statements

This release may contain forward-looking statements based on current
assumptions and forecasts made by Bayer 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: +49-214-30-33022,
e-mail: peter.dahlhoff@bayer.com, Fax: 0214-30-96-33022




Information and Explanation of the Issuer to this News:



08-Feb-2017 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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Language: English
Company: Bayer Aktiengesellschaft

Kaiser-Wilhelm-Allee 1

51373 Leverkusen

Germany
Phone: +49 (0)214 30-65742
Fax: +49 (0)21430-9665742
E-mail: ir@bayer.com
Internet: www.bayer.com
ISIN: DE000BAY0017
WKN: BAY001
Indices: DAX, EURO STOXX 50, Stoxx 50
Listed: Regulated Market in Berlin, Dusseldorf, Frankfurt (Prime Standard), Hamburg, Hanover, Luxembourg, Munich, Stuttgart; Regulated Unofficial Market in Tradegate Exchange; Madrid





 
End of Announcement DGAP News Service



542939  08-Feb-2017 CET/CEST






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