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: [email protected], 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. Archive at www.dgap.de --------------------------------------------------------------------------- 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: [email protected] 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