Bayer submits vericiguat for marketing authorization in China for the treatment of chronic heart failure

Berlin, August 28, 2020 – Bayer today announced the submission of the regulatory application seeking the approval of vericiguat in China. Vericiguat is an investigational oral, once-daily, first-in-class soluble guanylate cyclase (sGC)-stimulator being developed to treat patients with symptomatic chronic heart failure with an ejection fraction less than 45% who have had a previous worsening heart failure event (defined as heart failure hospitalization or receiving an intravenous diuretic for heart failure without hospitalization) in combination with available heart failure therapies. Vericiguat is being jointly developed with MSD (a tradename of Merck & Co., Inc., Kenilworth, NJ, USA).

“Sadly, about 50% of heart failure patients are rehospitalized within 30 days, with each hospitalization doubling the risk of death. Early identification and modification of treatment could reduce these risks,” said Dr. Joerg Moeller, Member of the Executive Committee of Bayer AG's Pharmaceutical Division and Head of Research and Development. “With approximately 13.7 million patients living with heart failure in China, there is an urgent need for new treatment options to help reduce the burden of this disease.”

The New Drug Application was submitted to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) and was based on positive Phase III data from the VICTORIA study. Vericiguat has also been submitted for marketing authorization in the EU and Japan as well as multiple other countries worldwide. In addition, the U.S. FDA has granted priority review to MSD`s New Drug Application (NDA) for vericiguat in July 2020.

About Vericiguat
Vericiguat (BAY 1021189 / MK-1242) is an investigational, oral, once-daily, direct stimulator of the soluble guanylate cyclase (sGC) enzyme. Vericiguat actively restores the functioning of a critical pathway (NO-sGC-cGMP) not addressed by current therapies. While sGC is important for the function of both the blood vessels and the heart, it is insufficiently stimulated in heart failure patients resulting in myocardial and vascular dysfunction. Vericiguat is the first-in-class sGC-stimulator under development in this indication.

About Worldwide Collaboration between Bayer and MSD
Since October 2014, Bayer and MSD (a tradename of Merck & Co., Inc., Kenilworth, NJ, USA) are in a worldwide collaboration in the field of sGC modulators. The collaboration brings together two leading companies that have stated their intent to fully evaluate this therapeutic class in areas of unmet medical need. The vericiguat program is being co-developed by Bayer and MSD.

About Cardiology at Bayer
Bayer is an innovation leader in the area of cardiovascular diseases, with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working in a wide range of therapeutic areas on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs. The cardiology franchise at Bayer already includes a number of products and several other compounds are in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular diseases are treated.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, go to www.bayer.com.

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.

Source: Bayer

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