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November 6, 2015 9:31 am ET

Vericiguat study in patients with worsening chronic heart failure and reduced ejection fraction (HFrEF)

Whippany, N.J. and Kenilworth, N.J. – Bayer and Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that new data on vericiguat (BAY 1021189), an investigational oral sGC (soluble guanylate cyclase) stimulator being co-developed by Bayer and Merck for chronic heart failure and reduced left ventricular ejection fraction (HFrEF), will be presented at the upcoming American Heart Association (AHA) Scientific Sessions to be held November 7 to November 11, 2015 in Orlando, Florida. The data were accepted as a late-breaking clinical trial presentation and are the results of the Phase IIb SOCRATES-REDUCED study.  The objective of the study was to investigate the change over 12 weeks in NT-pro BNP (a blood marker of heart failure) to determine the appropriate dose of vericiguat for consideration in a Phase III clinical trial in patients with chronic HFrEF in addition to standard therapy.  

The following data will be presented at AHA Scientific Sessions 2015: 

Vericiguat Data Analysis

• Oral sGC stimulator Vericiguat in patients with worsening chronic heart failure and reduced ejection fraction – The SOluble guanylate Cyclase stimulatoR in heArT failurE patientS with REDUCED EF (SOCRATES-REDUCED) Study
  • Sunday, November 8: 4:13 PM-4:22 PM ET. Session: LBCT.01 – Failure is Not an Option: New Drugs and Systems of Care. Location: Orange County Convention Center, Hall D

“Of the millions who suffer from heart failure, approximately half are estimated to have heart failure with reduced ejection fraction,” said Dr. Daniel Bloomfield, vice president, Cardiovascular Diseases, Merck Research Laboratories. “As a company, we feel it’s important to research additional treatment options for this disease.”

“Heart failure with reduced ejection fraction is an area of unmet need,” said Dario Mirski, MD, vice president of U.S. medical affairs, Bayer Pharmaceuticals. “At Bayer we’re committed to researching and advancing new therapies to help people with this condition.”

Vericiguat is part of a worldwide development collaboration between Merck and Bayer in the field of sGC modulation, which seeks to target a distinct molecular mechanism that is associated with the underlying pathophysiology of heart failure. The soluble guanylate cyclase (sGC) enzyme, which is important for the function of both the blood vessels and the heart, is insufficiently stimulated in heart failure due to impaired NO (nitric oxide) availability and endothelial dysfunction. 

About Worldwide Collaboration between Merck and Bayer

The global collaboration between Merck and Bayer brings together two leaders in the field of sGC research and uses the capabilities and resources of both companies. 

About Heart Failure with Reduced Ejection Fraction (HFrEF)

HFrEF, formerly known as systolic heart failure, is characterized by the compromised ability of the heart to eject blood sufficiently during its contraction phase. HFrEF is a final common pathway for many cardiovascular diseases, including coronary artery disease. Once established, HFrEF often progresses due to activation of a variety of pathways such as the renin-angiotensin-aldosterone system (RAAS) that adversely affect cardiac structure and function. 

About Merck

Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

About Cardiology at Bayer

Bayer is committed to delivering Science For A Better Life by advancing a portfolio of innovative treatments in the areas of cardiovascular, lung and kidney diseases.  The cardiology franchise at Bayer already includes a number of marketed products and several other compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s commitment to research and advancing the science to prioritize targets and pathways with the potential to impact patient outcomes in cardiovascular diseases.  

Bayer: Science For A Better Life

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their lives. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2014, the Group employed around 119,000 people and had sales of EUR 42.2 billion. Capital expenditures amounted to EUR 2.5 billion, R&D expenses to EUR 3.6 billion. These figures include those for the high-tech polymers business, which was floated on the stock market as an independent company named Covestro on October 6, 2015. For more information, go to www.bayer.com.

Forward-Looking Statements of Bayer

This release 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. 

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2014 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

 

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Teri Loxam

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