Vericiguat Reduced the Risk of Heart Failure
Hospitalization or Cardiovascular Death in Patients with Worsening
Chronic Heart Failure with Reduced Ejection Fraction, Compared to
Placebo When Added to Available Heart Failure Therapies
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today announced that the Phase 3 VICTORIA study evaluating
the efficacy and safety of vericiguat, a soluble guanylate cyclase
(sGC) stimulator being developed to treat patients with worsening
chronic heart failure, has met the primary efficacy endpoint.
Vericiguat reduced the risk of the composite endpoint of heart
failure hospitalization or cardiovascular death in patients with
worsening chronic heart failure with reduced ejection fraction
(HFrEF) compared to placebo when given in combination with
available heart failure therapies. Vericiguat is being jointly
developed with Bayer AG.
“VICTORIA is the first large contemporary outcomes study to
focus exclusively on a population with worsening chronic heart
failure who have a high risk for cardiovascular mortality and
repeated heart failure hospitalizations. We are pleased vericiguat
met this primary endpoint and look forward to sharing the detailed
findings of the study,” said Dr. Roy Baynes, senior vice president
and head of global clinical development, chief medical officer,
Merck Research Laboratories.
“Heart failure affects more than 60 million patients worldwide.
Despite advances in therapies and prevention efforts, the
cardiovascular event rates remain high,” said Dr. Joerg Moeller,
member of the Executive Committee of Bayer AG's Pharmaceutical
Division and head of Research and Development. “There is a high
unmet need for new treatment options to reduce the risk of death
and hospitalizations. We are pleased with the positive outcome with
vericiguat as the first sGC stimulator evaluated in patients with
worsening chronic heart failure with reduced ejection
fraction.”
The results of the VICTORIA study will be presented at an
upcoming medical meeting in 2020.
About the VICTORIA Trial (NCT02861534)
VICTORIA is a randomized, placebo-controlled, parallel-group,
multi-center, double-blind, Phase 3 study of vericiguat versus
placebo when given in combination with available heart failure
therapies in patients with worsening chronic heart failure with
reduced ejection fraction (HFrEF) following a decompensation event,
defined as heart failure hospitalization or receiving an
intravenous diuretic for heart failure without hospitalization. The
primary endpoint of the study is the composite of time to first
occurrence of cardiovascular death or heart failure
hospitalization. Secondary endpoints include time to occurrence of
cardiovascular death, time to first occurrence of heart failure
hospitalization, time to total heart failure hospitalizations
(including first and recurrent events), time to the composite of
all-cause mortality or heart failure hospitalization, and time to
all-cause mortality. The study enrolled 5,050 patients who were
randomized to receive either vericiguat once daily (titrated up to
10 mg) or placebo when given in combination with available heart
failure therapies. The study, which was co-sponsored by Merck and
Bayer, was conducted in collaboration with the Canadian VIGOUR
Centre and the Duke Clinical Research Institute in more than 600
centers in 42 countries.
About Heart Failure With Reduced Ejection Fraction
Heart failure with reduced ejection fraction (HFrEF), formerly
known as systolic heart failure, is characterized by the
compromised ability of the heart to eject blood sufficiently during
its contraction phase. In the U.S., 6.5 million people have heart
failure, and approximately 40-50% of these patients have HFrEF.
Annually, approximately 30% of patients with symptomatic chronic
heart failure will experience worsening of the disease, which is
marked by progressive symptoms and/or a recent heart failure event.
Approximately half of patients with worsening chronic HFrEF are
rehospitalized within 30 days of the worsening event, and an
estimated one in five patients with worsening chronic HFrEF will
die within two years.
About the Worldwide Collaboration Between Bayer and
Merck
Since October 2014, Bayer and Merck (known as MSD outside of the
United States and Canada) 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 Merck.
About Merck
For more than a century, Merck, a leading global
biopharmaceutical company known as MSD outside of the United States
and Canada, has been inventing for life, bringing forward medicines
and vaccines for many of the world’s most challenging diseases.
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 health care
through far-reaching policies, programs and partnerships. Today,
Merck continues to be at the forefront of research to advance the
prevention and treatment of diseases that threaten people and
communities around the world - including cancer, cardio-metabolic
diseases, emerging animal diseases, Alzheimer’s disease and
infectious diseases including HIV and Ebola. For more information,
visit www.merck.com and connect with us on Twitter, Facebook,
Instagram, YouTube and LinkedIn.
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 2018
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).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191118005267/en/
Media: Pamela Eisele (267) 305-3558
Elizabeth Sell (267) 305-3877
Investor: Peter Dannenbaum (908) 740-1037
Michael DeCarbo (908) 740-1807
Merck (NYSE:MRK)
Historical Stock Chart
From Apr 2024 to May 2024
Merck (NYSE:MRK)
Historical Stock Chart
From May 2023 to May 2024