Merck Submits Applications for Licensure of V114, the Company’s Investigational 15-valent Pneumococcal Conjugate Vaccine, f...
November 23 2020 - 6:47AM
Business Wire
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today announced the company has submitted applications to
the U.S. Food and Drug Administration (FDA) and European Medicines
Agency (EMA) for licensure of V114, Merck’s investigational
15-valent pneumococcal conjugate vaccine, for use in adults 18
years of age and older. The company awaits acceptance of the
submissions by the U.S. and European regulatory authorities.
“For more than a century, Merck inventors have developed
vaccines that help tackle some of society’s biggest public health
challenges, and that heritage is reflected today in our
pneumococcal vaccine portfolio,” said Dr. Roy Baynes, senior vice
president and head of global clinical development, chief medical
officer, Merck Research Laboratories. “These submissions for V114
help bring us closer to offering more options to help protect
against pneumococcal disease.”
The regulatory applications for licensure of V114 include
results from Phase 2 and Phase 3 clinical studies in a variety of
adult populations, including healthy adults and those at increased
risk, such as adults with chronic medical conditions, adults with
HIV, and those 65 years of age and older.
About V114
V114 is Merck’s investigational 15-valent pneumococcal conjugate
vaccine candidate for the prevention of pneumococcal disease in
adults and children. V114 consists of pneumococcal polysaccharides
from 15 serotypes conjugated to a CRM197 carrier protein and
includes serotypes 22F and 33F, which are commonly associated with
invasive pneumococcal disease in older adults worldwide and are not
contained in the pneumococcal conjugate vaccine currently licensed
for use in adults. An overview of the late-stage development
program for V114 is available here.
V114 previously received Breakthrough Therapy Designation from
the FDA for the prevention of invasive pneumococcal disease in
pediatric patients 6 weeks to 18 years of age and adults 18 years
of age and older.
Merck’s Commitment to Infectious Diseases
For more than 100 years, Merck has contributed to the discovery
and development of novel medicines and vaccines to combat
infectious diseases. In addition to a combined portfolio of
vaccines and antibacterial, antiviral and antifungal medicines,
Merck has multiple programs that span discovery through late-stage
development. To learn more about Merck’s infectious diseases
pipeline, visit www.merck.com.
About Merck
For more than 125 years, Merck, 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 in pursuit of our mission to save and improve
lives. We demonstrate our commitment to patients and population
health by increasing access to health care through far-reaching
policies, programs and partnerships. Today, Merck continues to be
at the forefront of research to prevent and treat diseases that
threaten people and animals – including cancer, infectious diseases
such as HIV and Ebola, and emerging animal diseases – as we aspire
to be the premier research-intensive biopharmaceutical company in
the world. 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 the global outbreak of novel coronavirus disease
(COVID-19); 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 2019
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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