In PNEU-PATH (V114-016) and PNEU-DAY
(V114-017), V114 Met Primary Immunogenicity Objectives and Elicited
A Strong Immune Response for All 15 Serotypes Included in the
Vaccine, Including 22F and 33F - Serotypes Unique to V114
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today announced findings from two additional Phase 3
studies evaluating the safety, tolerability and immunogenicity of
V114, the company’s investigational 15-valent pneumococcal
conjugate vaccine. In the PNEU-PATH (V114-016) study, healthy
adults 50 years of age or older received V114 or PCV13 followed by
PNEUMOVAX® 23 one year later. Immune responses following
vaccination with PNEUMOVAX 23 (month 13) were comparable in both
vaccination groups for the 15 serotypes in V114. Results also
showed that at 30 days post vaccination with either V114 or PCV13
(day 30), immune responses were comparable for both groups across
the 13 serotypes shared by the conjugate vaccines and higher in the
V114 group for serotypes 22F and 33F, the two serotypes not
included in PCV13. In PNEU-DAY (V114-017), a Phase 3 study in
immunocompetent adults 18 to 49 years of age with underlying
medical conditions associated with increased risk for pneumococcal
disease, V114 generated immune responses generally comparable to
PCV13 for the 13 shared serotypes and higher immune responses for
serotypes 22F and 33F at 30 days post-vaccination. Results from
both studies are based on opsonophagocytic activity (OPA) responses
– a measure of vaccine-induced functional antibodies. V114 was
generally well tolerated in both studies, with a safety profile
consistent with that observed for V114 in previously reported
studies.
“Pneumococcal disease in adults is on the rise globally, in part
driven by disease-causing serotypes not targeted by the currently
available pneumococcal conjugate vaccine,” said Dr. Roy Baynes,
senior vice president and head of global clinical development,
chief medical officer, Merck Research Laboratories. “These data
provide important information about the potential for V114 followed
by PNEUMOVAX 23, a polysaccharide vaccine included in more than 90
percent of age-based adult pneumococcal immunization programs
globally, to help protect healthy adults and adults who are at
increased risk for pneumococcal disease.”
Findings from the V114 Phase 3 clinical program in adults,
including PNEU-PATH and PNEU-DAY, will be presented at a future
scientific congress. Plans for global regulatory licensure
applications, beginning with the U.S. Food and Drug Administration
before the end of the year, remain on track.
There are more than 90 different types of pneumococcal bacteria
which can affect adults differently than children. Pneumococcal
serotypes not in the currently licensed conjugate vaccine, such as
22F and 33F, are among the most common serotypes causing invasive
pneumococcal disease in parts of the world, including the U.S.,
among adults 65 years of age or older. Invasive pneumococcal
disease due to serotypes 22F and 33F has been linked to higher case
fatality rates and prolonged hospitalization in adults. Overall,
adults with certain medical conditions, such as heart disease,
diabetes or chronic obstructive pulmonary disease (COPD), have a
higher risk for pneumococcal disease compared to those without
these conditions.
The V114 Phase 3 clinical development program is comprised of 16
trials investigating the safety, tolerability and immunogenicity of
V114 in a variety of populations who are at increased risk for
pneumococcal disease, including healthy older adults and children,
as well as people who are immunocompromised or have certain chronic
medical conditions. An overview of the late-stage development
program is available here.
About PNEU-PATH
PNEU-PATH is a Phase 3, multi-center, randomized, double-blind,
active comparator-controlled study evaluating the safety,
tolerability and immunogenicity of V114 followed by administration
of PNEUMOVAX 23 one year later in healthy adults 50 years of age or
older (n=652). The primary endpoints included serotype specific OPA
geometric mean titers (GMTs) at 30 days post-vaccination with
PNEUMOVAX 23. The serotype specific OPA GMTs at 30 days
post-vaccination with PNEUMOVAX 23 were comparable in the V114 and
PCV13 groups for all 15 serotypes in V114.
Secondary endpoints included serotype specific OPA GMTs at 30
days post-vaccination with either V114 or PCV13. The OPA GMTs were
comparable for the 13 shared serotypes between V114 and PCV13 at 30
days post-vaccination with either V114 or PCV13. The OPA GMTs were
higher in the V114 group compared with the PCV13 group for the two
serotypes unique to V114 (22F and 33F) at 30 days post-vaccination
with either V114 or PCV13. Results of the safety analyses
demonstrated that V114 was generally well tolerated and can be
followed by PNEUMOVAX 23.
About PNEU-DAY
PNEU-DAY is a Phase 3, multi-center, randomized, double-blind,
active comparator-controlled study evaluating the safety,
tolerability and immunogenicity of V114 followed by administration
of PNEUMOVAX 23 six months later in adults between 18 and 49 years
of age who are at increased risk for pneumococcal disease due to an
underlying medical condition, behavioral habits, or living in an
environment with increased risk of disease transmission (n=1,514).
Participants were considered at increased risk for pneumococcal
disease due to the presence of one or more risk factors, including
chronic lung disease, smoking, diabetes mellitus, chronic liver
disease, chronic heart disease and alcohol consumption.
The primary endpoints included serotype specific OPA GMTs at 30
days post-vaccination with either V114 or PCV13. The OPA GMTs were
generally comparable for the 13 shared serotypes between V114 and
PCV13 at 30 days post-vaccination. The OPA GMTs were higher in the
V114 group compared with the PCV13 group for the two serotypes
unique to V114 (22F and 33F) at 30 days post-vaccination.
Results of the safety analyses demonstrated that V114 was
generally well tolerated with a safety profile generally comparable
to PCV13 and consistent with that observed in previously reported
studies.
About V114
V114 is Merck’s investigational 15-valent pneumococcal conjugate
vaccine in Phase 3 development 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 worldwide and are not
contained in the pneumococcal conjugate vaccine currently licensed
for use in adults.
About Pneumococcal Disease
The global prevalence of pneumococcal disease, an infection
caused by bacteria called Streptococcus pneumoniae, is evolving.
Highly aggressive strains, or serotypes, threaten to put more
people at risk for non-invasive pneumococcal illnesses such as
pneumococcal pneumonia (when it is confined to the lungs),
sinusitis, and otitis media (middle ear infection), and invasive
pneumococcal illnesses such as pneumococcal bacteremia (infection
in the bloodstream), bacteremic pneumonia (pneumonia with
bacteremia) and pneumococcal meningitis (infection of the coverings
of the brain and spinal cord). While healthy adults and children
can suffer from pneumococcal disease, patient populations
particularly vulnerable to infection include children under the age
of 2, older adults such as those 65 years of age and older and
people with immunosuppressive or certain chronic health
conditions.
Indication for PNEUMOVAX 23 (Pneumococcal Vaccine
Polyvalent)
PNEUMOVAX 23 is a vaccine indicated for active immunization for
the prevention of pneumococcal disease caused by the 23 serotypes
contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A,
11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F and 33F).
PNEUMOVAX 23 is approved for use in persons 50 years of age or
older and persons aged ≥2 years who are at increased risk for
pneumococcal disease.
PNEUMOVAX 23 will not prevent disease caused by capsular types
of pneumococcus other than those contained in the vaccine.
Select Safety Information for PNEUMOVAX 23
Do not administer PNEUMOVAX 23 to individuals with a history of
a hypersensitivity reaction to any component of the vaccine.
Defer vaccination with PNEUMOVAX 23 in persons with moderate or
severe acute illness.
Use caution and appropriate care in administering PNEUMOVAX 23
to individuals with severely compromised cardiovascular and/or
pulmonary function in whom a systemic reaction would pose a
significant risk.
Available human data from clinical trials of PNEUMOVAX 23 in
pregnancy have not established the presence or absence of a
vaccine-associated risk.
Since elderly individuals may not tolerate medical interventions
as well as younger individuals, a higher frequency and/or a greater
severity of reactions in some older individuals cannot be ruled
out.
Persons who are immunocompromised, including persons receiving
immunosuppressive therapy, may have a diminished immune response to
PNEUMOVAX 23.
PNEUMOVAX 23 may not be effective in preventing pneumococcal
meningitis in patients who have chronic cerebrospinal fluid (CSF)
leakage resulting from congenital lesions, skull fractures or
neurosurgical procedures.
The most common adverse reactions, reported in >10% of
subjects vaccinated with PNEUMOVAX 23 for the first time in a
clinical trial, were: injection-site pain/soreness/tenderness,
injection-site swelling/induration, headache, injection-site
erythema, asthenia and fatigue, and myalgia.
For subjects aged 65 years or older in a clinical study,
systemic adverse reactions which were determined by the
investigator to be vaccine-related were higher following
revaccination than following initial vaccination.
Vaccination with PNEUMOVAX 23 may not offer 100% protection from
pneumococcal infection.
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).
Please see Prescribing Information for PNEUMOVAX 23 at
http://www.merck.com/product/usa/pi_circulars/p/pneumovax_23/pneumovax_pi.pdf
and Patient Information for PNEUMOVAX 23 at
http://www.merck.com/product/usa/pi_circulars/p/pneumovax_23/pneumovax_ppi.pdf.
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