Company reaffirms commitment to reduce the
global burden of HPV-related diseases, including certain
cancers
Merck (NYSE: MRK), known as MSD outside of the United States and
Canada, today, at the EUROGIN 2024 HPV Congress, announced plans to
initiate clinical development of a new investigational multi-valent
HPV vaccine designed to provide broader protection against multiple
HPV types. Separately, the company also plans to conduct clinical
trials in both females and males to evaluate the efficacy and
safety of a single-dose regimen of GARDASIL®9 (Human Papillomavirus
9-valent, recombinant), compared to the approved three-dose
regimen.
“Evidence continues to emerge showing the importance of GARDASIL
and GARDASIL 9 to public health,” said Dr. Eliav Barr, senior vice
president, head of global clinical development and chief medical
officer, Merck Research Laboratories. “These significant
investments build upon our leadership and importantly provide the
opportunity to further impact the global burden of certain
HPV-related cancers and disease.”
In the U.S., GARDASIL 9 is indicated for use in females 9
through 45 years of age for the prevention of cervical, vulvar,
vaginal, anal, oropharyngeal and other head and neck cancers caused
by HPV Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar,
vaginal, and anal precancerous or dysplastic lesions caused by HPV
Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts
caused by HPV Types 6 and 11. GARDASIL 9 is also indicated for use
in males 9 through 45 years of age for the prevention of anal,
oropharyngeal and other head and neck cancers caused by HPV Types
16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic
lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58;
and genital warts caused by HPV Types 6 and 11. The oropharyngeal
and head and neck cancer indication is approved under accelerated
approval based on effectiveness in preventing HPV-related
anogenital disease. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
a confirmatory trial. The confirmatory trial is ongoing. GARDASIL 9
is contraindicated in individuals with hypersensitivity, including
severe allergic reactions to yeast, or after a previous dose of
GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types
6, 11, 16, and 18) Vaccine, Recombinant].
Multivalent HPV vaccine research
Merck vaccine researchers continue to build on the development
of GARDASIL and GARDASIL 9 to identify new candidates with the
potential to extend protection against a broader array of HPV
types. The latest addition to the pipeline employs the company’s
proprietary virus-like particle (VLP) technology to incorporate
additional VLPs for expanded HPV type coverage. This includes
several types known to have more impact in African and Asian
populations and individuals of African and Asian descent.
First-in-human studies (Phase 1) are scheduled to start in the
fourth quarter of 2024.
Assessing the potential efficacy and durability of a single
dose regimen of GARDASIL 9
In response to calls from scientific leaders for more clinical
data concerning alternative dosing regimens for GARDASIL 9, Merck,
pending regulatory input, plans to conduct two prospective clinical
trials, one in females (16-26 years old) and one in males (ages
16-26 years old). These randomized, double-blind, multi-year
clinical trials will examine the short and long-term efficacy and
immunogenicity of a single-dose of GARDASIL 9 versus the currently
approved three-dose regimen. The goal of these large, randomized
trials is to generate data that clearly determines whether or not a
single dose of GARDASIL 9 provides comparable long-term protection
to the approved three-dose regimen, while also satisfying the high
standards required by regulatory authorities. The clinical trials
are anticipated to start enrolling participants in the fourth
quarter of 2024.
HPV vaccine supply
To address the increasing global demand for GARDASIL and
GARDASIL 9 and support broader and equitable access, Merck has made
significant investments in manufacturing to help increase supply.
Starting in 2019, the company committed to expand manufacturing
capacity by increasing production at existing plants as well as
constructing new facilities. Between 2017 and 2020 this resulted in
a near doubling of supply which has subsequently been doubled again
between 2020 and 2024. Merck expects to supply sufficient
quantities of HPV vaccines to meet anticipated demand for 2025 and
will continue to expand our supply capacity in the future.
Indication for GARDASIL and GARDASIL 9
GARDASIL 9 is a vaccine indicated in females 9 through 45 years
of age. GARDASIL is a vaccine indicated in females 9 through 26
years of age. GARDASIL 9 is indicated for the prevention of
cervical, vulvar, vaginal, anal, oropharyngeal and other head and
neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31,
33, 45, 52, and 58; and precancerous or dysplastic lesions caused
by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. GARDASIL is
indicated for the prevention of cervical, vulvar, vaginal, and anal
cancers caused by HPV Types 16 and 18, and precancerous or
dysplastic lesions caused by HPV Types 6, 11, 16, and 18. Both are
indicated for the prevention of genital warts caused by HPV Types 6
and 11.
GARDASIL 9 is indicated in males 9 through 45 years of age.
GARDASIL is indicated in males 9 through 26 years of age. GARDASIL
9 is indicated for the prevention of anal, oropharyngeal and other
head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52,
and 58; and precancerous or dysplastic lesions caused by HPV Types
6, 11, 16, 18, 31, 33, 45, 52, and 58. GARDASIL is indicated for
the prevention of anal cancer caused by HPV Types 16 and 18, and
precancerous or dysplastic lesions caused by HPV Types 6, 11, 16,
and 18. Both are indicated for the prevention of genital warts
caused by HPV Types 6 and 11.
The GARDASIL 9 oropharyngeal and head and neck cancer indication
is approved under accelerated approval based on effectiveness in
preventing HPV-related anogenital disease. Continued approval for
this indication may be contingent upon verification and description
of clinical benefit in a confirmatory trial.
Indication - Limitations of Use
GARDASIL 9 and GARDASIL do not eliminate the necessity for
vaccine recipients to undergo screening for cervical, vulvar,
vaginal, anal, oropharyngeal and other head and neck cancers as
recommended by a health care provider.
GARDASIL 9 and GARDASIL have not been demonstrated to provide
protection against diseases caused by:
- HPV types not covered by the vaccine
- HPV types to which a person has previously been exposed through
sexual activity
Not all vulvar, vaginal, anal, oropharyngeal and other head and
neck cancers are caused by HPV, and GARDASIL 9 and GARDASIL protect
only against those vulvar, vaginal, anal, oropharyngeal and other
head and neck cancers caused by HPV types contained in the
vaccines.
GARDASIL 9 and GARDASIL are not a treatment for external genital
lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other
head and neck cancers; or cervical intraepithelial neoplasia (CIN),
vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial
neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).
Vaccination with GARDASIL 9 or GARDASIL may not result in
protection in all vaccine recipients.
Select Safety Information
GARDASIL 9 and GARDASIL are contraindicated in individuals with
hypersensitivity, including severe allergic reactions to yeast, or
after a previous dose of GARDASIL 9 or GARDASIL.
Because vaccinees may develop syncope, sometimes resulting in
falling with injury, observation for 15 minutes after
administration is recommended. Syncope, sometimes associated with
tonic-clonic movements and other seizure-like activity, has been
reported following HPV vaccination. When syncope is associated with
tonic-clonic movements, the activity is usually transient and
typically responds to restoring cerebral perfusion.
Safety and effectiveness of GARDASIL 9 and GARDASIL have not
been established in pregnant women.
For GARDASIL 9, the most common (≥10%) local and systemic
adverse reactions in females were: injection-site pain, swelling,
erythema, and headache. The most common (≥10%) local and systemic
reactions in males were injection-site pain, swelling, and
erythema. For GARDASIL, the most common (≥1.0%) adverse reactions
were headache, fever, nausea, dizziness; and injection-site pain,
swelling, erythema, pruritus, and bruising.
The duration of immunity for a 2-dose regimen of GARDASIL 9 is
unknown.
Dosage and Administration
Administer either GARDASIL 9 or GARDASIL intramuscularly in the
deltoid or anterolateral area of the thigh.
For GARDASIL 9, a complete vaccination regimen consists of:
- For individuals 9 through 14 years of age, GARDASIL 9 can be
administered using a 2-dose or 3-dose schedule. For the 2-dose
schedule, the second dose should be administered 6–12 months after
the first dose. If the second dose is administered less than 5
months after the first dose, a third dose should be given at least
4 months after the second dose. For the 3-dose schedule, GARDASIL 9
should be administered at 0, 2 months, and 6 months.
- For individuals 15 through 45 years of age, GARDASIL 9 is
administered using a 3-dose schedule at 0, 2 months, and 6
months.
For GARDASIL, complete vaccination regimen for individuals aged
9 through 26 years of age consists of 3 doses at the following
schedule: 0, 2 months, 6 months.
About Merck
At Merck, known as MSD outside of the United States and Canada,
we are unified around our purpose: We use the power of leading-edge
science to save and improve lives around the world. For more than
130 years, we have brought hope to humanity through the development
of important medicines and vaccines. We aspire to be the premier
research-intensive biopharmaceutical company in the world – and
today, we are at the forefront of research to deliver innovative
health solutions that advance the prevention and treatment of
diseases in people and animals. We foster a diverse and inclusive
global workforce and operate responsibly every day to enable a
safe, sustainable and healthy future for all people and
communities. For more information, visit www.merck.com and connect
with us on X (formerly Twitter), Facebook, Instagram, YouTube and
LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Rahway,
N.J., USA
This news release of Merck & Co., Inc., Rahway, 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 candidates that
the candidates 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 Annual
Report on Form 10-K for the year ended December 31, 2023 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 GARDASIL 9 (Human
Papillomavirus 9-valent Vaccine, Recombinant) at
https://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_pi.pdf
and Patient Information/Medication Guide for GARDASIL 9 at
https://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_ppi.pdf
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