Merck (NYSE: MRK), known as MSD outside of the United States and
Canada, today announced positive top-line results from its pivotal
Phase 3 trial (V503-064) evaluating the company’s 9-valent Human
Papillomavirus (HPV) vaccine, GARDASIL®9 (Human Papillomavirus
9-valent Vaccine, Recombinant) in Japanese males ages 16 to 26
years. The trial met its primary and secondary endpoints
demonstrating that administration of a 3-dose regimen of GARDASIL 9
reduced the combined incidence of anogenital persistent infection
caused by 9 types of HPV compared with a placebo.
“A decade after the first approval of GARDASIL 9, Merck
continues to evaluate this important vaccine in additional patient
populations and remains committed to helping prevent certain
HPV-related cancers through broad and equitable access globally,”
said Dr. Eliav Barr, senior vice president, head of global clinical
development and chief medical officer, Merck Research Laboratories.
“These data build on the clinical efficacy of GARDASIL 9 for the
prevention of persistent infection in males and can potentially
make a significant impact in addressing the global burden of
certain HPV-related cancers and diseases.”
Merck plans to share these data with regulatory authorities in
Japan and other countries around the world to support licensure for
use in males. The full results also will be presented at an
upcoming scientific congress. The clinical development program
evaluating GARDASIL 9 in males also includes an ongoing
confirmatory Phase 3 trial evaluating efficacy in preventing HPV
oral persistent infection to support effectiveness against
HPV-related oropharyngeal and other head and neck cancers
(NCT04199689).
About V503-064
V503-064 is a Phase 3, double-blind, placebo-controlled clinical
study (NCT04635423) to evaluate the safety/tolerability and
efficacy of GARDASIL 9 (V503) in preventing HPV-related anogenital
persistent infection in Japanese males 16 to 26 years of age.
GARDASIL 9 is commercialized in Japan under the name SILGARD 9.
The primary efficacy objective was to demonstrate reduction in
the incidence of HPV 6/11/16/18-related 6-month anogenital
persistent infection. The secondary efficacy objective was to
demonstrate reduction in the incidence of HPV
31/33/45/52/58-related 6-month anogenital persistent infection. The
study enrolled 1,059 participants.
About GARDASIL 9 in the U.S.
GARDASIL 9 is a vaccine indicated 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 human
papillomavirus (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 indicated 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.
GARDASIL 9 does 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 has 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 protects only
against those vulvar, vaginal, anal, oropharyngeal and other head
and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and
58.
GARDASIL 9 is 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 may not result in protection in all
vaccine recipients.
Select Safety Information
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].
Because vaccines 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 have not been established in pregnant
women. 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. The
duration of immunity of a 2-dose schedule of GARDASIL 9 has not
been established.
Dosage and Administration
GARDASIL 9 should be administered intramuscularly in the deltoid
or anterolateral area of the thigh.
- 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.
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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version on businesswire.com: https://www.businesswire.com/news/home/20240911570329/en/
Media Contacts: Julie Cunningham (617) 519-6264
julie.cunningham@merck.com Muchena Zigomo (267) 309-5591
muchena.zigomo@merck.com Investor Contacts: Peter Dannenbaum (732)
594-1579 peter.dannenbaum@merck.com Alexis Constantine (732)
594-1578 alexis.constantine@merck.com
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