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Merck to Present New Data From GARDASIL®9 Studies Reinforcing the Importance of Gender-Neutral HPV Vaccination in Adults Up to Age 45 at the International Papillomavirus Conference (IPVC) 2024

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Merck (MRK) announced new clinical and real-world data presentations for GARDASIL®9, their 9-valent HPV vaccine, at the International Papillomavirus Conference (IPVC) 2024 in Edinburgh. The presentations include results from the BROADEN and PROGRESS studies focusing on oral HPV infection prevalence and HPV-related cancers.

The data reinforces the importance of HPV vaccination for both males and females aged 9-45, highlighting that disease-causal HPV infection can occur later in life. Globally, approximately 666,000 new diagnoses of certain HPV-related cancers occur annually in men and women. The studies emphasize the growing incidence of HPV-related oropharyngeal and head and neck cancers, particularly in men.

Merck (MRK) ha annunciato nuove presentazioni di dati clinici e del mondo reale per GARDASIL®9, il loro vaccino HPV a 9 valenze, presso la International Papillomavirus Conference (IPVC) 2024 a Edimburgo. Le presentazioni includono i risultati degli studi BROADEN e PROGRESS che si concentrano sulla prevalenza dell'infezione orale da HPV e sui tumori correlati all'HPV.

I dati rafforzano l'importanza della vaccinazione contro l'HPV per entrambi i sessi, dai 9 ai 45 anni, sottolineando che l'infezione da HPV, causa di malattia, può verificarsi più tardi nella vita. A livello globale, si registrano circa 666.000 nuove diagnosi di certi tumori correlati all'HPV ogni anno, sia negli uomini che nelle donne. Gli studi evidenziano l'aumento dell'incidenza dei tumori orofaringei e testa-collo legati all'HPV, in particolare negli uomini.

Merck (MRK) anunció nuevas presentaciones de datos clínicos y del mundo real para GARDASIL®9, su vacuna contra el VPH de 9 valores, en la International Papillomavirus Conference (IPVC) 2024 en Edimburgo. Las presentaciones incluyen resultados de los estudios BROADEN y PROGRESS centrados en la prevalencia de la infección oral por VPH y los cánceres relacionados con el VPH.

Los datos refuerzan la importancia de la vacunación contra el VPH para hombres y mujeres de entre 9 y 45 años, destacando que la infección por VPH, causante de enfermedades, puede ocurrir más tarde en la vida. A nivel mundial, aproximadamente 666,000 nuevos diagnósticos de ciertos cánceres relacionados con el VPH ocurren anualmente en hombres y mujeres. Los estudios enfatizan el creciente incremento de los cánceres orofaríngeos y de cabeza y cuello relacionados con el VPH, particularmente en hombres.

머크 (MRK)가 에든버러에서 열린 국제 유두 바이러스 회의 (IPVC) 2024에서 그들의 9가 HPV 백신 GARDASIL®9에 대한 새로운 임상 및 실제 데이터 발표를 알렸습니다. 발표 내용에는 구강 HPV 감염 유병률 및 HPV 관련 암에 초점을 맞춘 BROADEN 및 PROGRESS 연구의 결과가 포함됩니다.

이 데이터는 9세에서 45세 사이의 남녀를 위한 HPV 백신 접종의 중요성을 강화하며, 질병 유발 HPV 감염이 인생의 후반에 발생할 수 있음을 강조합니다. 전 세계적으로 매년 약 666,000건의 새로운 진단이 남녀 모두에서 HPV 관련 특정 암으로 발생하고 있습니다. 연구는 남성에서 특히 증가하는 HPV 관련 구강 인두 및 두경부 암의 발생률을 강조합니다.

Merck (MRK) a annoncé de nouvelles présentations de données cliniques et du monde réel pour GARDASIL®9, leur vaccin HPV à 9 valent, lors de la International Papillomavirus Conference (IPVC) 2024 à Édimbourg. Les présentations comprennent les résultats des études BROADEN et PROGRESS axées sur la prévalence des infections buccales à HPV et des cancers liés au HPV.

Les données renforcent l'importance de la vaccination contre le HPV pour les hommes et les femmes âgés de 9 à 45 ans, soulignant que l'infection causale des maladies par le HPV peut survenir plus tard dans la vie. À l'échelle mondiale, environ 666 000 nouveaux diagnostics de certains cancers liés au HPV sont enregistrés chaque année chez les hommes et les femmes. Les études soulignent l'augmentation de l'incidence des cancers oropharyngés et des cancers de la tête et du cou liés au HPV, en particulier chez les hommes.

Merck (MRK) gab neue klinische und reale Datenpräsentationen für GARDASIL®9, ihren 9-valenten HPV-Impfstoff, auf der International Papillomavirus Conference (IPVC) 2024 in Edinburgh bekannt. Die Präsentationen umfassen Ergebnisse der BROADEN und PROGRESS Studien, die sich auf die Prävalenz von oralen HPV-Infektionen und HPV-assoziierten Krebsarten konzentrieren.

Die Daten unterstreichen die Bedeutung der HPV-Impfung für Männer und Frauen im Alter von 9 bis 45 Jahren und heben hervor, dass HPV-Infektionen, die Krankheiten verursachen, später im Leben auftreten können. Weltweit werden jährlich etwa 666.000 neue Diagnosen bestimmter HPV-assoziierter Krebserkrankungen bei Männern und Frauen festgestellt. Die Studien betonen die steigende Inzidenz von HPV-assoziierten Oropharynx- und Kopf-Hals-Krebs, insbesondere bei Männern.

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RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that new clinical and real-world data for the company’s 9-valent Human Papillomavirus (HPV) vaccine, GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant), evaluating the burden and incidence of certain HPV-related cancers and diseases, will be presented at the International Papillomavirus Conference (IPVC) 2024 in Edinburgh, UK, from November 12-15.

Data to be presented include results from the BROADEN and PROGRESS studies evaluating the prevalence of oral HPV infection and burden of HPV-related oropharyngeal and other head and neck cancers, as well as studies evaluating the age of disease-causal HPV infection among females and highlighting the importance of protecting both females and males from HPV-related cancers and diseases through vaccination.

“These data support the value of adult vaccination and strengthen our understanding that disease-causal HPV infection can happen later in life, reinforcing the importance of HPV vaccination for both females and males beginning at age 9,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “While historically the HPV vaccination conversation has focused on preventing certain HPV-related cervical cancers in women, we also continue to see the growing incidence of HPV-related oropharyngeal and other head and neck cancers, particularly in men. In both men and women globally, there are approximately 666,000 new diagnoses of certain HPV-related cancers annually. The breadth of data we are presenting at the conference continues to demonstrate the link between HPV and certain HPV-related cancers in males and females and the role HPV vaccination can play in prevention.”

Details on key abstracts for Merck:

New Data Analyses of HPV-Related Cancers and Diseases in Women and Men

Abstract Title

Details

Immunogenicity Of 9-Valent HPV (9VHPV) Vaccine In Male Clinical Trial Participants: A Post-Hoc Analysis By Baseline Demographic Characteristics. A. Luxembourg.

ID #2172. TOPIC AS02: CLINICAL RESEARCH. CLINICAL SCIENCE ORAL ABSTRACT SESSION 05: HPV VACCINES

Sequential Human Papillomavirus Infection Between Anogenital Anatomical Sites In Men. G. Nahhas.

Poster #230. Session: 1

Estimating The Age of Acquisition of Disease-Causal HPV Infection Onset In Women Who Develop CIN2+ In England. K. Engelbrecht.

Poster #209. Session: 1

Estimating The Age Of Disease-Causal HPV Infection Based On The Natural History Of CIN2+ Among Females In Canada. A. Cherif.

Poster #219. Session: 2

Data Assessing Burden of Oral HPV Infection and HPV-Related Head and Neck Cancers in Men and Women

Abstract Title

Details

Oral Human Papillomavirus Prevalence And Genotyping Among Adults In The United Kingdom – PROGRESS Study. O. Ovcinnikova.

Poster #229. Session: 1

Oral Human Papillomavirus Incidence Among A General Adult Population In The US: Results From The PROGRESS (Prevalence Of Oral HPV Infection, A Global Assessment) Study. M. Felsher.

Poster #228. Session: 1

Preliminary Results Of The BROADEN Study: Burden Of Human Papillomavirus-Related Head And Neck Cancers. T. Waterboer.

ID#1292. TOPIC AS03: PUBLIC HEALTH, EPIDEMIOLOGY AND IMPLEMENTATION SCIENCE. ORAL ABSTRACTS SESSION 01: HPV AND HPV-DRIVEN CANCER IN THE HEAD AND NECK

The BROADEN-China Study: Increasing Burden of Human Papillomavirus-Related Head and Neck Cancers in China. S. Zhang.

ID#2397. TOPIC AS03: PUBLIC HEALTH, EPIDEMIOLOGY AND IMPLEMENTATION SCIENCE. ORAL ABSTRACTS SESSION: PUBLIC HEALTH LATE BREAKING ORAL ABSTRACTS

Indication for GARDASIL 9

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 for GARDASIL 9

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 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 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.

About Merck’s global commitment to supply and access to HPV vaccines

Merck is committed to ensuring adequate global supply and supporting broader, equitable access to our HPV vaccines to help protect against certain HPV-related cancers and diseases.

This commitment is enabled through significant capital investments, including more than $2 billion to help increase capacity through additional manufacturing facilities that allowed for a nearly doubling of supply of our HPV vaccines from 2017-2020 and then, supply was doubled again between 2020-2024 to address increasing global demand. As a result, we expect to supply sufficient quantities of our HPV vaccines to meet anticipated demand and will continue to expand supply capacity in the future.

Global equitable access to our HPV vaccines is a key part of our efforts and key partnerships help us achieve these goals. In 2024, Merck reaffirmed its commitment to Gavi, the Vaccine Alliance, through an agreement with UNICEF, to supply low- and middle-income countries with over 115 million doses of HPV vaccine by 2025, to appropriately support local immunization programs. Merck has consistently increased our supply commitment to Gavi from 1.7 million doses in 2017 to more than 30 million doses in 2024.

Additionally, we are working to ensure continued supply in countries with existing HPV vaccination programs and currently supply approximately 150 National Immunization Programs globally.

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. 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

Media Contacts:

Julie Cunningham

+1 (617) 519-6264



Muchena Zigomo

+1 (267) 309-5591

Investor Contacts:

Peter Dannenbaum

+1 (732) 594-1579



Damini Chokshi

+1 (732) 594-1577

Source: Merck & Co., Inc.

FAQ

What new data is Merck (MRK) presenting at IPVC 2024 for GARDASIL 9?

Merck is presenting results from the BROADEN and PROGRESS studies, focusing on oral HPV infection prevalence and HPV-related cancers, along with data on disease-causal HPV infection age in females and the importance of gender-neutral vaccination.

What age group is GARDASIL 9 (MRK) approved for?

GARDASIL 9 is approved for both males and females aged 9 through 45 years for the prevention of various HPV-related cancers and diseases.

How many new HPV-related cancer diagnoses occur annually according to Merck's (MRK) data?

According to the data, approximately 666,000 new diagnoses of certain HPV-related cancers occur annually in men and women globally.

What is the dosing schedule for Merck's (MRK) GARDASIL 9?

For ages 9-14, GARDASIL 9 can be given in 2 doses (6-12 months apart) or 3 doses. For ages 15-45, it requires 3 doses at 0, 2, and 6 months.

Merck & Co., Inc.

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