Anal intraepithelial neoplasia

January 8, 2025 6:48 am ET GARDASIL is the first HPV vaccine approved for the prevention of certain HPV-related cancers and diseases in Chinese males RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the National Medical Products Administration (NMPA) of China approved GARDASIL ® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for use in males 9-26 years of age to help prevent certain HPV-related cancers and diseases. The approval makes GARDASIL the first HPV vaccine approved for use in males in China. GARDASIL is now indicated in China to prevent anal cancers caused by HPV Types 16 and 18, genital warts (condyloma acuminata) caused by HPV Types 6 and 11, and the following precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, and 18: grade 1, grade 2, and grade 3 anal intraepithelial neoplasia (AIN). “The approval of GARDASIL for use in males 9-26 years old in China is a significant step forward in advancing public health,” said Joseph Romanelli, president, Human Health International, Merck. “Since first approval, our HPV vaccines have helped protect over 50 million females in China from certain HPV-related cancers and diseases. With this expanded approval, we look forward to helping protect this new population of Chinese males from certain HPV-related cancers and diseases.” Indications for GARDASIL 1 GARDASIL is a vaccine indicated in females 9 through 45 years of age. GARDASIL is indicated for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV Types 16 and 18, precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, and 18, and for the prevention of genital warts caused by HPV Types 6 and 11. GARDASIL is indicated in males 9 through 26 years of age. 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, and for the prevention of genital warts caused by HPV Types 6 and 11. GARDASIL does not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, and anal cancers as recommended by a health care provider. GARDASIL 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, and anal cancers are caused by HPV, and GARDASIL protects only against those vulvar, vaginal, and anal cancers caused by HPV Types 6, 11, 16 and 18. GARDASIL 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 may not result in protection in all vaccine recipients. Select Safety Information for GARDASIL GARDASIL is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of 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 have not been established in pregnant women. 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 of GARDASIL has not been established. Dosage and Administration GARDASIL should be administered intramuscularly in the deltoid or anterolateral area of the thigh. For GARDASIL, a complete vaccination regimen for individuals 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 . About Merck’s global commitment to supply and access of HPV vaccines Merck is committed to working to ensure adequate global supply and supporting broader, equitable access to our HPV vaccines to help protect against certain HPV-related cancers and diseases. To realize this commitment, Merck has made 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 [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] at https://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf and Patient Information/Medication Guide for GARDASIL at https://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_ppi.pdf . 1 GARDASIL is no longer marketed in the United States. Media Contacts: Olivia Finucane +44 (7881) 262476 Muchena Zigomo +1 (267) 309-5591 Investor Contacts: Peter Dannenbaum +1 (732) 594-1579 Damini Chokshi +1 (732) 594-1577 Source: Merck & Co., Inc.

The National Medical Products Administration has approved several new indications for the Gardasil vaccine (quadrivalent human papillomavirus vaccine, yeast-derived) by Merck & Co., suitable for males aged 9 to 26. This approval makes Gardasil the first and currently the only HPV vaccine approved for males in China. The newly approved indications allow Gardasil to prevent anal cancer caused by HPV types 16 and 18 in males aged 9-26, as well as genital warts (condyloma acuminatum) caused by HPV types 6 and 11. Additionally, the vaccine is also indicated for preventing grade 1, 2, and 3 anal intraepithelial neoplasia (AIN) caused by HPV types 6, 11, 16, and 18. Anna Tan, Senior Vice President of Merck Global and President of Merck China, stated: “The approval of multiple new indications for Gardasil in China marks a significant milestone after six years. This not only signifies Gardasil as the first approved HPV vaccine for males domestically but also contributes new strength to the development of public health in China.” Since the approval of Merck’s HPV vaccine in China, it has protected the health of 51 million Chinese women. Merck believes that the approval of the new indications will further help protect more eligible males. The company will continue to fulfill its commitments in China, working closely with all sectors of society to raise public awareness of HPV-related diseases. Merck understands the importance of promoting HPV prevention for both genders and plans to strengthen cooperation with the government to significantly improve the accessibility and affordability of HPV vaccines, supporting the implementation and advancement of the Healthy China 2030 strategy.

November 12, 2024 3:00 am ET 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 a nd 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.