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Systematic Review of 58 Publications of Real-World Use of GARDASIL® Presented at EUROGIN Congress

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside of the United States and Canada, announced today that in a systematic review conducted of the global impact and effectiveness of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant], substantial reductions were observed in HPV 6/11/16/18-related infection, genital warts, Pap abnormalities and cervical pre-cancers. This evaluation of 58 effectiveness and impact studies published during the past 10 years examined the use of GARDASIL in routine vaccination programs in Australia, Europe, North America and New Zealand, and will be presented for the first time during an oral session at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) congress in Austria. A paper detailing this review was also published online on June 14 in the journal Clinical Infectious Diseases (CID).

Following introduction of vaccination programs with GARDASIL, the earliest impact of the vaccine was seen in the reduction of genital warts. Reductions in genital warts were observed in all nine countries included in this review (based on 28 publications), with declines occurring as early as one year after vaccine introduction in Australia and Germany. Reductions in HPV 6/11/16/18 infection, assessed in 14 publications from five countries (Australia, Belgium, Germany, Sweden and the United States), were also observed shortly after vaccination; for example, reductions in HPV 6/11/16/18 infection were seen within four years in several studies from Australia and the United States. Subsequently, as successive birth cohorts began cervical screening, reductions in cervical pre-cancers were observed within 3-5 years of vaccine program implementation in Australia, Canada, Denmark, Sweden and the United States.

GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] is indicated for use in females 9 through 26 years of age for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18. GARDASIL is also approved for use in males 9 through 26 years of age for the prevention of anal cancer caused by HPV types 16 and 18, for the prevention of anal dysplasias and precancerous 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 contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL.

The review identified 58 studies published from January 2007 through February 2016 that met the pre-specified criteria for assessment of the real-world impact of vaccination with GARDASIL on HPV-related disease. These studies were conducted in nine different countries (Australia, Denmark, Sweden, Belgium, Germany, France, United States, Canada and New Zealand) with varying degrees of HPV vaccination coverage, among populations of different ages, and used different study methods and disease endpoints. Studies reporting only on the bivalent HPV vaccine were excluded. GARDASIL was predominantly, but not exclusively, used in all publications reviewed. Short-term endpoints (reduction in HPV infection and genital warts) and medium-term endpoints (reduction in Pap abnormalities and cervical pre-cancers) were assessed. Cervical cancer, however, was not identified because most vaccinated cohorts have not yet reached ages when cervical cancer is typically diagnosed. Thus the anticipated benefit of vaccination on certain HPV-related cancer rates cannot be fully determined yet, because of the long latency periods following exposure to HPV.

In this review of the studies, decreases in the prevalence of HPV 6/11/16/18 infections, genital warts, Pap abnormalities and cervical pre-cancers were observed among females in their teens and 20s subsequent to the introduction of GARDASIL. Decreases were generally highest in younger populations, reflecting a lower likelihood of pre-existing HPV infection at time of vaccination, supporting global recommendations for routine use of HPV vaccine in adolescents.

“Based on this comprehensive review of studies published during the past 10 years since the licensure of GARDASIL, reductions in HPV infections as well as reductions in the prevalence of HPV 6/11/16/18-related diseases, as noted by decreases in Pap abnormalities, cervical pre-cancers, and genital warts, were detected within four years after vaccine introduction,” said Professor Suzanne Garland, M.D., director of microbiological research and head of clinical microbiology and infectious diseases, The Royal Women's Hospital, Victoria, Australia, who will present these data at EUROGIN and is lead author on the CID publication. “Despite the progress we have made with Pap screening and vaccination, cervical cancer and other HPV-related diseases are still a public health issue in both developed and developing nations, which underscores the need for comprehensive HPV vaccination programs in adolescents before they’re at risk of contracting the virus,” added Garland.

Results varied depending on the vaccine coverage (percent of the population who had been vaccinated), breadth of the immunization program (the age range of those vaccinated and whether catch-up vaccination was included), the number of doses received, the study design, and the disease outcome assessed. The overall impact on the population was greatest in countries that achieved high vaccination rates soon after the introduction of GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] and in the youngest cohorts. For example, in Australia, a country with 3-dose vaccination coverage of 73 percent among adolescent females, prevalent HPV 6/11/16/18-related infection decreased by 86 percent in females 18-24 years of age after three doses within six years of vaccine introduction, compared to unvaccinated women during the same timeframe. Furthermore, a 92.6 percent reduction in genital warts diagnosed among females <21 years of age was observed four years after the vaccine program was initiated. Within four years of vaccine introduction in Australia, reductions in cervical pre-cancers were seen in females 11-27 years old at the start of the vaccination program in 2007 and who received all three vaccine doses, with declines ranging from 57 percent in females 15-18 years old to 5 percent in females 23-27 years old. Reductions in disease endpoints were generally lower in older individuals and in countries with lower vaccine coverage. For example, in the same Australian study where a 92.6 percent reduction in genital warts was observed in females <21 years of age, the reduction in genital warts in females 21-30 years of age was 72.6 percent. Reductions in genital warts were <50 percent in teens 15-19 years old in France and Germany where vaccine coverage was much lower than Australia.

"These data reinforce that GARDASIL is important in the fight against cervical cancer and certain other HPV-related cancers and diseases, however the full public health potential of HPV vaccination of males and females is not yet realized even after a decade of use,” said Jacques Cholat, M.D., president of Merck Vaccines. “Increasing HPV vaccination rates and access to the vaccine has the potential to make an even greater impact globally."

Systematic review of 58 peer-reviewed publications

This review synthesized available data assessed through a systematic search of PubMed and Embase for peer-reviewed manuscripts from January 2007 through February 2016. The search identified observational studies that reported on the impact or effectiveness of GARDASIL on HPV infection, genital warts, cervical abnormalities and pre-cancers. Both vaccine effectiveness and impact aim at evaluating ‘real-life benefit’ and are typically measured through observational studies. Vaccine impact denotes the population-prevented fraction of infection or disease and is assessed by comparing prevalence or incidence in the vaccine era to a comparable population from the prevaccine era or by measuring population-level trends over time. Vaccine effectiveness corresponds to the proportion of infection or disease prevented among vaccinated individuals, and is estimated by comparing the incidence in vaccinated versus unvaccinated individuals within similar populations. After screening 903 papers, 58 publications from nine countries met the pre-specified inclusion criteria.

Important information about GARDASIL ® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant]

GARDASIL does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening. Recipients of GARDASIL should not discontinue anal cancer screening if it has been recommended by a health care provider.

GARDASIL has not been demonstrated to provide protection against diseases from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity.

GARDASIL is not intended to be used for treatment of active external genital lesions; cervical, vulvar, vaginal and anal cancers; cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN).

GARDASIL has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine.

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 16 and 18.

GARDASIL does not protect against diseases not caused by HPV. Vaccination with GARDASIL may not result in protection in all vaccine recipients.

Select safety information for GARDASIL ® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant]

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 vaccination with GARDASIL. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion.

GARDASIL is not recommended for use in pregnant women.

The most common adverse reaction was headache. Common adverse reactions that were observed among recipients of GARDASIL at a frequency of at least 1.0 percent and greater than placebo were fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus and bruising.

Dosage and administration for GARDASIL

GARDASIL should be administered in 3 separate intramuscular injections in the deltoid region of the upper arm or in the higher anterolateral area of the thigh over a 6-month period with the first dose at an elected date, the second dose 2 months after the first dose, and the third dose 6 months after the first dose.

About GARDASIL

GARDASIL is approved for use in 132 countries. To date, more than 208 million doses have been distributed worldwide.

About HPV and related cancers and diseases

In the United States, human papillomavirus (HPV) will infect most sexually active males and females in their lifetime. According to the CDC, there are approximately 14 million new genital HPV infections in the United States each year, half of which occur in people 15 through 24 years of age. For most people, HPV clears on its own, but for others who don't clear the virus, it could lead to cancers and other diseases in males as well as females, and there is no way to predict who will clear the virus.

In women, HPV causes virtually all cervical cancer cases of which an estimated 70 percent are caused by HPV types 16 and 18. Each day another 35 women are diagnosed with cervical cancer in the United States — about 12,900 women per year. HPV also causes approximately 70-75 percent of vaginal cancer cases and approximately 30 percent of vulvar cancer cases. HPV types 16 and 18 cause an estimated 65% of hpv-related vaginal cancer cases and 75% of hpv-related vulvar cancer cases. Additionally, there are an estimated 3 million abnormal Pap results, many of which are caused by HPV, that require follow-up each year in the United States.

HPV causes approximately 85-90 percent of anal cancers in both males and females, and HPV types 16 and 18 cause an estimated 85% of those cases. According to the American Cancer Society, an estimated 2,600 men and 4,600 women in the United States will be diagnosed with anal cancer in 2015, and overall rates have been increasing. There is no routine screening recommended for the general population to screen for anal cancer.

HPV causes approximately 90 percent of genital warts in both males and females. There are approximately 360,000 cases of genital warts each year in the United States. Treatment of genital warts can be painful, and they may recur after treatment, especially in the first three months. Approximately 3 out of 4 people get them after having genital contact with someone who has genital warts.

About Merck

For 125 years, Merck has been a global health care leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook, 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. 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 2015 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 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 for GARDASIL at https://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_ppi.pdf .

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