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Data Published in The Lancet Show GARDASIL® was 100 Percent Effective in Preventing High-Grade Vulvar and Vaginal Lesions Caused by HPV Types 16 and 18


WHITEHOUSE STATION, N.J.- Results published this week in The Lancet show that Merck’s cervical cancer vaccine, GARDASIL [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine] was 100 percent effective in preventing high-grade vulvar and vaginal dysplasias caused by HPV types 16 and 18, two types strongly associated with these diseases. The 100 percent protection was observed in women who were not infected with HPV types targeted by the vaccine -- 6, 11, 16 and 18 -- at the start of the study and through one month after receiving the third dose. Data published in The Lancet represent an additional year of follow up since data were presented to the U.S. Food and Drug Administration (FDA) for approval of GARDASIL.

“This combined analysis provides additional data showing that GARDASIL protected against HPV-16 and 18 related high-grade vulvar and vaginal lesions in women ages 16-26,” said Marc Steben, M.D., CCFP, family physician, HPV Scientific Group, Institut National de Sante Publique du Quebec, Canada. “Although HPV 16 and 18 do not cause all cases of vulvar and vaginal cancer, they account for a high proportion of cases in young women.”

“We are pleased to report data that continue to show that GARDASIL helps to protect against the four HPV types known to cause genital warts and low grade lesions in addition to cervical cancer, and vulvar and vaginal pre-cancers,” said Richard M. Haupt, M.D., MPH, executive director of Medical Affairs, Merck Vaccines.

GARDASIL was approved by the FDA on June 8, 2006, and is recommended for use by girls and women ages 11 to 26 by the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. GARDASIL is indicated for the prevention of HPV types 16- and 18- related cervical cancer, non-invasive cervical cancer [cervical intraepithelial neoplasia (CIN) grade 3 and adenocarcinoma in situ (AIS)], cervical pre-cancers [cervical intraepithelial neoplasia (CIN) grade 2], vulvar pre-cancers [vulvar intraepithelial neoplasia (VIN) 2/3] and vaginal pre-cancers [vaginal intraepithelial neoplasia (VaIN) 2/3], and for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18. GARDASIL is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine.

High grade vulvar and vaginal lesions indicators for possible development of cancer
The studies used for this analysis combine findings from one phase II study and two phase III studies - Protocol 007, Protocol 013 (FUTURE I) and Protocol 015 (FUTURE II), respectively. All three studies were double-blind, placebo-controlled randomized studies and were conducted at 157 sites in 24 countries. More than 18,000 women participated in the three trials and were between the ages of 16 to 26 at the time of enrollment. They received three doses of either GARDASIL or placebo at day one, month two and month six. The combined analysis evaluated the impact of GARDASIL on the incidence of high-grade vulvar and vaginal pre-cancers (VIN 2/3 and VaIN 2/3), common precursors to vulvar and vaginal cancers in younger women, caused by HPV types 16 and 18.

In the per-protocol population of this combined analysis, GARDASIL was 100 percent effective in preventing HPV 16- and 18-related VIN 2/3 and VaIN 2/3 in women who were not exposed to the relevant HPV types until at least one month after completing the vaccination series; no cases were observed in the vaccine group (n=7,811) compared to 15 cases in the placebo group (n=7,785).

In the unrestricted population of this combined analysis, GARDASIL was 97 percent effective in preventing HPV 16- and 18-related VIN 2/3 and VaIN 2/3 in women who may have been exposed to the relevant HPV types before completing the vaccination series; one case was observed in the vaccine group (n=8,757) compared to 29 cases in the placebo group (n=8,774).

Impact of GARDASIL in women already infected with HPV types targeted by the vaccine
This study also assessed the efficacy of GARDASIL in a broader population, including those who had HPV 6-, 11-, 16- or 18-related infection or disease at study initiation. In this group, GARDASIL reduced the incidence of HPV 16- or 18- related VIN 2/3 or VaIN 2/3 by 71 percent; nine cases were observed in the vaccine group (n= 9,087); 31 cases were observed in the placebo group (n=9,087).

In eight of the nine vaccine cases and two of the placebo cases, individuals were infected with HPV 16 or 18 prior to receiving the first dose. There were also five cases of VIN 2/3 or VaIN 2/3 in the placebo group that were associated with HPV type 6 and not associated with type 16 or 18. None were associated with HPV type 11.

In all three studies used in the analysis, the adverse events observed were similar to what has been previously reported. The most common treatment-related adverse event was injection-site pain.

Additional important information about GARDASIL
The health-care provider should inform the patient, parent or guardian that vaccination does not substitute for routine cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care.

Vaccination with GARDASIL may not result in protection in all vaccine recipients. GARDASIL is not intended to be used for treatment of active genital warts; cervical cancer; CIN, VIN, or VaIN. GARDASIL has not been shown to protect against disease due to other HPV types.

In clinical studies for GARDASIL, vaccine-related adverse experiences that were observed at a frequency of at least 1.0 percent among recipients of GARDASIL and also greater than those observed among recipients of placebo, respectively, were pain (83.9 percent vs. 75.4 percent), swelling (25.4 percent vs. 15.8 percent), erythema (24.6 percent vs. 18.4 percent), fever (10.3 percent vs. 8.6 percent), nausea (4.2 percent vs. 4.1 percent), pruritis (3.1 percent vs. 2.8 percent) and dizziness (2.8 percent vs. 2.6 percent).

Dosage and administration for GARDASIL
GARDASIL is a ready-to-use, three-dose, intramuscular vaccine. GARDASIL should be administered in three separate intramuscular injections in the upper arm or upper anterior thigh over a six-month period. The following dosage schedule is recommended: first dose at elected date, second dose two months after the first dose and the third dose six months after the first dose.

GARDASIL is widely available throughout the United States
There is broad private and public health insurance coverage for GARDASIL. Health plans covering approximately 98 percent of privately insured lives in the U.S. (currently more than 140 insurance plans) have implemented coverage for GARDASIL; however, individual benefit coverage and rates provided by health plans may vary.

GARDASIL was also added to the Vaccines for Children (VFC) Program on November 1, 2006, providing coverage for many who do not have private health insurance. All of the 55 immunization projects in the U.S. have adopted GARDASIL and most are filling provider orders.

Merck has also initiated a new patient assistance program for vaccines. Through this program, currently available in private physicians’ offices and private clinics, Merck is making available, free of charge, GARDASIL and other Merck vaccines indicated for use in individuals ages 19 and older who are uninsured and who are unable to afford vaccines.

GARDASIL is approved in more than 70 countries
GARDASIL (sold in some countries as SILGARD®) has been approved in more than 70 countries, including the United States, the 27 countries of the European Union, Mexico, Australia, Taiwan, Canada, New Zealand and Brazil, and additional applications are currently under review with regulatory agencies in many more countries around the world. Merck will donate free vaccine to the non-profit organization PATH to support demonstration studies designed to accelerate the availability of cervical cancer vaccines in the most impoverished nations. PATH is funded by a grant from the Bill & Melinda Gates Foundation. Merck is also working with India’s Council of Medical Research to study GARDASIL in India. Merck will make its new vaccines, including GARDASIL, available to developing world countries at dramatically lower prices.

HPV is a common infection
In the United States, approximately 20 million people are infected with HPV, and approximately 80 percent of females will have acquired HPV by age 50. For most people, HPV goes away on its own; however in some, certain high-risk types of HPV, if unrecognized and untreated, can lead to cervical cancer. Cervical cancer is the second most common cause of cancer death in women worldwide, resulting in nearly a half-million diagnoses and 240,000 deaths each year. It is estimated that in 2007, there will be approximately 11,150 new cases of cervical cancer and 3,700 deaths in the United States. Approximately 6,000 cases of vulvar or vaginal cancer are diagnosed annually in the U.S.

It is estimated that in 2007, vulvar and vaginal cancer will strike more than 5,600 women in the U.S. Vulvar and vaginal cancers, specifically those related to HPV infection, are becoming more common in young women. The incidence of vulvar cancers increased more than 400 percent between 1973 and 2000, and invasive vulvar cancer increased 20 percent during the same time period.

Certain low-risk types of HPV cause genital warts and can lead to abnormal Pap results. Approximately one million cases of genital warts occur each year in the United States and an estimated 32 million cases occur worldwide. Additionally, there are an estimated 4.7 million abnormal Pap results that require follow-up each year in the United States. At least 3 million of these results are caused by some type of HPV.

Other Information about GARDASIL
In 1995, Merck entered into a license agreement and research collaboration with CSL Limited of Australia relating to technology used in GARDASIL. GARDASIL also is the subject of other third-party licensing agreements.

Merck recently announced that it submitted a supplemental Biologics License Application (sBLA) to the FDA that includes efficacy data showing GARDASIL offers some protection against additional cervical cancer causing HPV types responsible for greater than 10 percent of cervical cancers, data on protection against additional gynecological cancers -- vulvar and vaginal -- and data on immune memory.


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