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FDA Approves Merck & Co., Inc. (MRK)'s (JOBS) GARDASIL(R) for Use in Boys and Young Men


10/19/2009 7:07:14 AM

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WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck & Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for use in boys and men 9 through 26 years of age for the prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11. FDA approval is the first step in an important two-step process. The next step in the process is an Advisory Committee on Immunization Practices vote on whether to recommend administration of GARDASIL for use in males, as well as public funding through the U.S. Centers for Disease Control and Prevention (CDC) contract. These votes are expected on October 21.

“We are pleased that GARDASIL is now available to help protect males," said Richard M. Haupt, M.D., MPH, executive director, Merck Research Laboratories. "This is an important milestone, because the use of GARDASIL can now help protect boys and girls and young men and women from certain diseases caused by this common virus." Approximately 75-80 percent of people acquire one or more types of HPV at some point in their lives. For most people, the virus will go away on its own. But, for some people who don't clear certain types of the virus, HPV diseases can develop, and there is no way to predict who will or won't clear the virus. According to the CDC, certain types of HPV are associated with precancers and cancer, including cervical, vulvar, and vaginal cancers in women. In addition, other HPV types cause genital warts in both women and men.

"Nearly 17,000 new cases of genital HPV infection, of any type, occur each day in the United States, in both males and females," said Anna Giuliano, Ph.D., H. Lee Moffitt Cancer Center, Tampa, Florida. "While most of these HPV infections clear on their own, this year alone, it is estimated that one million people in the U.S. will develop genital warts, which can cause discomfort and be distressing. Some resolve without treatment; but, for those that require treatment, warts recur in at least 25 percent of cases."

GARDASIL helps protect against the four types of HPV, specifically types 6, 11, 16, and 18 that cause the most disease. It is estimated that HPV types 16 and 18 account for 70 percent of cervical and vaginal cancer cases and up to 50 percent of vulvar cancer cases. Types 6 and 11 cause approximately 90 percent of all genital warts cases.

"Education about the prevalence of HPV infection and potential disease consequences, along with the benefits and limitations of vaccination with GARDASIL, is important," says Giuliano. "As with all vaccination programs, important factors in successful implementation include patient education, along with clear communications by health care professionals."

GARDASIL was approved in 2006 and is indicated for use in girls and young women 9 through 26 years of age for the prevention of cervical cancer, vulvar cancer, and vaginal cancer and pre-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 contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL.

Merck continues to support broad access to GARDASIL

The federally funded Vaccines for Children (VFC) program, if available, can provide free vaccines to eligible children through the age of 18. To address any funding challenges that may impede access to GARDASIL for people who are not in the VFC eligible age-range, starting November 1 the Merck Vaccine Patient Assistance Program (MVPAP) will be extended to cover 19- to 26-year-old uninsured males. The MVPAP, which was established in 2008 to add adult vaccines to Merck's Patient Assistance Program (PAP), currently provides GARDASIL free of charge to women 19-26 years old who meet the program criteria and who, without assistance, could not afford the vaccine.

Before the end of this year, Merck plans to implement its patient rebate and dose replacement programs for GARDASIL to support access for eligible privately insured males with partial or no coverage for the vaccine. The rebate program for GARDASIL enables eligible privately insured 19-26 year olds whose out-of-pocket costs are over $30 to receive a rebate from Merck for up to a maximum of $130 per dose. The dose replacement program provides a limited number of replacement doses of GARDASIL to eligible health care providers who learn after giving the vaccine to a qualifying patient that their private insurance provides no reimbursement.

GARDASIL works well in both males and females

At the completion of all pivotal clinical studies conducted in more than 20,500 young women aged 16 to 26 years of age over a period of three to four years, GARDASIL prevented 98 percent of HPV 16- and 18-related cervical pre-cancers (CIN 2/3 or AIS; two cases in the vaccine group; n=8,493 vs. 112 cases in the placebo group; n= 8,464) and 100 percent of HPV 16- and 18-related vulvar and vaginal pre-cancers; (VaIN 2/3 and VIN 2/3; no cases in the vaccine group; n=7,772 vs. 19 in the placebo group; n=7,744) in females who were naïve to the relevant HPV type(s) 6, 11, 16, and 18. Also, GARDASIL prevented 99 percent of genital warts (two cases in the vaccine group; n=7,900 vs. 193 cases in the placebo group; n=7,902).

In the Phase III studies over a period of three years of more than 4,000 males ages 16 to 26, GARDASIL was efficacious in reducing the incidence of genital warts related to HPV types 6 and 11 in males who were naïve to the relevant HPV type(s) 6, 11, 16, and 18. GARDASIL was 90.4 percent efficacious against HPV 6, 11, 16, and 18-related external genital lesions (EGL) (three cases in the vaccine group; n=1,397 vs. 31 cases in the placebo group; n=1,408). Of the 34 cases of EGL, 31 were genital warts. GARDASIL was 89 percent efficacious against HPV 6 and 11-related genital warts (three cases in the vaccine group; n=1,397 vs. 28 cases in the placebo group; n=1,408). There were three cases of HPV 6, 11, 16, or 18-related penile/perianal/perineal intraepithelial neoplasia (PIN) and all were in the placebo group. Vaccine efficacy against HPV 6, 11, 16, and 18-related PIN 1 or worse was not demonstrated, as the number of cases was too limited to reach statistical significance.

Duration of protection and continuing studies in women

While the duration of protection of GARDASIL has not been established, GARDASIL has demonstrated efficacy through five years in the extension phase (n=235) of a pivotal Phase II study of 551 women. The findings showed that GARDASIL was 100 percent effective in preventing overall cervical and genital disease related to HPV types 6, 11, 16, and 18 among subjects who were naïve to the relevant HPV types at baseline and through one month after receiving the third dose (n= 104). In that study, there were no breakthrough cases of disease through five years of follow up (cervical disease: no cases in the vaccine group vs. three cases in the placebo group; genital disease: no cases in the vaccine group vs. three cases in the placebo group).

Separately, in an extended follow up study of 290 women naïve to HPV type 16 at baseline and through one month after receiving the third dose, the HPV 16 component of GARDASIL was efficacious against HPV 16 infection and associated cervical lesions for an average of 8.5 years after administration (no cases of HPV 16 infection or HPV 16-associated cervical lesions in the vaccine group; n=148 vs. six cases of HPV 16 infection and three cases of HPV 16-associated lesions in the placebo group; n=142). The women enrolled in this study were a subset of the original Phase II HPV 16 proof-of-concept study between October 1998 and January 2004. They were enrolled in the extended follow-up study between March 2006 and May 2008. Follow up ranged from 7.2 years to up to 9.5 years.

Since 2003, Merck has been following the long-term impact of GARDASIL on the overall incidence of cervical precancers and cancers through the Nordic Cancer Registry program, a population-based study evaluating the efficacy and safety of GARDASIL. This Registry will last through at least 2013. Plans are underway for a long-term follow-up evaluation in adolescent males.

Important information about GARDASIL

GARDASIL may not fully protect everyone and does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening.

GARDASIL has not been demonstrated to provide protection against diseases from vaccine and non-vaccine HPV types to which a woman has previously been exposed through sexual activity. GARDASIL is not intended to be used for treatment of active genital warts; cervical, vulvar, and vaginal cancers; cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN) or vaginal intraepithelial neoplasia (VaIN).

GARDASIL has not been demonstrated to protect against diseases due to HPV types not contained in the vaccine. Not all vulvar and vaginal cancers are caused by HPV, and GARDASIL protects only against those vaginal and vulvar cancers caused by HPV types 16 and 18.

Select safety information

GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] 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 is a ready-to-use, three-dose, intramuscular vaccine. GARDASIL should be administered in three separate intramuscular injections in the deltoid region of the upper arm or in the higher anterolateral area of the thigh. 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 approved in 116 countries

GARDASIL (sold in some countries as SILGARD®) has been approved in 116 countries, and additional applications are currently under review with regulatory agencies in many more countries around the world.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.

Forward-looking statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2008, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.


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